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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 is a Phase 4 study that has completed, run by National Institute of Mental Health (NIMH). The registered enrollment target is 60 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00031317
The ClinicalTrials.gov registry entry for NCT00031317 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 60 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 2 interventions - of which Clozapine is the first listed.
NCT00031317 reports 0 study locations.
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.
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