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NCT01524133 · ClinicalTrials.gov registry record · Phase 4
PROlonGed ExpoSure Sertraline
A Phase 4 study, sponsored by VA Ann Arbor Healthcare System.
- Completed
- Registry status
- Phase 4
- Development phase
- 223
- Enrollment target
NCT01524133: Completed Phase 4 study, sponsored by VA Ann Arbor Healthcare System.
NCT01524133 is a Phase 4 study that has completed, run by VA Ann Arbor Healthcare System. The registered enrollment target is 223 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (57% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01524133, a Phase 4 study, has completed, sponsored by VA Ann Arbor Healthcare System.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 223 participants
- Enrollment target
Study Summary
The current research study aims to compare the effectiveness of two proven treatments for posttraumatic stress disorder (PTSD): Prolonged Exposure (PE), sertraline, and their combination. In addition, the investigators are examining predictors of response to these two treatments and how PTSD symptoms, thoughts, and biological factors may be changed by such treatments. Biological mechanisms of change are also examined including emotion processing and regulation in fMRI, HPA axis function, and genetics and genomics. In addition, the investigators will examine acceptability of each treatment and reasons for ending treatment.
Primary Outcome
Total Score; Range 0-136 with increasing PTSD severity as scores increase
Interventions
- BEHAVIORAL Prolonged Exposure Therapy
- DRUG Sertraline
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 223 participants |
| Start Date | 2011-11 |
| Est. Completion | 2017-05 |
| Phase | Phase 4 |
What the finished NCT01524133 record still lists
NCT01524133 is an interventional study that assigns participants to a tested intervention. The registered 223 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (57% lower).
The record links to 0 conditions, and to 2 interventions - of which Prolonged Exposure Therapy is the first listed.
NCT01524133 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01524133 about?
NCT01524133 is a clinical study titled "PROlonGed ExpoSure Sertraline". The current research study aims to compare the effectiveness of two proven treatments for posttraumatic stress disorder (PTSD): Prolonged Exposure (PE), sertraline, and their combination. In addition, the investigators are examining predictors of response to these two treatments and how PTSD symptom...
What is the current status of trial NCT01524133?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 223 participants. The study started on 2011-11. Estimated completion is 2017-05.
What interventions are being tested in trial NCT01524133?
The interventions under investigation include: Prolonged Exposure Therapy (BEHAVIORAL), Sertraline (DRUG).
Who is sponsoring clinical trial NCT01524133?
This trial is sponsored by VA Ann Arbor Healthcare System, which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01524133's enrollment target sits among peer trials
223 383rd of 2000 higher than 1,618 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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