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NCT00645450 · ClinicalTrials.gov registry record · Phase 4
PTSD Symptom Reduction by Propranolol Given After Trauma Memory Activation
A Phase 4 study, sponsored by VA Office of Research and Development.
- Terminated
- Registry status
- Phase 4
- Development phase
- 9
- Enrollment target
NCT00645450: Clinical Trial Phase 4 study, sponsored by VA Office of Research and Development.
NCT00645450 is a Phase 4 study that was terminated before completion, run by VA Office of Research and Development. The registered enrollment target is 9 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00645450, a Phase 4 study, was terminated before completion, sponsored by VA Office of Research and Development.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 9 participants
- Enrollment target
Study Summary
This study is a randomized, double-blind, placebo-controlled clinical trial of propranolol combined with trauma memory reactivation, to determination if this approach is effective in treating PTSD symptoms. Participants will include male and female combat Veterans of the Afghanistan and Iraqi wars meeting DSM-IV criteria for chronic PTSD, recruited locally from the Manchester VAMC Mental Hygiene Clinic or through advertising. The presence of PTSD will be assessed using the CAPS. Participants will be randomly assigned to the propranolol or placebo drug condition. During each of six memory reactivation sessions, the participant will meet with a psychiatrist, who will ask the participant to spend ten minutes describing the event that caused their PTSD, and their reactions to it. The interviewer will facilitate this process by asking questions, keeping the participant focused on the traumatic event and encouraging him/her to identify aspects of the traumatic event that continue to provoke emotional distress. The traumatic memory reactivation will be immediately followed by administration of propranolol or placebo. Following the six treatment sessions, script-driven imagery will be used to assess HR, SC, and facial EMG responses to recollections of the traumatic event and PTSD symptoms will be assessed using the CAPS. A previously developed discriminant function will be used to classify each person as a physiologic "responder" or "non-responder." There will also be a 6-month follow-up assessment.
Interventions
- DRUG Placebo
- DRUG Propranolol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2008-04 |
| Est. Completion | 2010-12 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00645450
The ClinicalTrials.gov registry entry for NCT00645450 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 9 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is VA Office of Research and Development, which has 1,668 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00645450 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00645450 about?
NCT00645450 is a clinical study titled "PTSD Symptom Reduction by Propranolol Given After Trauma Memory Activation". This study is a randomized, double-blind, placebo-controlled clinical trial of propranolol combined with trauma memory reactivation, to determination if this approach is effective in treating PTSD symptoms. Participants will include male and female combat Veterans of the Afghanistan and Iraqi wars m...
What is the current status of trial NCT00645450?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 9 participants. The study started on 2008-04. Estimated completion is 2010-12.
What interventions are being tested in trial NCT00645450?
The interventions under investigation include: Placebo (DRUG), Propranolol (DRUG).
Who is sponsoring clinical trial NCT00645450?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
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