Panic Disorder Clinical Trial
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Masking: Double-Blind, Primary Purpose: Treatment
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