Treatment of Panic Disorder: Long Term Strategies

NCT00000368 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 379

Last updated 2014-03-18

No results posted yet for this 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.

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00000368 on ClinicalTrials.gov