Second-Generation Antipsychotic Treatment Indication Effectiveness And Tolerability In Youth (Satiety) Study (SATIETY)

The purpose of this study is to get a better understanding of the side effect burden and identify predictors of psychotic, mood and aggressive disorders in children and adolescents. The study's primary aim is to identify genetic risk factors for weight gain and metabolic abnormalities.

Study Overview

• Status: Completed
• Conditions: Schizophrenia; Schizoaffective Disorder; Schizophreniform Disorder; Bipolar Disorder; Autism Spectrum Disorder; Major Depressive Disorder; Prodromal Schizophrenia; Mood Disorder; Psychotic Disorder, Not Otherwise Specified; Depressive Disorder, Not Otherwise Specified; Mood Disorder, Not Otherwise Specified

Detailed Description

Participants will be evaluated for biological and genetic risk factors for nutritional and metabolic adverse effects associated with SGAPs (second generation antipsychotics) during 4 visits over 12 weeks. Participants will also be evaluated at month 6, 9, and 12. This study does not involve treatment for participants. Treatment of subjects enrolled in this study will be determined by their clinician and will remain unaffected by participation in this observational minimal risk study.

All participants were prescribed risperidone (Risperdal) for the duration of study participation and doses ranged from 0.25mg to 6mg daily for 52 weeks.

• Study Type: Observational
• Enrollment (Actual): 4

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27514
      • University of North Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 19 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The investigators aim to recruit 200 individuals between the ages of 3 and 19, from a diverse range of ethnic and racial backgrounds, who have a clinical diagnosis of psychotic disorders, mood disorder or an autism spectrum disorder and are considered for treatment with second generation antipsychotic (SGAP) medication by a physician.

Every effort will be made to recruit participants of all ethnicities, races and genders. The investigators will specifically target recruitment efforts toward minorities by using minority media and informational liaison with community organizations that serve minority populations.

Description

Inclusion Criteria:

1. Patients between the ages of 3 and 19 (at the time of consent)
2. Clinical diagnosis of psychotic disorders (i.e., schizophrenia, schizoaffective disorder, schizophreniform disorder, psychotic disorder not otherwise specified and prodromal schizophrenia (as defined by the Scale of Prodromal Symptoms (SOPS: Miller 1996)), mood disorder (i.e., bipolar disorder, major depressive disorder, depressive disorder not otherwise specified, mood disorder not otherwise specified) or an autism spectrum disorder.
3. Subjects who are considered for treatment with second generation antipsychotics (SGAPs) by a physician who has evaluated him/her
4. Subjects who are either A) antipsychotic naïve and have started an SGA within the past 2 weeks , B) have started a new antipsychotic within the past 2 weeks (specifically within 2 weeks of their first blood draw), or

Exclusion Criteria:

1. Individuals younger than 3 years or older than 19 years and 11 months (at the time of consent)
2. Personal history of or comorbid eating disorders
3. Active hyper-/hypothyroidism
4. Pregnancy
5. Severe medical disorder (i.e., AIDS, cancer, sepsis, etc.).

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Weight (in Lbs.)	Participants will be evaluated for biological and genetic risk factors for nutritional and metabolic adverse effects associated with second-generation antipsychotics (SGA's) during 4 visits over 12 weeks. Participants will also be evaluated at Month 6, 9, and 12 (Week 52). Since only a single participant finished the study and had assessments through Week 52, we compiled the data from all subject endpoints (1 Week 12 visit, 2 Week 36 visits, and 1 Week 52 visit) and this is the data reported below.	Baseline and 52 Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Glucose Levels (mg/dL)	Participants will be evaluated for biological and genetic risk factors for nutritional and metabolic adverse effects associated with second-generation antipsychotics (SGA's) during 4 visits over 12 weeks. Participants will also be evaluated at Month 6, 9, and 12 (Week 52). Since only a single participant finished the study and had assessments through Week 52, we compiled the data from all subject endpoints (1 Week 12 visit, 2 Week 36 visits, and 1 Week 52 visit) and this is the data reported below.	Baseline and 52 Weeks
Change in Total Cholesterol (mg/dL)	Participants will be evaluated for biological and genetic risk factors for nutritional and metabolic adverse effects associated with second-generation antipsychotics (SGA's) during 4 visits over 12 weeks. Participants will also be evaluated at Month 6, 9, and 12 (Week 52). Since only a single participant finished the study and had assessments through Week 52, we compiled the data from all subject endpoints (1 Week 12 visit, 2 Week 36 visits, and 1 Week 52 visit) and this is the data reported below.	Baseline and 52 Weeks
Change in Triglycerides (mg/dL)	Participants will be evaluated for biological and genetic risk factors for nutritional and metabolic adverse effects associated with second-generation antipsychotics (SGA's) during 4 visits over 12 weeks. Participants will also be evaluated at Month 6, 9, and 12 (Week 52). Since only a single participant finished the study and had assessments through Week 52, we compiled the data from all subject endpoints (1 Week 12 visit, 2 Week 36 visits, and 1 Week 52 visit) and this is the data reported below.	Baseline and 52 Weeks
Change in LDL (mg/dL)	Participants will be evaluated for biological and genetic risk factors for nutritional and metabolic adverse effects associated with second-generation antipsychotics (SGA's) during 4 visits over 12 weeks. Participants will also be evaluated at Month 6, 9, and 12 (Week 52). Since only a single participant finished the study and had assessments through Week 52, we compiled the data from all subject endpoints (1 Week 12 visit, 2 Week 36 visits, and 1 Week 52 visit) and this is the data reported below.	Baseline and 52 Weeks

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (Actual): March 1, 2011
• Study Completion (Actual): March 1, 2011

Study Registration Dates

• First Submitted: January 3, 2011
• First Submitted That Met QC Criteria: January 3, 2011
• First Posted (Estimate): January 4, 2011

Study Record Updates

• Last Update Posted (Estimate): February 22, 2013
• Last Update Submitted That Met QC Criteria: January 18, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Keywords: Schizophrenia; Mood Disorders; Autism; Schizoaffective; Schizophreniform; Weight; Psychosis NOS; Second Generation Antipsychotics
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Pathologic Processes; Schizophrenia Spectrum and Other Psychotic Disorders; Bipolar and Related Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Depression; Depressive Disorder; Schizophrenia; Disease; Psychotic Disorders; Bipolar Disorder; Mood Disorders; Autism Spectrum Disorder; Depressive Disorder, Major
• Other Study ID Numbers: 09-1734