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Pharmacologic Treatment of PTSD in Sexually Abused Children

NCT00078767 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2017-04-05

Study results available
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Summary

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).

Conditions

  • Stress Disorders, Post-Traumatic

Interventions

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

DRUG

Placebo Oral Tablet

12 weeks of Placebo pill, flexible dosage, of 50-150 mg/day, to be administered while receiving TF-CBT

Sponsors & Collaborators

  • National Institute of Mental Health (NIMH)

    collaborator NIH

  • Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

    lead OTHER

Principal Investigators

  • Judith A Cohen, M.D. · Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-04-30
Primary Completion
2006-03-31
Completion
2006-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00078767 on ClinicalTrials.gov