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

Official Title: “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”

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.

Intervention(s) in this Clinical Trial

• 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

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Paroxetine + aerobic exercise
• Active Comparator: 2
  • Paroxetine + relaxation
• Active Comparator: 3
  • Placebo + aerobic exercise
• Placebo Comparator: 4
  • Placebo + relaxation

Primary Measures

• Severity of Panic disorder due to Scores on the Panic and Agoraphobia Scale (P&A)
  • Time Frame: Baseline to endpoint (10 weeks)
    
• Severity of panic disorder due to scores on the Clinical Global Impression scale (CGI)
  • Time Frame: Baseline to endpoint (10 weeks)
    

Secondary Measures

• Symptom severity due to Hamilton Anxiety Scale (HAMA)
  • Time Frame: Baseline to endpoint (10 weeks)
    
• Symptom severity due to the Montgomery and Asberg depression rating scale (MADRS)
  • Time Frame: Baseline to endpoint (10 weeks)
    
• Response and remission analysis between groups
  • Time Frame: LOCF-analysis
    

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 60 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: University of Göttingen Other

Overall Clinical Trial Officials and Contacts

Borwin Bandelow, Prof, MD Principal Investigator University of Göttingen  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00540098

Study ID Number: 290060/552

ClinicalTrials.gov Identifier: NCT00540098

Health Authority: Germany: Federal Institute for Drugs and Medical Devices