Sertraline Pediatric Registry for the Evaluation of Safety (SPRITES) (SPRITES)

SPRITES: SERTRALINE PEDIATRIC REGISTRY FOR THE EVALUATION OF SAFETY A NON-INTERVENTIONAL, LONGITUDINAL, COHORT STUDY TO EVALUATE THE EFFECTS OF LONG-TERM SERTRALINE TREATMENT IN CHILDREN AND ADOLESCENTS

To evaluate the long-term impact of treatment with sertraline on aspects of cognitive, emotional and physical development and pubertal maturation in pediatric subjects ages 6 to 16 years (inclusive) with a diagnosis of anxiety disorder, depressive disorder or obsessive compulsive disorder.

Study Overview

• Status: Completed
• Conditions: Obsessive Compulsive Disorder
• Intervention / Treatment: Drug: sertraline; Behavioral: psychotherapy

Detailed Description

Purposive sample: patients are not randomly selected, that is, he or she must meet certain inclusion criteria in order to qualify as a potential study participant.

• Study Type: Observational
• Enrollment (Actual): 941

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Dothan, Alabama, United States, 36303
      • Harmonex Neuroscience Research
  • California
    • Imperial, California, United States, 92251
      • Sun Valley Research Center
    • Los Angeles, California, United States, 90024
      • UCLA Semel Institute
  • Connecticut
    • Hartford, Connecticut, United States, 06106
      • Institute of Living/Hartford Hospital
    • Norwich, Connecticut, United States, 06360
      • Comprehensive Psychiatric Care
  • Florida
    • Gainesville, Florida, United States, 32610
      • University of Florida
    • Jacksonville, Florida, United States, 32207
      • Nemours Children's Clinic, Dept. of Psychology and Psychiatry
    • Orange City, Florida, United States, 32763
      • Medical Research Group of Central Florida
    • Pensacola, Florida, United States, 32502
      • Harmonex Neuroscience of Pensacola
    • Saint Petersburg, Florida, United States, 33701
      • University of South Florida - Rothman Center
  • Georgia
    • Augusta, Georgia, United States, 30912
      • Georgia Regents University Augusta
    • Smyrna, Georgia, United States, 30080
      • Institute For Behavioral Medicine, Llc
  • Illinois
    • Plainfield, Illinois, United States, 60585
      • Family Behavioral Health
  • Kansas
    • Kansas City, Kansas, United States, 66160-7341
      • University of Kansas School of Medicine/Dept. of Psychiatry
    • Topeka, Kansas, United States, 66606
      • Family Service and Guidance Center
  • Maryland
    • Baltimore, Maryland, United States, 21205
      • Kennedy Krieger Institute
    • Rockville, Maryland, United States, 20852
      • Neuroscientific Insights
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
    • South Yarmouth, Massachusetts, United States, 02664
      • Debora A. LaMonica, MD
    • Springfield, Massachusetts, United States, 01199
      • Baystate Medical Center, Child Behavioral Health Research
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • Missouri
    • Gladstone, Missouri, United States, 64118
      • Comprehensive Psychiatric Associates
    • Springfield, Missouri, United States, 65804
      • Saint John's Clinic
  • New Jersey
    • Neptune, New Jersey, United States, 07753
      • Jersey Shore University Medical Center/Meridian Health
    • Toms River, New Jersey, United States, 08755
      • Children's Specialized Hospital
  • New York
    • Rochester, New York, United States, 14618
      • Finger Lakes Clinical Research
  • North Carolina
    • Cary, North Carolina, United States, 27513
      • 3-C Family Services, P.A.
    • Durham, North Carolina, United States, 27705
      • Duke University Medical Center, Division of Child & Adolescent Psychiatry
    • Wilmington, North Carolina, United States, 28401
      • Scott George Crowder, M.D.
  • Ohio
    • Chagrin Falls, Ohio, United States, 44023
      • Family Center by the Falls
    • Cincinnati, Ohio, United States, 45219
      • University of Cincinnati
    • Cincinnati, Ohio, United States, 45220
      • Cincinnati Childrens Hospital and Medical Center
    • Cleveland, Ohio, United States, 44106
      • Case Western Reserve University, Department of Psychiatry Child/Adolescent
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73116
      • Cutting Edge Research Group
  • Pennsylvania
    • Havertown, Pennsylvania, United States, 19083
      • Child Guidance Resource Center
  • Tennessee
    • Tullahoma, Tennessee, United States, 37388
      • Tullahoma Pediatrics PLLC
  • Texas
    • Dallas, Texas, United States, 75235
      • University of Texas Southwestern Medical Center at Dallas
    • Friendswood, Texas, United States, 77546
      • Bay Pointe Behavioral Health Service, Inc.
    • Houston, Texas, United States, 77007
      • Midtown Psychiatry and TMS Center
    • Houston, Texas, United States, 77058
      • Peter Ly MD
    • San Antonio, Texas, United States, 78229
      • Focus and Balance, LLC
  • Virginia
    • Charlottesville, Virginia, United States, 22903
      • University of Virginia Health System
    • Petersburg, Virginia, United States, 23805
      • Clinical Research Partners, LLC
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53227
      • McLean Hospital - Harvard Medical School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 16 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The accessible population is children meeting inclusion/exclusion criteria from US centers in various clinical settings, including the Child and Adolescent Psychiatry Trials Network (CAPTN). From these, the study-eligible population (all children age 6 to 16 (inclusive) with an anxiety, depressive, or obsessive-compulsive disorder, who are exposed to sertraline under real-world conditions) will comprise an inception cohort of enrolled subjects beginning treatment for one of the study-qualifying disorders with sertraline or psychotherapy.

Description

Inclusion Criteria:

• Children age 6 to 16 (inclusive) with anxiety, depression, or obsessive-compulsive disorder, receiving treatment in outpatient setting, and who are prescribed a new prescription for sertraline to treat one of the above study-qualifying disorders or beginning psychotherapy for same.

Exclusion Criteria:

• Psychotic at study entry
• Diagnosis of bipolar disorder
• Diagnosis of schizoaffective or schizophrenia
• Anorexia
• Bulimia or eating disorder not otherwise specified (NOS)
• Autism
• Pervasive developmental disorder
• High risk of suicide within 2 weeks of initiating study treatment
• Significant mental retardation
• Taking an antidepressant medication other than sertraline, first or second generation antipsychotic, lithium, psychostimulant

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Sertraline-treated; enrolled subjects beginning treatment for one of the study qualifying disorders with sertraline	Drug: sertraline; Non interventional study - drug, dose, duration etc as per USPI and clinician discretion
psychotherapy only; enrolled subjects beginning treatment for one of the study qualifying disorders with psychotherapy	Behavioral: psychotherapy; Non-interventional study- as above

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Cognitive Function Using Trails B at Month 3	Trail B test is a set of shifting task, in which participants were asked to drawn a line from number 1 to letter A, then to number 2, then to letter B, then to number 3, then to letter C then so forth until they connected the circles as quickly as possible, without lifting pen or pencil from the paper. Participant was timed (maximum time limit was 300 seconds or 5 minutes) to connect the "trail." If the participant made an error, and it was pointed out immediately, the participant was allowed to correct it. Errors affected the participant's score only in that the correction of errors was included in the completion time for the task. A higher number of errors was indicative of a higher cognitive deficit. Raw results were the number of seconds required to complete the task; therefore, higher scores reveal greater impairment. Raw results based on age norms were transformed to Z-scores. Z-score = actual value minus normative value divided by standard deviation.	Baseline, Month 3
Change From Baseline in Cognitive Function Using Trails B at Month 6	Trail B test is a set of shifting task, in which participants were asked to drawn a line from number 1 to letter A, then to number 2, then to letter B, then to number 3, then to letter C then so forth until they connected the circles as quickly as possible, without lifting pen or pencil from the paper. Participant was timed (maximum time limit was 300 seconds or 5 minutes) to connect the "trail." If the participant made an error, and it was pointed out immediately, the participant was allowed to correct it. Errors affected the participant's score only in that the correction of errors was included in the completion time for the task. A higher number of errors was indicative of a higher cognitive deficit. Raw results were the number of seconds required to complete the task; therefore, higher scores reveal greater impairment. Raw results based on age norms were transformed to Z-scores. Z-score = actual value minus normative value divided by standard deviation.	Baseline, Month 6
Change From Baseline in Cognitive Function Using Trails B at Month 12	Trail B test is a set of shifting task, in which participants were asked to drawn a line from number 1 to letter A, then to number 2, then to letter B, then to number 3, then to letter C then so forth until they connected the circles as quickly as possible, without lifting pen or pencil from the paper. Participant was timed (maximum time limit was 300 seconds or 5 minutes) to connect the "trail." If the participant made an error, and it was pointed out immediately, the participant was allowed to correct it. Errors affected the participant's score only in that the correction of errors was included in the completion time for the task. A higher number of errors was indicative of a higher cognitive deficit. Raw results were the number of seconds required to complete the task; therefore, higher scores reveal greater impairment. Raw results based on age norms were transformed to Z-scores. Z-score = actual value minus normative value divided by standard deviation.	Baseline, Month 12
Change From Baseline in Cognitive Function Using Trails B at Month 18	Trail B test is a set of shifting task, in which participants were asked to drawn a line from number 1 to letter A, then to number 2, then to letter B, then to number 3, then to letter C then so forth until they connected the circles as quickly as possible, without lifting pen or pencil from the paper. Participant was timed (maximum time limit was 300 seconds or 5 minutes) to connect the "trail." If the participant made an error, and it was pointed out immediately, the participant was allowed to correct it. Errors affected the participant's score only in that the correction of errors was included in the completion time for the task. A higher number of errors was indicative of a higher cognitive deficit. Raw results were the number of seconds required to complete the task; therefore, higher scores reveal greater impairment. Raw results based on age norms were transformed to Z-scores. Z-score = actual value minus normative value divided by standard deviation.	Baseline, Month 18
Change From Baseline in Cognitive Function Using Trails B at Month 24	Trail B test is a set of shifting task, in which participants were asked to drawn a line from number 1 to letter A, then to number 2, then to letter B, then to number 3, then to letter C then so forth until they connected the circles as quickly as possible, without lifting pen or pencil from the paper. Participant was timed (maximum time limit was 300 seconds or 5 minutes) to connect the "trail." If the participant made an error, and it was pointed out immediately, the participant was allowed to correct it. Errors affected the participant's score only in that the correction of errors was included in the completion time for the task. A higher number of errors was indicative of a higher cognitive deficit. Raw results were the number of seconds required to complete the task; therefore, higher scores reveal greater impairment. Raw results based on age norms were transformed to Z-scores. Z-score = actual value minus normative value divided by standard deviation.	Baseline, Month 24
Change From Baseline in Cognitive Function Using Trails B at Month 30	Trail B test is a set of shifting task, in which participants were asked to drawn a line from number 1 to letter A, then to number 2, then to letter B, then to number 3, then to letter C then so forth until they connected the circles as quickly as possible, without lifting pen or pencil from the paper. Participant was timed (maximum time limit was 300 seconds or 5 minutes) to connect the "trail." If the participant made an error, and it was pointed out immediately, the participant was allowed to correct it. Errors affected the participant's score only in that the correction of errors was included in the completion time for the task. A higher number of errors was indicative of a higher cognitive deficit. Raw results were the number of seconds required to complete the task; therefore, higher scores reveal greater impairment. Raw results based on age norms were transformed to Z-scores. Z-score = actual value minus normative value divided by standard deviation.	Baseline, Month 30
Change From Baseline in Cognitive Function Using Trails B at Month 36	Trail B test is a set of shifting task, in which participants were asked to drawn a line from number 1 to letter A, then to number 2, then to letter B, then to number 3, then to letter C then so forth until they connected the circles as quickly as possible, without lifting pen or pencil from the paper. Participant was timed (maximum time limit was 300 seconds or 5 minutes) to connect the "trail." If the participant made an error, and it was pointed out immediately, the participant was allowed to correct it. Errors affected the participant's score only in that the correction of errors was included in the completion time for the task. A higher number of errors was indicative of a higher cognitive deficit. Raw results were the number of seconds required to complete the task; therefore, higher scores reveal greater impairment. Raw results based on age norms were transformed to Z-scores. Z-score = actual value minus normative value divided by standard deviation.	Baseline, Month 36
Change From Baseline in Cognitive Function Using Metacognition Index From Behavior Rating Inventory of Executive Function (BRIEF) at Month 3	BRIEF has 86-items to measure the neurocognitive performance for 8 subscales: inhibit, shift, emotional control, initiate, working memory, plan-organize, organization of materials and monitor. These are subsumed in 2 broad factors: a behavior regulation index consisted inhibit, shift, and emotional control subscales, a metacognition index consisted working memory, initiate, plan/organize, organization of materials, and task-monitor scale. Each item had a 3-point scale (1= never, 2= sometimes, 3= often). Z-score was based on mean raw score for T-score= 50 and SD = +/- 10. (actual value raw score at T=50)/SD (mean SD where T=40,60), based on age and gender norms from BRIEF professional manual. T-score provided information of individual's scores relative to scores of respondents in the standardization sample. Lower Z- scores indicated better functioning.	Baseline, Month 3
Change From Baseline in Cognitive Function Using Metacognition Index From Behavior Rating Inventory of Executive Function (BRIEF) at Month 6	BRIEF has 86-items to measure the neurocognitive performance for 8 subscales: inhibit, shift, emotional control, initiate, working memory, plan-organize, organization of materials and monitor. These are subsumed in 2 broad factors: a behavior regulation index consisted inhibit, shift, and emotional control subscales, a metacognition index consisted working memory, initiate, plan/organize, organization of materials, and task-monitor scale. Each item had a 3-point scale (1= never, 2= sometimes, 3= often). Z-score was based on mean raw score for T-score= 50 and SD = +/- 10. (actual value raw score at T=50)/SD (mean SD where T=40,60), based on age and gender norms from BRIEF professional manual. T-score provided information of individual's scores relative to scores of respondents in the standardization sample. Lower Z- scores indicated better functioning.	Baseline, Month 6
Change From Baseline in Cognitive Function Using Metacognition Index From Behavior Rating Inventory of Executive Function (BRIEF) at Month 12	BRIEF has 86-items to measure the neurocognitive performance for 8 subscales: inhibit, shift, emotional control, initiate, working memory, plan-organize, organization of materials and monitor. These are subsumed in 2 broad factors: a behavior regulation index consisted inhibit, shift, and emotional control subscales, a metacognition index consisted working memory, initiate, plan/organize, organization of materials, and task-monitor scale. Each item had a 3-point scale (1= never, 2= sometimes, 3= often). Z-score was based on mean raw score for T-score= 50 and SD = +/- 10. (actual value raw score at T=50)/SD (mean SD where T=40,60), based on age and gender norms from BRIEF professional manual. T-score provided information of individual's scores relative to scores of respondents in the standardization sample. Lower Z- scores indicated better functioning.	Baseline, Month 12
Change From Baseline in Cognitive Function Using Metacognition Index From Behavior Rating Inventory of Executive Function (BRIEF) at Month 18	BRIEF has 86-items to measure the neurocognitive performance for 8 subscales: inhibit, shift, emotional control, initiate, working memory, plan-organize, organization of materials and monitor. These are subsumed in 2 broad factors: a behavior regulation index consisted inhibit, shift, and emotional control subscales, a metacognition index consisted working memory, initiate, plan/organize, organization of materials, and task-monitor scale. Each item had a 3-point scale (1= never, 2= sometimes, 3= often). Z-score was based on mean raw score for T-score= 50 and SD = +/- 10. (actual value raw score at T=50)/SD (mean SD where T=40,60), based on age and gender norms from BRIEF professional manual. T-score provided information of individual's scores relative to scores of respondents in the standardization sample. Lower Z- scores indicated better functioning.	Baseline, Month 18
Change From Baseline in Cognitive Function Using Metacognition Index From Behavior Rating Inventory of Executive Function (BRIEF) at Month 24	BRIEF has 86-items to measure the neurocognitive performance for 8 subscales: inhibit, shift, emotional control, initiate, working memory, plan-organize, organization of materials and monitor. These are subsumed in 2 broad factors: a behavior regulation index consisted inhibit, shift, and emotional control subscales, a metacognition index consisted working memory, initiate, plan/organize, organization of materials, and task-monitor scale. Each item had a 3-point scale (1= never, 2= sometimes, 3= often). Z-score was based on mean raw score for T-score= 50 and SD = +/- 10. (actual value raw score at T=50)/SD (mean SD where T=40,60), based on age and gender norms from BRIEF professional manual. T-score provided information of individual's scores relative to scores of respondents in the standardization sample. Lower Z- scores indicated better functioning.	Baseline, Month 24
Change From Baseline in Cognitive Function Using Metacognition Index From Behavior Rating Inventory of Executive Function (BRIEF) at Month 30	BRIEF has 86-items to measure the neurocognitive performance for 8 subscales: inhibit, shift, emotional control, initiate, working memory, plan-organize, organization of materials and monitor. These are subsumed in 2 broad factors: a behavior regulation index consisted inhibit, shift, and emotional control subscales, a metacognition index consisted working memory, initiate, plan/organize, organization of materials, and task-monitor scale. Each item had a 3-point scale (1= never, 2= sometimes, 3= often). Z-score was based on mean raw score for T-score= 50 and SD = +/- 10. (actual value raw score at T=50)/SD (mean SD where T=40,60), based on age and gender norms from BRIEF professional manual. T-score provided information of individual's scores relative to scores of respondents in the standardization sample. Lower Z- scores indicated better functioning.	Baseline, Month 30
Change From Baseline in Cognitive Function Using Metacognition Index From Behavior Rating Inventory of Executive Function (BRIEF) at Month 36	BRIEF has 86-items to measure the neurocognitive performance for 8 subscales: inhibit, shift, emotional control, initiate, working memory, plan-organize, organization of materials and monitor. These are subsumed in 2 broad factors: a behavior regulation index consisted inhibit, shift, and emotional control subscales, a metacognition index consisted working memory, initiate, plan/organize, organization of materials, and task-monitor scale. Each item had a 3-point scale (1= never, 2= sometimes, 3= often). Z-score was based on mean raw score for T-score= 50 and SD = +/- 10. (actual value raw score at T=50)/SD (mean SD where T=40,60), based on age and gender norms from BRIEF professional manual. T-score provided information of individual's scores relative to scores of respondents in the standardization sample. Lower Z- scores indicated better functioning.	Baseline, Month 36
Change From Baseline in Behavioral/Emotional Regulation Using the Behavior Regulation Index From BRIEF at Month 3	BRIEF has 86-items to measure the neurocognitive performance for 8 subscales: inhibit, shift, emotional control, initiate, working memory, plan-organize, organization of materials and monitor. These are subsumed in 2 broad factors: a behavior regulation index consisted inhibit, shift, and emotional control subscales, a metacognition index consisted working memory, initiate, plan/organize, organization of materials, and task-monitor scale. Each item had a 3-point scale (1= never, 2= sometimes, 3= often). Z-score was based on mean raw score for T-score= 50 and SD = +/- 10. (actual value raw score at T=50)/SD (mean SD where T=40,60), based on age and gender norms from BRIEF professional manual. T-score provided information of individual's scores relative to scores of respondents in the standardization sample. Lower Z- scores indicated better functioning.	Baseline, Month 3
Change From Baseline in Behavioral/Emotional Regulation Using the Behavior Regulation Index From BRIEF at Month 6	BRIEF has 86-items to measure the neurocognitive performance for 8 subscales: inhibit, shift, emotional control, initiate, working memory, plan-organize, organization of materials and monitor. These are subsumed in 2 broad factors: a behavior regulation index consisted inhibit, shift, and emotional control subscales, a metacognition index consisted working memory, initiate, plan/organize, organization of materials, and task-monitor scale. Each item had a 3-point scale (1= never, 2= sometimes, 3= often). Z-score was based on mean raw score for T-score= 50 and SD = +/- 10. (actual value raw score at T=50)/SD (mean SD where T=40,60), based on age and gender norms from BRIEF professional manual. T-score provided information of individual's scores relative to scores of respondents in the standardization sample. Lower Z- scores indicated better functioning.	Baseline, Month 6
Change From Baseline in Behavioral/Emotional Regulation Using the Behavior Regulation Index From BRIEF at Month 12	BRIEF has 86-items to measure the neurocognitive performance for 8 subscales: inhibit, shift, emotional control, initiate, working memory, plan-organize, organization of materials and monitor. These are subsumed in 2 broad factors: a behavior regulation index consisted inhibit, shift, and emotional control subscales, a metacognition index consisted working memory, initiate, plan/organize, organization of materials, and task-monitor scale. Each item had a 3-point scale (1= never, 2= sometimes, 3= often). Z-score was based on mean raw score for T-score= 50 and SD = +/- 10. (actual value raw score at T=50)/SD (mean SD where T=40,60), based on age and gender norms from BRIEF professional manual. T-score provided information of individual's scores relative to scores of respondents in the standardization sample. Lower Z- scores indicated better functioning.	Baseline, Month 12
Change From Baseline in Behavioral/Emotional Regulation Using the Behavior Regulation Index From BRIEF at Month 18	BRIEF has 86-items to measure the neurocognitive performance for 8 subscales: inhibit, shift, emotional control, initiate, working memory, plan-organize, organization of materials and monitor. These are subsumed in 2 broad factors: a behavior regulation index consisted inhibit, shift, and emotional control subscales, a metacognition index consisted working memory, initiate, plan/organize, organization of materials, and task-monitor scale. Each item had a 3-point scale (1= never, 2= sometimes, 3= often). Z-score was based on mean raw score for T-score= 50 and SD = +/- 10. (actual value raw score at T=50)/SD (mean SD where T=40,60), based on age and gender norms from BRIEF professional manual. T-score provided information of individual's scores relative to scores of respondents in the standardization sample. Lower Z- scores indicated better functioning.	Baseline, Month 18
Change From Baseline in Behavioral/Emotional Regulation Using the Behavior Regulation Index From BRIEF at Month 24	BRIEF has 86-items to measure the neurocognitive performance for 8 subscales: inhibit, shift, emotional control, initiate, working memory, plan-organize, organization of materials and monitor. These are subsumed in 2 broad factors: a behavior regulation index consisted inhibit, shift, and emotional control subscales, a metacognition index consisted working memory, initiate, plan/organize, organization of materials, and task-monitor scale. Each item had a 3-point scale (1= never, 2= sometimes, 3= often). Z-score was based on mean raw score for T-score= 50 and SD = +/- 10. (actual value raw score at T=50)/SD (mean SD where T=40,60), based on age and gender norms from BRIEF professional manual. T-score provided information of individual's scores relative to scores of respondents in the standardization sample. Lower Z- scores indicated better functioning.	Baseline, Month 24
Change From Baseline in Behavioral/Emotional Regulation Using the Behavior Regulation Index From BRIEF at Month 30	BRIEF has 86-items to measure the neurocognitive performance for 8 subscales: inhibit, shift, emotional control, initiate, working memory, plan-organize, organization of materials and monitor. These are subsumed in 2 broad factors: a behavior regulation index consisted inhibit, shift, and emotional control subscales, a metacognition index consisted working memory, initiate, plan/organize, organization of materials, and task-monitor scale. Each item had a 3-point scale (1= never, 2= sometimes, 3= often). Z-score was based on mean raw score for T-score= 50 and SD = +/- 10. (actual value raw score at T=50)/SD (mean SD where T=40,60), based on age and gender norms from BRIEF professional manual. T-score provided information of individual's scores relative to scores of respondents in the standardization sample. Lower Z- scores indicated better functioning.	Baseline, Month 30
Change From Baseline in Behavioral/Emotional Regulation Using the Behavior Regulation Index From BRIEF at Month 36	BRIEF has 86-items to measure the neurocognitive performance for 8 subscales: inhibit, shift, emotional control, initiate, working memory, plan-organize, organization of materials and monitor. These are subsumed in 2 broad factors: a behavior regulation index consisted inhibit, shift, and emotional control subscales, a metacognition index consisted working memory, initiate, plan/organize, organization of materials, and task-monitor scale. Each item had a 3-point scale (1= never, 2= sometimes, 3= often). Z-score was based on mean raw score for T-score= 50 and SD = +/- 10. (actual value raw score at T=50)/SD (mean SD where T=40,60), based on age and gender norms from BRIEF professional manual. T-score provided information of individual's scores relative to scores of respondents in the standardization sample. Lower Z- scores indicated better functioning.	Baseline, Month 36
Change From Baseline in Height at Month 3	Height was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw height measurements were norm-adjusted transformed to Z-score using formula: Z-score= actual value minus normative value divided by standard deviation based on centers for disease control (CDC) norms for age and gender.	Baseline, Month 3
Change From Baseline in Height at Month 6	Height was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw height measurements were norm-adjusted transformed to Z-score using formula: Z-score= actual value minus normative value divided by standard deviation based on CDC norms for age and gender.	Baseline, Month 6
Change From Baseline in Height at Month 12	Height was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw height measurements were norm-adjusted transformed to Z-score using formula: Z-score= actual value minus normative value divided by standard deviation based on CDC norms for age and gender.	Baseline, Month 12
Change From Baseline in Height at Month 18	Height was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw height measurements were norm-adjusted transformed to Z-score using formula: Z-score= actual value minus normative value divided by standard deviation based on CDC norms for age and gender.	Baseline, Month 18
Change From Baseline in Height at Month 24	Height was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw height measurements were norm-adjusted transformed to Z-score using formula: Z-score= actual value minus normative value divided by standard deviation based on CDC norms for age and gender.	Baseline, Month 24
Change From Baseline in Height at Month 30	Height was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw height measurements were norm-adjusted transformed to Z-score using formula: Z-score= actual value minus normative value divided by standard deviation based on CDC norms for age and gender.	Baseline, Month 30
Change From Baseline in Height at Month 36	Height was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw height measurements were norm-adjusted transformed to Z-score using formula: Z-score= actual value minus normative value divided by standard deviation based on CDC norms for age and gender.	Baseline, Month 36
Change From Baseline in Weight at Month 3	Weight was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw weight measurements were norm-adjusted transformed to Z-score using formula: Z-score= actual value minus normative value divided by standard deviation based on CDC norms for age and gender.	Baseline, Month 3
Change From Baseline in Weight at Month 6	Weight was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw weight measurements were norm-adjusted transformed to Z-score using formula: Z-score= actual value minus normative value divided by standard deviation based on CDC norms for age and gender.	Baseline, Month 6
Change From Baseline in Weight at Month 12	Weight was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw weight measurements were norm-adjusted transformed to Z-score using formula: Z-score= actual value minus normative value divided by standard deviation based on CDC norms for age and gender.	Baseline, Month 12
Change From Baseline in Weight at Month 18	Weight was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw weight measurements were norm-adjusted transformed to Z-score using formula: Z-score= actual value minus normative value divided by standard deviation based on CDC norms for age and gender.	Baseline, Month 18
Change From Baseline in Weight at Month 24	Weight was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw weight measurements were norm-adjusted transformed to Z-score using formula: Z-score= actual value minus normative value divided by standard deviation based on CDC norms for age and gender.	Baseline, Month 24
Change From Baseline in Weight at Month 30	Weight was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw weight measurements were norm-adjusted transformed to Z-score using formula: Z-score= actual value minus normative value divided by standard deviation based on CDC norms for age and gender.	Baseline, Month 30
Change From Baseline in Weight at Month 36	Weight was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw weight measurements were norm-adjusted transformed to Z-score using formula: Z-score= actual value minus normative value divided by standard deviation based on CDC norms for age and gender.	Baseline, Month 36
Change From Baseline in Body Mass Index (BMI) at Month 3	BMI is participant's weight in kilograms divided by the square of height in meters. BMI was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw BMI measurements were norm-adjusted transformed to Z-score using formula: Z-score = actual value minus normative value divided by standard deviation based on CDC norms for age and gender.	Baseline, Month 3
Change From Baseline in Body Mass Index (BMI) at Month 6	BMI is participant's weight in kilograms divided by the square of height in meters. BMI was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw BMI measurements were norm-adjusted transformed to Z-score using formula: Z-score = actual value minus normative value divided by standard deviation based on CDC norms for age and gender.	Baseline, Month 6
Change From Baseline in Body Mass Index (BMI) at Month 12	BMI is participant's weight in kilograms divided by the square of height in meters. BMI was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw BMI measurements were norm-adjusted transformed to Z-score using formula: Z-score = actual value minus normative value divided by standard deviation based on CDC norms for age and gender.	Baseline, Month 12
Change From Baseline in Body Mass Index (BMI) at Month 18	BMI is participant's weight in kilograms divided by the square of height in meters. BMI was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw BMI measurements were norm-adjusted transformed to Z-score using formula: Z-score = actual value minus normative value divided by standard deviation based on CDC norms for age and gender.	Baseline, Month 18
Change From Baseline in Body Mass Index (BMI) at Month 24	BMI is participant's weight in kilograms divided by the square of height in meters. BMI was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw BMI measurements were norm-adjusted transformed to Z-score using formula: Z-score = actual value minus normative value divided by standard deviation based on CDC norms for age and gender.	Baseline, Month 24
Change From Baseline in Body Mass Index (BMI) at Month 30	BMI is participant's weight in kilograms divided by the square of height in meters. BMI was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw BMI measurements were norm-adjusted transformed to Z-score using formula: Z-score = actual value minus normative value divided by standard deviation based on CDC norms for age and gender.	Baseline, Month 30
Change From Baseline in Body Mass Index (BMI) at Month 36	BMI is participant's weight in kilograms divided by the square of height in meters. BMI was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw BMI measurements were norm-adjusted transformed to Z-score using formula: Z-score = actual value minus normative value divided by standard deviation based on CDC norms for age and gender.	Baseline, Month 36
Primary: Number of Participants With Tanner Staging Evaluation at Baseline: All Males	Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. The physical changes for males in pubertal development (pubic hair, penis and testes) were assessed. Participants were evaluated for genital development, with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics).	Baseline (prior to or within 45 Days of initiating treatment, if exposed) and after parental/guardian provided permission and assent
Number of Participants With Tanner Staging Evaluation at Month 3: All Males	Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. The physical changes for males in pubertal development (pubic hair, penis and testes) were assessed. Participants were evaluated for genital development, with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics).	Month 3
Number of Participants With Tanner Staging Evaluation at Month 6: All Males	Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. The physical changes for males in pubertal development (pubic hair, penis and testes) were assessed. Participants were evaluated for genital development, with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics).	Month 6
Number of Participants With Tanner Staging Evaluation at Month 12: All Males	Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. The physical changes for males in pubertal development (pubic hair, penis and testes) were assessed. Participants were evaluated for genital development, with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics).	Month 12
Number of Participants With Tanner Staging Evaluation at Month 18: All Males	Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. The physical changes for males in pubertal development (pubic hair, penis and testes) were assessed. Participants were evaluated for genital development, with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics).	Month 18
Number of Participants With Tanner Staging Evaluation at Month 24: All Males	Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. The physical changes for males in pubertal development (pubic hair, penis and testes) were assessed. Participants were evaluated for genital development, with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics).	Month 24
Number of Participants With Tanner Staging Evaluation at Month 30: All Males	Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. The physical changes for males in pubertal development (pubic hair, penis and testes) were assessed. Participants were evaluated for genital development, with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics).	Month 30
Number of Participants With Tanner Staging Evaluation at Month 36: All Males	Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. The physical changes for males in pubertal development (pubic hair, penis and testes) were assessed. Participants were evaluated for genital development, with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics).	Month 36
Number of Participants With Tanner Staging Evaluation at Baseline: All Females	Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. The physical changes for females in pubertal development were assessed. Participants were evaluated for pubic hair distribution, breast development, with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics).	Baseline (prior to or within 45 Days of initiating treatment, if exposed) and after parental/guardian provided permission and assent
Number of Participants With Tanner Staging Evaluation at Month 3: All Females	Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. The physical changes for females in pubertal development were assessed. Participants were evaluated for pubic hair distribution, breast development, with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics).	Month 3
Number of Participants With Tanner Staging Evaluation at Month 6: All Females	Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. The physical changes for females in pubertal development were assessed. Participants were evaluated for pubic hair distribution, breast development, with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics).	Month 6
Number of Participants With Tanner Staging Evaluation at Month 12: All Females	Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. The physical changes for females in pubertal development were assessed. Participants were evaluated for pubic hair distribution, breast development, with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics).	Month 12
Number of Participants With Tanner Staging Evaluation at Month 18: All Females	Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. The physical changes for females in pubertal development were assessed. Participants were evaluated for pubic hair distribution, breast development, with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics).	Month 18
Number of Participants With Tanner Staging Evaluation at Month 24: All Females	Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. The physical changes for females in pubertal development were assessed. Participants were evaluated for pubic hair distribution, breast development, with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics).	Month 24
Number of Participants With Tanner Staging Evaluation at Month 30: All Females	Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. The physical changes for females in pubertal development were assessed. Participants were evaluated for pubic hair distribution, breast development, with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics).	Month 30
Number of Participants With Tanner Staging Evaluation at Month 36: All Females	Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. The physical changes for females in pubertal development were assessed. Participants were evaluated for pubic hair distribution, breast development, with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics).	Month 36

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36	CGI-I scale was a 7-point scale used to rate improvement in the participant's condition (benefits). Scale range/categories: 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = Not changed, 5 = minimally worse, 6 = much worse, and 7 = very much worse. Higher score indicated worse condition.	Month 3, 6, 12, 18, 24, 30 and 36
Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36	CGI-T scale was a 7-point scale used to assess the tolerability of the study medication with respect to adverse events. Scale range/categories: 1= very high, 2= high, 3= above average, 4= average, 5= low, 6= very low, and 7= extremely low. Higher score indicated less tolerability with study medication.	Month 3, 6, 12, 18, 24, 30 and 36
Number of Participants Who Were Responders According to Clinical Global Impression-Effectiveness (CGI-E) Scale at Month 3, 6, 12, 18, 24, 30 and 36	The CGI-E was the value at which the participant's therapeutic benefit and adverse impact to the study drug intersected. Firstly clinician identified the degree of therapeutic benefit on scale range: very much improved, much improved, minimally improved, unchanged or worse. Secondly, the clinician rater identified the degree to which problems with tolerability adversely impact the participant on scale range: no adverse impact, mild adverse impact, moderate adverse impact, outweighs therapeutic effect. Finally, clinician identified in which participants benefits and adverse impacts intersected. Participants were then determined to be responders or non-responders to the study medication.	Month 3, 6, 12, 18, 24, 30 and 36
Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36	CGI-S scale was a 7-point scale used to assess severity of illness on a range of 1 to 7; where, 1= normal, not mentally ill, 2= borderline mentally ill, 3= mildly mentally ill, 4= moderately mentally ill, 5= markedly mentally ill, 6= severely mentally ill, and 7= among the most extremely mentally. Higher score indicated worse condition.	Baseline, Month 3, 6, 12, 18, 24, 30 and 36
Change From Baseline in Child Global Assessment Scale (CGAS) at Month 3, 6, 12, 18, 24, 30 and 36	CGAS was to rate the general functioning of the study participants on a numeric scale of 1 to 100, where 1= extremely impaired and 100= doing very well.	Baseline, Month 3, 6, 12, 18, 24, 30 and 36
Change From Baseline in General Health and Social Functioning Using the Health of the Nation Outcome Scale for Children and Adolescents (HoNOSCA) Total Score at Month 3, 6, 12, 18, 24, 30 and 36	HoNOSCA scale had 13-sub-scales used to assess general health and social functioning. 13 sub-scales were as the following: disruptive or aggressive behavior, attention deficit hyperactivity disorder (ADHD), self-harm, substance abuse, school problems, physical illness, psychosis, physical symptoms, internalizing symptoms, peer relationships, self-care, family relationships and school attendance problems. Each sub-scale had a range of 0 (no problems) to 4 (severe problems). Scores from all 13 sub-scales were summed up to give overall possible HoNOSCA total score range of 0 to 52. Higher score indicated worse condition.	Baseline, Month 3, 6, 12, 18, 24, 30 and 36

Collaborators and Investigators

• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Publications and helpful links

General Publications

• Kolitsopoulos F, Ramaker S, Compton S, Broderick S, Orazem J, Bao W, Lokhnygina Y, Chappell P. Sertraline Pediatric Registry for the Evaluation of Safety: Design and Clinical Characteristics of Pediatric Patients Prescribed Sertraline. J Child Adolesc Psychopharmacol. 2021 Aug;31(6):411-420. doi: 10.1089/cap.2020.0170. Epub 2021 Jul 21.

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): April 4, 2012
• Primary Completion (Actual): September 9, 2020
• Study Completion (Actual): September 9, 2020

Study Registration Dates

• First Submitted: February 1, 2011
• First Submitted That Met QC Criteria: February 18, 2011
• First Posted (Estimate): February 23, 2011

Study Record Updates

• Last Update Posted (Actual): October 14, 2021
• Last Update Submitted That Met QC Criteria: October 12, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: cognition; sertraline; cohort; prospective; long-term impact; emotional and physical development; pubertal maturation
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders; Obsessive-Compulsive Disorder; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Sertraline
• Other Study ID Numbers: A0501093; SPRITES (Other Identifier: Alias Study Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.