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Pharmacologic Treatment of PTSD in Sexually Abused Children

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00078767
First Posted: March 8, 2004
Last Update Posted: April 5, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Judith Cohen, Allegheny Singer Research Institute
  Purpose
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).

Condition Intervention Phase
Stress Disorders, Post-Traumatic Behavioral: Trauma-Focused Cognitive Behavioral Therapy Drug: Sertraline Pill Drug: Placebo Oral Tablet Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pharmacologic Treatment of PTSD in Sexually Abused Children

Resource links provided by NLM:


Further study details as provided by Judith Cohen, Allegheny Singer Research Institute:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • Mood and Feelings Questionnaire (MFQ) for Depressive Symptoms [ Time Frame: Up to 39 months ]
    Change in depressive symptoms as determined by change in score

  • 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.

  • Global Impairment [ Time Frame: Up to 39 months ]
    Change in Children's Global Assessment Scale (CGAS) between the two groups

  • Incidence of Suicidality [ Time Frame: Up to 39 months ]
    Change in degree of suicidal ideation during study


Enrollment: 24
Study Start Date: April 2001
Study Completion Date: March 2006
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Behavioral: Trauma-Focused Cognitive Behavioral Therapy
12 weeks of Trauma-Focused CBT (TF-CBT)for youth and parent
Drug: Sertraline Pill
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)
Drug: Sertraline Pill
12 weeks of Sertraline pill, flexible dosage of 50-150 mg/day, to be administered while receiving TF-CBT
Drug: Placebo Oral Tablet
12 weeks of Placebo pill, flexible dosage, of 50-150 mg/day, to be administered while receiving TF-CBT

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion:

  1. Ages 10-17 years, inclusive
  2. Confirmed sexual abuse
  3. At least 5 PTSD symptoms on KSADS-PL, with at least one symptom in each of 3 symptom clusters (reexperiencing, avoidance, arousal)
  4. Parent/primary caregiver available to participate in treatment
  5. Assent with parental consent to participate

Exclusion:

  1. Non-English speaking
  2. schizophrenia or other severe psychotic disorder
  3. MR (IQ<60) or PDD preventing CBT treatment
  4. taking current psychotropic medication
  5. documented substance dependence (substance abuse allowed)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00078767


Locations
United States, Pennsylvania
Allegheny General Hospital Center for Traumatic Stress in Children and Adolescents
Pittsburgh, Pennsylvania, United States, 15212
Sponsors and Collaborators
Allegheny Singer Research Institute
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Judith A Cohen, M.D. Allegheny Singer Research Institute
  More Information

Additional Information:
Publications:
Responsible Party: Judith Cohen, Principle Investigator, Allegheny Singer Research Institute
ClinicalTrials.gov Identifier: NCT00078767     History of Changes
Other Study ID Numbers: K02MH001938 ( U.S. NIH Grant/Contract )
First Submitted: March 5, 2004
First Posted: March 8, 2004
Results First Submitted: February 8, 2017
Results First Posted: March 28, 2017
Last Update Posted: April 5, 2017
Last Verified: April 2017

Keywords provided by Judith Cohen, Allegheny Singer Research Institute:
PTSD
Depression
Anxiety

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders
Mental Disorders
Sertraline
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs