Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Treatment of Panic Disorder: Long Term Strategies
This study has been completed.
Sponsored by: National Institute of Mental Health (NIMH)
Information provided by: National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT00000368
  Purpose

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
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Further study details as provided by National Institute of Mental Health (NIMH):

Estimated Enrollment: 366
Study Start Date: February 1999
Estimated Study Completion Date: January 2004
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patients must have:

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00000368

Locations
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
Sponsors and 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
  More Information

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

Publications:
Study ID Numbers: R01 MH45964, R01 MH45965, R01 MH45966, R01 MH45963, DSIR AT-CT
Study First Received: November 2, 1999
Last Updated: October 20, 2006
ClinicalTrials.gov Identifier: NCT00000368  
Health Authority: United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):
Adult
Cognitive Behavioral Therapy
Pharmacotherapy
Long term treatment
Remission and relapse
Male
Panic Disorder
Paroxetine
Serotonin Uptake Inhibitors
Panic Disorder -- *therapy
Panic Disorder -- drug therapy
Paroxetine -- *therapeutic use
Serotonin Uptake Inhibitors -- *therapeutic use

Study placed in the following topic categories:
Panic Disorder
Anxiety Disorders
Mental Disorders
Agoraphobia
Paroxetine
Serotonin

Additional relevant MeSH terms:
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Disease
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Uptake Inhibitors
Pharmacologic Actions
Pathologic Processes
Serotonin Agents
Therapeutic Uses
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on January 15, 2009