Treatment of Panic Disorder: Long Term Strategies

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Natalia A. Skritskaya, PhD, New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT00000368
First received: November 2, 1999
Last updated: March 17, 2014
Last verified: March 2014
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment of Panic Disorder: Long Term Strategies

Resource links provided by NLM:


Further study details as provided by New York State Psychiatric Institute:

Primary Outcome Measures:
  • Panic Disorder Severity Scale [ Time Frame: At baseline and major assessment points plus monthly. ] [ Designated as safety issue: No ]
    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.

  • Clinical Global Impressions [ Time Frame: Monthly, including all nonpretreatment major assessments. ] [ Designated as safety issue: No ]
    Commonly used global rating of improvement.


Secondary Outcome Measures:
  • Albany Panic and Phobia Questionnaire [ Time Frame: All major assessment points. ] [ Designated as safety issue: No ]
    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.

  • Anxiety Sensitivity Index [ Time Frame: All major assessments and treatment visits. ] [ Designated as safety issue: No ]
    This is a 16-item scale that assesses person's tendency to regard physiologic arousal as harmful.

  • Subjective Symptoms Scale [ Time Frame: All major assessment points ] [ Designated as safety issue: No ]
    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.


Enrollment: 379
Study Start Date: February 1999
Study Completion Date: July 2004
Primary Completion Date: July 2004 (Final data collection date for primary outcome measure)
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:

- 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
New York State Psychiatric Institute
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

Additional Information:
Publications:
Responsible Party: Natalia A. Skritskaya, PhD, Co-investigator, New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT00000368     History of Changes
Other Study ID Numbers: R01 MH45964, R01MH045964, R01MH045965, R01MH045966, R01MH045963, DSIR AT-CT
Study First Received: November 2, 1999
Last Updated: March 17, 2014
Health Authority: United States: Federal Government

Keywords provided by New York State Psychiatric Institute:
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

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

ClinicalTrials.gov processed this record on July 01, 2015