NCT00540098

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

A Randomized, Controlled Trial on the Effects of Paroxetine Versus Placebo in Combination With Aerobic Exercise or Relaxation Training in the Treatment of Panic Disorder

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: University of Göttingen · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Panic Disorder

Interventions

Type	Name	Description
DRUG	paroxetine + aerobic exercise	paroxetine, 40 mg once daily + regular aerobic exercise
DRUG	Paroxetine + relaxation	paroxetine, 40 mg once daily + regular relaxation training
DRUG	Placebo + aerobic exercise	placebo pill once daily + regular aerobic exercise
DRUG	Placebo + relaxation	placebo pill once daily + regular relaxation training

Timeline

• Start date: 2001-09-01
• Completion: 2005-06-01
• First posted: 2007-10-05
• Last updated: 2007-10-05

Locations

1 site across 1 country: Germany