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.

In continuation of prior work from our group (Broocks A, Bandelow B, Pekrun G, et al. Comparison of aerobic exercise, clomipramine, and placebo in the treatment of panic disorder. Am J Psychiatry 1998; 155(5):603-9.) it is the purpose of this trial to test the assumed superiority of a combined therapy of paroxetine and aerobic exercise compared to placebo or unspecific relaxation training in panic disorder. Participants were randomized to a 10 week treatment protocol of paroxetine 40 mg daily or placebo in combination with regular exercise or regular relaxation after having given informed consent and screening of in- and exclusion 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