An interventional study of imipramine and cognitive-behavioral therapy in Panic Disorder, sponsored by Northwell Health. Completed. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2013-02-21.
Sponsored by Northwell Health · Not applicable, Interventional, and Treatment
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.
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.
250 studies on the registry are indexed under Panic Disorder; 35 are open to participants now.
This study's enrollment of 326 is above the median of 80 across 195 interventional studies indexed under Panic Disorder.
Browse Panic Disorder studies →Northwell Health is the lead sponsor of 463 studies on the registry; 109 are open to participants now.
Of its 40 completed or terminated interventional studies of FDA-regulated products, 20 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
--Prior/Concurrent Therapy--
--Patient Characteristics--
No study locations are listed for this record.
This study is completed, as verified in Feb 2013. You cannot join it, but the record below documents what was studied.
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