CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 24 enrolled
Drug / intervention
Sertraline Pill +2 moredrug
Likely dose
Sertraline 50–150 mg orally once daily, flexible dosing over 12 weeksAI-extracted
Key inclusion· 5
  • Age 10–17 years inclusive
  • Confirmed history of sexual abuse
  • At least 5 PTSD symptoms documented on KSADS-PL with symptoms present in each of the three clusters (reexperiencing, avoidance, arousal)
  • Parent or primary caregiver must be available and willing to participate in treatment
Key exclusion· 5
  • Non-English speaking
  • Schizophrenia or other severe psychotic disorder
  • Intellectual disability (IQ <60) or pervasive developmental disorder preventing CBT treatment
  • Currently taking psychotropic medication

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00078767
NCT00078767Phase 3Completed

Pharmacologic Treatment of PTSD in Sexually Abused Children

In Brief

A Phase 3 clinical trial evaluating Trauma-Focused Cognitive Behavioral Therapy, Sertraline Pill, and 1 other intervention for Stress Disorders, Post-Traumatic. Completed, enrolled 24 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 3CompletedFinished
200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 8, 2004
Enrollment StartApr 1, 2001
Primary CompletionMar 1, 2006
TodayJul 2, 2026
Enrollment to primary: 4.9 yearsPosted 22.3 years ago

Interventions

Trauma-Focused Cognitive Behavioral Therapybehavioral

12 weeks of Trauma-Focused CBT (TF-CBT)for youth and parent

Sertraline Pilldrug

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

Placebo Oral Tabletdrug

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