Treatment of Panic Disorder: Long Term Strategies
NCT00000368 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 379
Last updated 2014-03-18
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.
Conditions
- Panic Disorder
- Agoraphobia
Interventions
- BEHAVIORAL
-
Cognitive behavior therapy
- DRUG
-
Paroxetine or other medication - algorithm used
Sponsors & Collaborators
-
National Institute of Mental Health (NIMH)
collaborator NIH -
New York State Psychiatric Institute
lead OTHER
Principal Investigators
-
Katherine H. Shear, MD · University of Pittsburgh
-
David H Barlow, PhD · Boston University Department of Psychology
-
Jack Gorman, MD · Columbia University School of Medicine
-
Scott Woods, MD · Yale University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 1999-02-28
- Primary Completion
- 2004-07-31
- Completion
- 2004-07-31
Countries
- United States
Study Locations
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