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NCT01681849 · ClinicalTrials.gov registry record · Phase 4
Neural Circuits in Women With Abuse and Posttraumatic Stress Disorder
A Phase 4 study, sponsored by Emory University.
- Completed
- Registry status
- Phase 4
- Development phase
- 91
- Enrollment target
NCT01681849: Completed Phase 4 study, sponsored by Emory University.
NCT01681849 is a Phase 4 study that has completed, run by Emory University. The registered enrollment target is 91 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01681849, a Phase 4 study, has completed, sponsored by Emory University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 91 participants
- Enrollment target
Study Summary
The purpose of this study was to assess the effects of the medication paroxetine on symptoms of posttraumatic stress disorder (PTSD) and the brain in women with a history of PTSD related to childhood abuse. The hypothesis is that paroxetine will result in an improvement in PTSD symptoms accompanied by changes in brain functional response to reminders of childhood trauma.
Primary Outcome
The CAPS is a 30-item questionnaire of PTSD symptomatology that provides continuous measures of symptom severity and frequency. CAPS-IV total symptom severity score is calculated by summing severity scores for the 17 DSM-IV PTSD symptoms. Each symptom is rated for severity based on frequency and intensity on a scale of 0-4 for a total possible severity score per symptom of 8. Criterion E (items 18-19) is duration of symptoms (minimum of one month to make the diagnosis). Items 20-30 are optional.
Interventions
- DRUG Placebo
- DRUG Paroxetine
- OTHER Positron Emission Tomography (PET) Imaging
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 91 participants |
| Start Date | 2009-07 |
| Est. Completion | 2015-07 |
| Phase | Phase 4 |
What the finished NCT01681849 record still lists
NCT01681849 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 91 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (82% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01681849 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01681849 about?
NCT01681849 is a clinical study titled "Neural Circuits in Women With Abuse and Posttraumatic Stress Disorder". The purpose of this study was to assess the effects of the medication paroxetine on symptoms of posttraumatic stress disorder (PTSD) and the brain in women with a history of PTSD related to childhood abuse. The hypothesis is that paroxetine will result in an improvement in PTSD symptoms accompanied ...
What is the current status of trial NCT01681849?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 91 participants. The study started on 2009-07. Estimated completion is 2015-07.
What interventions are being tested in trial NCT01681849?
The interventions under investigation include: Placebo (DRUG), Paroxetine (DRUG), Positron Emission Tomography (PET) Imaging (OTHER).
Who is sponsoring clinical trial NCT01681849?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01681849's enrollment target sits among peer trials
91 884th of 2000 higher than 1,115 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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