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Treatment of Panic Disorder: Long Term Strategies

This study has been completed.
Study NCT00000368.   Last updated on October 20, 2006.   Information provided by National Institute of Mental Health (NIMH)

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Descriptive Information Fields
Brief Title  Treatment of Panic Disorder: Long Term Strategies
Official Title 
Brief 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.

Detailed Description

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.

Study Phase Phase III
Study Type  Interventional
Study Design  Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  Panic Disorder
Agoraphobia
Intervention  Behavioral: Cognitive behavior therapy
Drug: Paroxetine or other medication - algorithm used
MEDLINE PMIDs 10815116,   9356566,   11466124,   9829138,   11680551,   9433337
Links Center for Anxiety and Related Disorders [Boston Study Site] This link exits the ClinicalTrials.gov site
Yale Anxiety Disorders Research Clinic [New Haven Study site] This link exits the ClinicalTrials.gov site
Recruitment Information Fields
Recruitment Status  Completed
Enrollment  366
Start Date  February 1999
Completion Date January 2004
Eligibility Criteria 

Inclusion Criteria:

Patients must have:

Panic disorder with or without Agoraphobia. All levels of agoraphobia are included.

Gender Both
Ages 18 Years and older
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00000368
Organization ID R01 MH45964
Secondary IDs †† R01 MH45965, R01 MH45966, R01 MH45963, DSIR AT-CT
Study Sponsor  National Institute of Mental Health (NIMH)
Collaborators ††
Investigators 
Study Chair:     Katherine H. Shear, MD     University of Pittsburgh    
Principal Investigator:     David H Barlow, PhD     Boston University Department of Psychology    
Principal Investigator:     Jack Gorman, MD     Columbia University School of Medicine    
Principal Investigator:     Scott Woods, MD     Yale University    
Information Provided By National Institute of Mental Health (NIMH)
Verification Date November 2005
First Received Date  November 2, 1999
Last Updated Date October 20, 2006

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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