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NCT01600456 · ClinicalTrials.gov registry record · Phase 3

Optimizing Posttraumatic Stress Disorder Treatment: Prolonged Exposure (PE) Versus PE Plus Sertraline

A Phase 3 study, sponsored by Case Western Reserve University.

Completed
Registry status
Phase 3
Development phase
150
Enrollment target

NCT01600456: Completed Phase 3 study, sponsored by Case Western Reserve University.

NCT01600456 is a Phase 3 study that has completed, run by Case Western Reserve University. The registered enrollment target is 150 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (81% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01600456, a Phase 3 study, has completed, sponsored by Case Western Reserve University.

COMPLETED
Registry status
Phase 3
Development phase
150 participants
Enrollment target

Study Summary

The specific aims of this study are: 1. To compare the effectiveness of a cognitive behavioral therapy (prolonged exposure, PE) to that of PE and medication (sertraline). 2. To compare the durability of PE gains to that of PE and sertraline at 3, 6, and 9 months post-treatment. 3. To compare those who have chosen their treatment to those who have not in terms of completion of treatment, treatment satisfaction, and short- and long-term effectiveness of the treatment. 4. To examine cost effectiveness of treatment delivery to trauma survivors with PTSD.

Primary Outcome

Interview measure to assess PTSD symptoms.

Interventions

  • BEHAVIORAL Prolonged exposure (PE)
  • OTHER PE plus Sertraline

Trial Details

FieldValue
Enrollment Target 150 participants
Start Date 2011-03
Est. Completion 2017-01
Phase Phase 3
Case Western Reserve University

141 total trials

What the finished NCT01600456 record still lists

NCT01600456 is an interventional study that assigns participants to a tested intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (81% lower).

The record links to 0 conditions, and to 2 interventions - of which Prolonged exposure (PE) is the first listed.

NCT01600456 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01600456 about?

NCT01600456 is a clinical study titled "Optimizing Posttraumatic Stress Disorder Treatment: Prolonged Exposure (PE) Versus PE Plus Sertraline". The specific aims of this study are: 1. To compare the effectiveness of a cognitive behavioral therapy (prolonged exposure, PE) to that of PE and medication (sertraline). 2. To compare the durability of PE gains to that of PE and sertraline at 3, 6, and 9 months post-treatment. 3. To compare those ...

What is the current status of trial NCT01600456?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 150 participants. The study started on 2011-03. Estimated completion is 2017-01.

What interventions are being tested in trial NCT01600456?

The interventions under investigation include: Prolonged exposure (PE) (BEHAVIORAL), PE plus Sertraline (OTHER).

Who is sponsoring clinical trial NCT01600456?

This trial is sponsored by Case Western Reserve University, which has 141 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01600456's enrollment target sits among peer trials

150 1519th of 2000 higher than 455 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 NCT01600456, the US trial registry maintained by the National Library of Medicine. NCT01600456 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.