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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.
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
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2011-03 |
| Est. Completion | 2017-01 |
| Phase | Phase 3 |
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.
Learn More About Clinical Trials
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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