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NCT01130103 · ClinicalTrials.gov registry record · Phase 4
Combination Treatment for Posttraumatic Stress Disorder (PTSD) After the World Trade Center (WTC) Attack
A Phase 4 study, sponsored by Research Foundation for Mental Hygiene.
- Completed
- Registry status
- Phase 4
- Development phase
- 37
- Enrollment target
NCT01130103: Completed Phase 4 study, sponsored by Research Foundation for Mental Hygiene.
NCT01130103 is a Phase 4 study that has completed, run by Research Foundation for Mental Hygiene. The registered enrollment target is 37 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01130103, a Phase 4 study, has completed, sponsored by Research Foundation for Mental Hygiene.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 37 participants
- Enrollment target
Study Summary
This randomized controlled trial evaluates efficacy of combined prolonged exposure (PE) and the selective serotonin reuptake inhibitor (SSRI) paroxetine in the treatment of survivors of the World Trade Center (WTC) attacks.
Primary Outcome
PTSD severity, minimum = 0 = no symptoms of PTSD maximum = 136 = extremely severe symptoms of PTSD
Interventions
- BEHAVIORAL Prolonged Exposure Therapy
- DRUG Paroxetine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 37 participants |
| Start Date | 2004-03 |
| Est. Completion | 2010-02 |
| Phase | Phase 4 |
What the finished NCT01130103 record still lists
NCT01130103 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 37 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 2 interventions - of which Prolonged Exposure Therapy is the first listed.
NCT01130103 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01130103 about?
NCT01130103 is a clinical study titled "Combination Treatment for Posttraumatic Stress Disorder (PTSD) After the World Trade Center (WTC) Attack". This randomized controlled trial evaluates efficacy of combined prolonged exposure (PE) and the selective serotonin reuptake inhibitor (SSRI) paroxetine in the treatment of survivors of the World Trade Center (WTC) attacks.
What is the current status of trial NCT01130103?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 37 participants. The study started on 2004-03. Estimated completion is 2010-02.
What interventions are being tested in trial NCT01130103?
The interventions under investigation include: Prolonged Exposure Therapy (BEHAVIORAL), Paroxetine (DRUG).
Who is sponsoring clinical trial NCT01130103?
This trial is sponsored by Research Foundation for Mental Hygiene, which has 27 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01130103's enrollment target sits among peer trials
37 1482nd of 2000 higher than 511 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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