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NCT00031317 · ClinicalTrials.gov registry record · Phase 4
Evaluation of Clonazepam and Paroxetine for Panic Disorder With Depression
A Phase 4 study, sponsored by National Institute of Mental Health (NIMH).
- Completed
- Registry status
- Phase 4
- Development phase
- 60
- Enrollment target
NCT00031317: Completed Phase 4 study, sponsored by National Institute of Mental Health (NIMH).
NCT00031317 is a Phase 4 study that has completed, run by National Institute of Mental Health (NIMH). The registered enrollment target is 60 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00031317, a Phase 4 study, has completed, sponsored by National Institute of Mental Health (NIMH).
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 60 participants
- Enrollment target
Study Summary
The purpose of this study is to examine the safety and effectiveness of the drug combination paroxetine and clonazepam in treating people with panic disorder (PD) and major depression. The main goal in treating people with PD is to rapidly reduce symptom severity and improve functioning. While numerous drug therapies have been used to treat PD, these treatments are limited by variable response rates and suboptimal side effect profiles. Evidence suggests that clonazepam given with a selective serotonin reuptake inhibitor (SSRI) can facilitate a rapid reduction in PD symptoms. However, it is unclear whether comorbid depression influences treatment response to the clonazepam and SSRI regimen. This study will examine whether combined treatment with clonazepam and the SSRI paroxetine will accelerate clinical response in participants with PD and comorbid depression. This study will also examine whether the benefits of treatment will be sustained until the end of the study despite tapering of clonazepam at the midpoint of the study. Participants in this study will be screened with medical and psychiatric interviews, a physical examination, electrocardiogram (ECG), and blood tests. Participants will then be randomly assigned to receive either paroxetine plus clonazepam or paroxetine plus placebo (an inactive pill) for 12 weeks. Participants will have weekly clinic visits during which symptoms and drug side effects will be checked and an interview to evaluate panic disorder and depression symptoms will be conducted.
Interventions
- DRUG Clozapine
- DRUG Paroxetine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2002-02 |
| Est. Completion | 2005-06 |
| Phase | Phase 4 |
What the finished NCT00031317 record still lists
NCT00031317 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 2 interventions - of which Clozapine is the first listed.
NCT00031317 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00031317 about?
NCT00031317 is a clinical study titled "Evaluation of Clonazepam and Paroxetine for Panic Disorder With Depression". The purpose of this study is to examine the safety and effectiveness of the drug combination paroxetine and clonazepam in treating people with panic disorder (PD) and major depression. The main goal in treating people with PD is to rapidly reduce symptom severity and improve functioning. While nume...
What is the current status of trial NCT00031317?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 60 participants. The study started on 2002-02. Estimated completion is 2005-06.
What interventions are being tested in trial NCT00031317?
The interventions under investigation include: Clozapine (DRUG), Paroxetine (DRUG).
Who is sponsoring clinical trial NCT00031317?
This trial is sponsored by National Institute of Mental Health (NIMH), which has 343 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00031317's enrollment target sits among peer trials
60 1125th of 2000 higher than 799 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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