NCT00078767|CompletedPhase 3ResultsDMC
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Sponsor study identifier
NIH
Secondary identifiers
NIH
interventional
24
1 country
1
Study Start
April 2001
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
March 2006
Actual (reported)Study Completion
March 2006
Actual (reported)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).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2006
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 2001
Date type not reportedThis date has not been verified as actual or estimated.
March 5, 2004
Actual (reported)March 8, 2004
Actual (reported)March 2006
Actual (reported)March 2006
Actual (reported)March 28, 2017
Actual (reported)Kiddie-Sads-Present and Lifetime (KSADS-PL) Scale for PTSD
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
Mood and Feelings Questionnaire (MFQ) for Depressive Symptoms
Up to 39 months
Anxiety Symptoms
Up to 39 months
Global Impairment
Up to 39 months
Incidence of Suicidality
Up to 39 months
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
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 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
Allegheny General Hospital Center for Traumatic Stress in Children and Adolescents
Pittsburgh, Pennsylvania, 15212, United States
Cohen JA, Mannarino AP, Perel JM, Staron V. A pilot randomized controlled trial of combined trauma-focused CBT and sertraline for childhood PTSD symptoms. J Am Acad Child Adolesc Psychiatry. 2007 Jul;46(7):811-9. doi: 10.1097/chi.0b013e3180547105.
Judith A Cohen, M.D.
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
24 participants (actual enrollment reported by the registry).
First Submitted
March 5, 2004
First Posted
March 8, 2004
Study Start
April 2001
Date type not reportedThis date has not been verified as actual or estimated.
12 weeks of Placebo pill, flexible dosage, of 50-150 mg/day, to be administered while receiving TF-CBT
Contact the study team to confirm eligibility.
Primary Completion
March 2006
Actual (reported)Study Completion
March 2006
Actual (reported)Last Updated
April 5, 2017
Results First Posted
March 28, 2017
Record last verified: 2017-04
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Source: ClinicalTrials.gov.
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