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NCT00078767 · ClinicalTrials.gov registry record · Phase 3

Pharmacologic Treatment of PTSD in Sexually Abused Children

A Phase 3 study, sponsored by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute).

Completed
Registry status
Phase 3
Development phase
24
Enrollment target

NCT00078767: Completed Phase 3 study, sponsored by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute).

NCT00078767 is a Phase 3 study that has completed, run by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute). The registered enrollment target is 24 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00078767, a Phase 3 study, has completed, sponsored by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute).

COMPLETED
Registry status
Phase 3
Development phase
24 participants
Enrollment target

Study 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).

Primary Outcome

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

Interventions

  • DRUG Placebo Oral Tablet
  • BEHAVIORAL Trauma-Focused Cognitive Behavioral Therapy
  • DRUG Sertraline Pill

Trial Details

FieldValue
Enrollment Target 24 participants
Start Date 2001-04
Est. Completion 2006-03
Phase Phase 3

What the finished NCT00078767 record still lists

NCT00078767 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (97% lower).

The record links to 0 conditions, and to 3 interventions - of which Placebo Oral Tablet is the first listed.

NCT00078767 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00078767 about?

NCT00078767 is a clinical study titled "Pharmacologic Treatment of PTSD in Sexually Abused Children". 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).

What is the current status of trial NCT00078767?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 24 participants. The study started on 2001-04. Estimated completion is 2006-03.

What interventions are being tested in trial NCT00078767?

The interventions under investigation include: Placebo Oral Tablet (DRUG), Trauma-Focused Cognitive Behavioral Therapy (BEHAVIORAL), Sertraline Pill (DRUG).

Who is sponsoring clinical trial NCT00078767?

This trial is sponsored by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute), which has 34 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00078767's enrollment target sits among peer trials

24 1943rd of 2000 higher than 49 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00078767, the US trial registry maintained by the National Library of Medicine. NCT00078767 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.