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.

Condition	Treatment or Intervention	Phase
Panic Disorder Agoraphobia	Behavior: Cognitive behavior therapy  Drug: Paroxetine or other medication - algorithm used	Phase III

Further Study Details: 

Expected Total Enrollment:  366

To determine if maintenance CBT produces a more sustained improvement among patients with panic disorder (PD) who respond to an initial course of cognitive behavior therapy (CBT) alone. For those who do not respond sufficiently to CBT alone, to determine if the addition of pharmacotherapy is acceptable and if this improves response among those inadequate responders to CBT alone.

This multicenter study builds upon the findings of a prior study comparing imipramine, placebo, CBT, and their combination in the treatment of PD patients with no more than mild agoraphobia. That study found response rates were as high with CBT or imipramine alone as with their combination. Given the added cost of combined treatments, it therefore seems reasonable to begin with monotherapy. Further, following general principles of medical practice, it would be reasonable to initiate treatment with the less invasive cognitive behavioral intervention. It is then important to learn what should be done following initial treatment.

All patients initially receive CBT alone. Patients are then randomized into 1 of 2 post-acute studies, depending on response status. Responders are randomized to a maintenance study comparing no maintenance with 9 months of continued CBT. Nonresponders are randomized to a study comparing paroxetine with continued CBT. The following outcomes will be examined: the necessity of maintenance therapy in maintaining response; the ability of adjunct pharmacotherapy to improve the response of patients who did not respond to CBT alone; possible predictors of response and relapse; and possible mediators of response.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria: Patients must have: Panic disorder with or without Agoraphobia. All levels of agoraphobia are included.

Connecticut
      Yale University, Department of Psychiatry, Anxiety Disorders Research Clinic, New Haven,  Connecticut,  United States
Massachusetts
      Boston University, Department of Psychology, Center for Anxiety and Related Disorders, Boston,  Massachusetts,  United States
New York
      Hillside Hospital Phobia Clinic, New York,  New York,  United States
Pennsylvania
      University of Pittsburgh, Department of Psychiatry, Panic, Anxiety and Traumatic Grief Program, Pittsburgh,  Pennsylvania,  15213,  United States

Study chairs or principal investigators

Katherine H. Shear, MD,  Study Chair,  University of Pittsburgh   
David H Barlow, PhD,  Principal Investigator,  Boston University Department of Psychology   
Jack Gorman, MD,  Principal Investigator,  Columbia University School of Medicine   
Scott Woods, MD,  Principal Investigator,  Yale University   

Study ID Numbers:  MH045964-11; MH45965 -11; MH045966-10; MH045963-10
Record last reviewed:  November 2004
Last Updated:  November 8, 2004
Record first received:  November 2, 1999
ClinicalTrials.gov Identifier:  NCT00000368
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08