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

• Status: Completed
• Trial end date: 2005-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Northwell Health
• Collaborators: Long Island Jewish Medical Center; National Institute of Mental Health (NIMH)
• Treatments: Imipramine

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