Randomized Study of Cognitive-Behavioral Therapy vs Imipramine and Their Combination for Panic Disorder
|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.|
|ClinicalTrials.gov Identifier: NCT00004834|
Recruitment Status : Completed
First Posted : February 25, 2000
Last Update Posted : February 21, 2013
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 or disease||Intervention/treatment||Phase|
|Panic Disorder||Drug: imipramine Behavioral: cognitive-behavioral therapy||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||326 participants|
|Study Start Date :||May 1998|
|Actual Primary Completion Date :||June 2005|
|Actual Study Completion Date :||June 2005|
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
|Study Chair:||Jack M. Gorman||Long Island Jewish Medical Center|