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NCT00025740 · ClinicalTrials.gov registry record · Phase 4
Clonazepam and Paroxetine for Rapid Treatment of Post-Traumatic Stress Disorder
A Phase 4 study, sponsored by National Institute of Mental Health (NIMH).
- Completed
- Registry status
- Phase 4
- Development phase
- 78
- Enrollment target
NCT00025740 is a Phase 4 study that has completed, run by National Institute of Mental Health (NIMH). The registered enrollment target is 78 participants.
The verdict
NCT00025740, a Phase 4 study, has completed, sponsored by National Institute of Mental Health (NIMH).
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 78 participants
- Enrollment target
Study Summary
Post-Traumatic Stress Disorder (PTSD) is an anxiety disorder that follows exposure to an extremely traumatic stressors. PTSD is associated with serious symptoms. While numerous approaches have been used to treat PTSD, these treatments have several limiting factors. This study will evaluate a combination of the drugs clonazepam and paroxetine for the treatment of PTSD symptoms. The main goal of treatment in patients with PTSD is to significantly reduce symptom severity and improve functioning. While numerous approaches have been used to treat PTSD, these treatments are limited by variable response rates, up to a 6-week lag period before clinical response, and sub-optimal side effect profile, including possible worsening of anxiety and insomnia prior to clinical response. The proposed study will examine whether combined treatment with a benzodiazepine (clonazepam) and a selective serotonin reuptake inhibitor (paroxetine) in patients with PTSD will accelerate the onset of clinical response. A second goal is to evaluate whether the rapid and clinically meaningful benefits are sustained until the end of the study, despite tapering off the benzodiazepine at the midpoint of the study. The safety and tolerability of a combination of paroxetine and clonazepam will be compared to paroxetine and placebo (an inactive pill) in the treatment of PTSD. Participants in this study will be randomly assigned to receive either paroxetine plus clonazepam or paroxetine plus a placebo for 12 weeks. Participants will have weekly clinic visits for the first 4 weeks of the study and every other week for the last 8 weeks. Symptoms of PTSD, anxiety, and depression will be evaluated and drug side effects will be noted during the follow-up visits.
Interventions
- DRUG clonazepam and paroxetine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 78 participants |
| Start Date | 2001-10 |
| Est. Completion | 2004-08 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00025740
The ClinicalTrials.gov registry entry for NCT00025740 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 78 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Mental Health (NIMH), which has 343 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which clonazepam and paroxetine is the first listed.
NCT00025740 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00025740 about?
NCT00025740 is a clinical study titled "Clonazepam and Paroxetine for Rapid Treatment of Post-Traumatic Stress Disorder". Post-Traumatic Stress Disorder (PTSD) is an anxiety disorder that follows exposure to an extremely traumatic stressors. PTSD is associated with serious symptoms. While numerous approaches have been used to treat PTSD, these treatments have several limiting factors. This study will evaluate a combina...
What is the current status of trial NCT00025740?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 78 participants. The study started on 2001-10. Estimated completion is 2004-08.
What interventions are being tested in trial NCT00025740?
The interventions under investigation include: clonazepam and paroxetine (DRUG).
Who is sponsoring clinical trial NCT00025740?
This trial is sponsored by National Institute of Mental Health (NIMH), which has 343 total clinical trials registered on ClinicalTrials.gov.
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