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Randomized Study of Cognitive-Behavioral Therapy vs Imipramine and Their Combination for Panic Disorder

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00004834
First Posted: February 25, 2000
Last Update Posted: February 21, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Institute of Mental Health (NIMH)
Long Island Jewish Medical Center
Information provided by (Responsible Party):
Northwell Health
  Purpose

OBJECTIVES:

I. Determine which treatment is most effective for patients with panic disorder: cognitive-behavioral therapy (CBT) plus imipramine (IMI), CBT plus placebo, CBT alone, IMI alone, or placebo alone.


Condition Intervention
Panic Disorder Drug: imipramine Behavioral: cognitive-behavioral therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Northwell Health:

Estimated Enrollment: 326
Study Start Date: May 1998
Study Completion Date: June 2005
Primary Completion Date: June 2005 (Final data collection date for primary outcome measure)
Detailed Description:

PROTOCOL OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are randomized to receive one of five treatments: cognitive-behavioral therapy (CBT) alone, imipramine plus medical management (IMI), CBT plus IMI, pill placebo plus medical management (PLA), or CBT plus PLA.

Patients are seen by therapists for 11 sessions over 12 weeks (3 sessions during days 1-10 followed by 6 weekly sessions and 2 biweekly sessions). Each CBT session lasts approximately 1 hour, each IMI session lasts approximately 30 minutes, and patients in combined treatment see 2 therapists for a total of about 80 minutes. Oral IMI or placebo is taken daily.

Patients not responding to placebo or IMI after the initial 12 weeks are offered alternative treatment for up to 3 months or given a referral; responders continue to be treated monthly for the next 6 months. This is followed by a washout period of 6 months, after which patients receive final assessment. All therapy and assessment sessions are video- or audiotaped.

Patients are interviewed by an independent evaluator at the start of treatment and 3, 9, and 15 months later, and must keep a set of weekly self-monitoring forms. In addition, patients complete rating forms and questionnaires, and undergo carbon dioxide measurement at the start of treatment and 3, 9, and 15 months later.

At study conclusion, patients are told which medication they received and receive treatment recommendations.

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

  • Principal diagnosis of panic disorder with or without mild agoraphobia, confirmed using the Anxiety Disorders Interview Schedule-Revised
  • At least one full or limited panic attack per week within 2 weeks prior to initial assessment and 2 weeks prior to treatment

--Prior/Concurrent Therapy--

  • Drug washout required if on anxiolytic or antidepressant medication No more than 10 benzodiazepine doses (0.5 mg alprazolam equivalent) within 2 weeks prior to treatment No more than 20 doses of benzodiazepine during baseline and acute treatment combined No more than one dose of benzodiazepine per day permitted
  • No concurrent competing treatment

--Patient Characteristics--

  • Not pregnant Negative serum pregnancy test required Effective contraception required of fertile women No psychotic, bipolar, or significant medical illnesses Not suicidal No significant substance abuse No prior nonresponse to either study treatment or related treatments No concurrent disability claims
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004834


Sponsors and Collaborators
Northwell Health
National Institute of Mental Health (NIMH)
Long Island Jewish Medical Center
Investigators
Study Chair: Jack M. Gorman Long Island Jewish Medical Center
  More Information

Responsible Party: Northwell Health
ClinicalTrials.gov Identifier: NCT00004834     History of Changes
Other Study ID Numbers: 199/13462
R10MH045963 ( U.S. NIH Grant/Contract )
R10MH045965 ( U.S. NIH Grant/Contract )
R10MH045964 ( U.S. NIH Grant/Contract )
R10MH045966 ( U.S. NIH Grant/Contract )
First Submitted: February 24, 2000
First Posted: February 25, 2000
Last Update Posted: February 21, 2013
Last Verified: February 2013

Keywords provided by Northwell Health:
anxiety disorder
disease-related problem/condition
neurologic and psychiatric disorders
panic disorder
rare disease

Additional relevant MeSH terms:
Disease
Panic Disorder
Pathologic Processes
Anxiety Disorders
Mental Disorders
Imipramine
Antidepressive Agents, Tricyclic
Antidepressive Agents
Psychotropic Drugs
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs