Paroxetine vs Placebo Combined With Aerobic Exercise or Relaxation in Panic Disorder

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

Summary

Efficacy and safety of a 10-weeks treatment protocol of paroxetine vs. placebo in combination with regular aerobic exercise (running) or regular relaxation training in the treatment of panic disorder.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Göttingen
• Collaborator: GlaxoSmithKline
• Treatments: Paroxetine

Criteria

Inclusion Criteria:

• Panic disorder with or without agoraphobia due to DSM-IV

• Written informed consent

• Score of 17 or more on the P&A scale

• Score on the CGI of 4 or more (markedly ill)

Exclusion Criteria:

• Pregnancy, lactating or insufficient contraception (pearl index >1)

• Other psychiatric disorders such as psychoses, addictive disorders, dementia, etc.

• Clinically relevant abnormalities in physical examination or laboratory results

• Prior major depression or bipolar disorder

• Suicidality

• psychotropic medication other than promethazine

• current psychological treatment

• unable to perform regular aerobic exercise