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NCT00000368 · ClinicalTrials.gov registry record · Phase 3
Treatment of Panic Disorder: Long Term Strategies
A Phase 3 study, sponsored by New York State Psychiatric Institute.
- Completed
- Registry status
- Phase 3
- Development phase
- 379
- Enrollment target
NCT00000368: Completed Phase 3 study, sponsored by New York State Psychiatric Institute.
NCT00000368 is a Phase 3 study that has completed, run by New York State Psychiatric Institute. The registered enrollment target is 379 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (51% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00000368, a Phase 3 study, has completed, sponsored by New York State Psychiatric Institute.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 379 participants
- Enrollment target
Study Summary
Cognitive behavior therapy (CBT) with or without medication has been used in the treatment of panic disorder (PD). The purpose of this study is 1) to determine whether nine months of maintenance cognitive-behavior therapy (CBT) significantly improves the likelihood of sustained improvement; and 2) to determine the acute acceptability and efficacy of medication therapy or continued CBT alone among patients who fail to respond sufficiently to an initial course of CBT alone. It has been found that patients with PD respond as well to CBT or medication alone as they do to a combination of the two. Since the combined treatments are expensive and CBT is associated with less risk of medical toxicity compared to medications, CBT alone will be used first. All patients will first receive CBT alone. If the patient responds to this therapy, the patient will be assigned randomly (like tossing a coin) to 1 of 2 groups. One group will continue to receive CBT (maintenance therapy) for 9 months. The other group of responders will not receive any further therapy. If a patient does not respond to CBT alone, he/she will be assigned randomly to 1 of 2 different groups. One group will receive paroxetine; the other will continue to receive CBT for a longer period. The response to treatment will be evaluated to see which regimen works best to treat PD. The study will last approximately 3 years. An individual may be eligible for this study if he/she has panic disorder with no more than mild agoraphobia (fear of being in public places) and is at least 18 years old.
Primary Outcome
This is a 7-item scale providing ratings of core features of panic disorder and the degree of work and social impairment/interference due to the disorder.
Interventions
- BEHAVIORAL Cognitive behavior therapy
- DRUG Paroxetine or other medication - algorithm used
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 379 participants |
| Start Date | 1999-02 |
| Est. Completion | 2004-07 |
| Phase | Phase 3 |
What the finished NCT00000368 record still lists
NCT00000368 is an interventional study that assigns participants to a tested intervention. The registered 379 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (51% lower).
The record links to 0 conditions, and to 2 interventions - of which Cognitive behavior therapy is the first listed.
NCT00000368 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00000368 about?
NCT00000368 is a clinical study titled "Treatment of Panic Disorder: Long Term Strategies". Cognitive behavior therapy (CBT) with or without medication has been used in the treatment of panic disorder (PD). The purpose of this study is 1) to determine whether nine months of maintenance cognitive-behavior therapy (CBT) significantly improves the likelihood of sustained improvement; and 2) t...
What is the current status of trial NCT00000368?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 379 participants. The study started on 1999-02. Estimated completion is 2004-07.
What interventions are being tested in trial NCT00000368?
The interventions under investigation include: Cognitive behavior therapy (BEHAVIORAL), Paroxetine or other medication - algorithm used (DRUG).
Who is sponsoring clinical trial NCT00000368?
This trial is sponsored by New York State Psychiatric Institute, which has 364 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00000368's enrollment target sits among peer trials
379 987th of 2000 higher than 1,013 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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