CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 379 enrolled
Drug / intervention
Paroxetine or other medication - algorithm used +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00000368
NCT00000368Phase 3Completed

Treatment of Panic Disorder: Long Term Strategies

New York State Psychiatric Institute·interventional·Posted Nov 3, 1999·Updated Mar 18, 2014

In Brief

A Phase 3 clinical trial evaluating Cognitive behavior therapy and Paroxetine or other medication - algorithm used for Panic Disorder and Agoraphobia. Completed, enrolled 379 participants across 4 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 3CompletedFinished
19992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 3, 1999
Enrollment StartFeb 1, 1999
Primary CompletionJul 1, 2004
TodayJul 2, 2026
Enrollment to primary: 5.4 yearsPosted 26.7 years ago

Interventions

Cognitive behavior therapybehavioral

Paroxetine or other medication - algorithm useddrug