Treatment of Panic Disorder: Long Term Strategies

March 17, 2014 updated by: Natalia A. Skritskaya, PhD, New York State Psychiatric Institute

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

379

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

- primary diagnosis of Panic disorder with or without Agoraphobia (all levels of agoraphobia are included).

Exclusion Criteria:

  • current substance abuse or dependence,
  • current active suicidal potential;
  • any history of psychosis, bipolar disorder (I or II) or cyclothymia;
  • pending application or existing medical disability claim;
  • significant cognitive impairment,
  • current uncontrolled general medical illness requiring intervention,
  • psychotherapy directed at anxiety or panic which will not be discontinued by the first treatment visit, and daily use of 2mg of Xanax or equivalent.

Exclusion criteria for paroxetine study:

  • hypersensitivity to Selective Serotonin Reuptake Inhibitors (SSRI),
  • pregnancy, lactation, or planned pregnancy during the course of the study,
  • contemporaneous medication that may interfere or interact with paroxetine,
  • prior treatment with therapeutic doses of paroxetine (40mg/d for 1 mo),
  • concurrent treatment with antidepressants.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Panic Disorder Severity Scale
Time Frame: At baseline and major assessment points plus monthly.
This is a 7-item scale providing ratings of core features of panic disorder and the degree of work and social impairment/interference due to the disorder.
At baseline and major assessment points plus monthly.
Clinical Global Impressions
Time Frame: Monthly, including all nonpretreatment major assessments.
Commonly used global rating of improvement.
Monthly, including all nonpretreatment major assessments.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Albany Panic and Phobia Questionnaire
Time Frame: All major assessment points.
This is a 27-item scale consisting of three subscales that assess fear of agoraphobic situations, social situations, and situations and activities that produce bodily sensations commonly feared by individuals with panic disorder.
All major assessment points.
Anxiety Sensitivity Index
Time Frame: All major assessments and treatment visits.
This is a 16-item scale that assesses person's tendency to regard physiologic arousal as harmful.
All major assessments and treatment visits.
Subjective Symptoms Scale
Time Frame: All major assessment points
This is an individual's rating of the extent to which anxiety symptoms interfere with five areas of daily functioning: work, home management, private leisure, social leisure, and family relationships.
All major assessment points

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

New York State Psychiatric Institute

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Scott Woods, MD, Yale University
  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 1999

Primary Completion (Actual)

July 1, 2004

Study Completion (Actual)

July 1, 2004

Study Registration Dates

First Submitted

November 2, 1999

First Submitted That Met QC Criteria

November 2, 1999

First Posted (Estimate)

November 3, 1999

Study Record Updates

Last Update Posted (Estimate)

March 18, 2014

Last Update Submitted That Met QC Criteria

March 17, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01MH045964 (U.S. NIH Grant/Contract)
  • DSIR AT-CT
  • R01MH045965 (U.S. NIH Grant/Contract)
  • R01MH045966 (U.S. NIH Grant/Contract)
  • R01MH045963 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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