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Sponsored by: |
National Institute of Mental Health (NIMH) |
Information provided by: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00000368 |
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 | Intervention | Phase |
Panic Disorder Agoraphobia |
Behavioral: Cognitive behavior therapy Drug: Paroxetine or other medication - algorithm used |
Phase III |
MedlinePlus related topics: | Anxiety Panic Disorder |
Drug Information available for: | Paroxetine Paroxetine hydrochloride Paroxetine Mesylate Serotonin |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Estimated Enrollment: | 366 |
Study Start Date: | February 1999 |
Estimated Study Completion Date: | January 2004 |
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 older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients must have:
Panic disorder with or without Agoraphobia. All levels of agoraphobia are included.
United States, Connecticut | |||||
Yale University, Department of Psychiatry, Anxiety Disorders Research Clinic | |||||
New Haven, Connecticut, United States | |||||
United States, Massachusetts | |||||
Boston University, Department of Psychology, Center for Anxiety and Related Disorders | |||||
Boston, Massachusetts, United States | |||||
United States, New York | |||||
Hillside Hospital Phobia Clinic | |||||
New York, New York, United States | |||||
United States, Pennsylvania | |||||
University of Pittsburgh, Department of Psychiatry, Panic, Anxiety and Traumatic Grief Program | |||||
Pittsburgh, Pennsylvania, United States, 15213 |
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 |
Center for Anxiety and Related Disorders [Boston Study Site] 
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Yale Anxiety Disorders Research Clinic [New Haven Study site] 
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Study ID Numbers: | R01 MH45964, R01 MH45965, R01 MH45966, R01 MH45963, DSIR AT-CT |
First Received: | November 2, 1999 |
Last Updated: | October 20, 2006 |
ClinicalTrials.gov Identifier: | NCT00000368 |
Health Authority: | United States: Federal Government |
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