- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00078767
Pharmacologic Treatment of PTSD in Sexually Abused Children
April 3, 2017 updated by: Judith Cohen, Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
This study will evaluate the benefit of adding sertraline (Zoloft®) to Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) for sexually abused children who have Posttraumatic Stress Disorder (PTSD).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Adult research has demonstrated the efficacy of selective serotonin reuptake inhibitors (SSRIs) in decreasing Posttraumatic Stress Disorder (PTSD) symptoms; to date the SSRIs are the only medication class with demonstrated efficacy in treating all three PTSD symptom clusters (reexperiencing, avoidance, and hyperarousal).
No studies have evaluated the impact of SSRIs on PTSD symptoms in children or adolescents.
Trauma-focused CBT has been shown in several studies to be efficacious in decreasing PTSD symptoms in sexually abused children and adolescents.
Many children and youth with PTSD are currently prescribed SSRIs and other medications.
This study will evaluate whether adding the SSRI sertraline provides additional benefits over TF-CBT treatment for sexually abused children and adolescents with PTSD.
If adequate numbers of children with comorbid PTSD and depressive and/or anxiety disorders are included, it may also be possible to evaluate whether any benefit of adding sertraline is restricted to those children with comorbid disorders.
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15212
- Allegheny General Hospital Center for Traumatic Stress in Children and Adolescents
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
10 years to 17 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion:
- Ages 10-17 years, inclusive
- Confirmed sexual abuse
- At least 5 PTSD symptoms on KSADS-PL, with at least one symptom in each of 3 symptom clusters (reexperiencing, avoidance, arousal)
- Parent/primary caregiver available to participate in treatment
- Assent with parental consent to participate
Exclusion:
- Non-English speaking
- schizophrenia or other severe psychotic disorder
- MR (IQ<60) or PDD preventing CBT treatment
- taking current psychotropic medication
- documented substance dependence (substance abuse allowed)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: TF-CBT + sertraline
Trauma-Focused CBT provided individually to youth and parent for 12 sessions (90 minute sessions; 45 minutes for youth; 45 minutes for parent); plus Sertraline provided in dosage titrated as clinically indicated by child psychiatrist blind to treatment assignment, from 50mg/day to a maximum dosage of 150 mg/day
|
12 weeks of Trauma-Focused CBT (TF-CBT)for youth and parent
12 weeks of Sertraline pill, flexible dosage of 50-150 mg/day, to be administered while receiving TF-CBT
|
Active Comparator: TF-CBT +placebo
Trauma-Focused CBT provided individually to youth and parent for 12 sessions (90 minute sessions; 45 minutes for youth; 45 minutes for parent); plus placebo identical to Sertraline, provided in pill form and titrated as clinically indicated by child psychiatrist blind to treatment assignment, from 1 to 3 pills/day (identical in appearance to 50 to 150mg/day of Sertraline)
|
12 weeks of Sertraline pill, flexible dosage of 50-150 mg/day, to be administered while receiving TF-CBT
12 weeks of Placebo pill, flexible dosage, of 50-150 mg/day, to be administered while receiving TF-CBT
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Kiddie-Sads-Present and Lifetime (KSADS-PL) Scale for PTSD
Time Frame: Up to 39 months
|
Change in PTSD parameters as determined by changes in score.
At enrollment, participants either did or did not have a PTSD diagnosis.
The three categories displayed show participants who had the PTSD diagnosis at the time of enrollment but did have evidence of PTSD at the end of their participation, participants who had PTSD at enrollment and who continued to exhibit PTSD at the end of their participation, and those who did not have a PTSD diagnosis at the start of the trial.
There are numerous criteria used to determine a PTSD diagnosis; they are not individually listed.
The diagnosis was sufficient for the purposes of the study.
|
Up to 39 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mood and Feelings Questionnaire (MFQ) for Depressive Symptoms
Time Frame: Up to 39 months
|
Change in depressive symptoms as determined by change in score
|
Up to 39 months
|
Anxiety Symptoms
Time Frame: Up to 39 months
|
Change in SCARED scores between treatment groups.There were two categories of depression: participants that had clinical signs of depression at the time of enrollment, and participants that did not have clinical signs of depression.
Participants in the "clinical symptom present at enrollment" category were tested to see if their status changed during the trial.
|
Up to 39 months
|
Global Impairment
Time Frame: Up to 39 months
|
Change in Children's Global Assessment Scale (CGAS) between the two groups
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Up to 39 months
|
Incidence of Suicidality
Time Frame: Up to 39 months
|
Change in degree of suicidal ideation during study
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Up to 39 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Judith A Cohen, M.D., Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2001
Primary Completion (Actual)
March 1, 2006
Study Completion (Actual)
March 1, 2006
Study Registration Dates
First Submitted
March 5, 2004
First Submitted That Met QC Criteria
March 5, 2004
First Posted (Estimate)
March 8, 2004
Study Record Updates
Last Update Posted (Actual)
April 5, 2017
Last Update Submitted That Met QC Criteria
April 3, 2017
Last Verified
April 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Trauma and Stressor Related Disorders
- Stress Disorders, Traumatic
- Stress Disorders, Post-Traumatic
- 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
- K02MH001938 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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