Randomized Study of Cognitive-Behavioral Therapy Vs Imipramine and Their Combination for Panic Disorder - Full Text View

Sponsor:	National Institute of Mental Health (NIMH)
Collaborator:	Long Island Jewish Medical Center
Information provided by:	National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:	NCT00004834

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:	Treatment, Randomized, Double-Blind, Placebo Control, Efficacy Study

Resource links provided by NLM:

MedlinePlus related topics: Anxiety Mental Health Panic Disorder

Drug Information available for: Imipramine Imipramine hydrochloride

U.S. FDA Resources

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

Estimated Enrollment:	326
Study Start Date:	May 1998

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

Ages Eligible for Study:	18 Years to 64 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004834

Sponsors and Collaborators

National Institute of Mental Health (NIMH)

Long Island Jewish Medical Center

Investigators

Study Chair:

Jack M. Gorman

Long Island Jewish Medical Center

More Information

No publications provided

Study ID Numbers:	199/13462, R10 MH45963, R10 MH45965, R10 MH45964, R10 MH45966
Study First Received:	February 24, 2000
Last Updated:	November 29, 2005
ClinicalTrials.gov Identifier:	NCT00004834 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):

anxiety disorder
disease-related problem/condition
neurologic and psychiatric disorders
panic disorder
rare disease

Additional relevant MeSH terms:

Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Disease
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Physiological Effects of Drugs
Psychotropic Drugs
Pharmacologic Actions

Antidepressive Agents, Tricyclic
Panic Disorder
Imipramine
Pathologic Processes
Anxiety Disorders
Mental Disorders
Therapeutic Uses
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on November 27, 2009