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

This study has been completed.
Information provided by:
University of Göttingen Identifier:
First received: October 3, 2007
Last updated: October 4, 2007
Last verified: October 2007

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.

Condition Intervention Phase
Panic Disorder
Drug: paroxetine + aerobic exercise
Drug: Paroxetine + relaxation
Drug: Placebo + aerobic exercise
Drug: Placebo + relaxation
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by University of Göttingen:

Primary Outcome 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 Outcome 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 ]

Enrollment: 75
Study Start Date: September 2001
Study Completion Date: June 2005
Arms Assigned Interventions
Experimental: 1
Paroxetine + aerobic exercise
Drug: paroxetine + aerobic exercise
paroxetine, 40 mg once daily + regular aerobic exercise
Active Comparator: 2
Paroxetine + relaxation
Drug: Paroxetine + relaxation
paroxetine, 40 mg once daily + regular relaxation training
Active Comparator: 3
Placebo + aerobic exercise
Drug: Placebo + aerobic exercise
placebo pill once daily + regular aerobic exercise
Placebo Comparator: 4
Placebo + relaxation
Drug: Placebo + relaxation
placebo pill once daily + regular relaxation training

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.


Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Please refer to this study by its identifier: NCT00540098

University of Göttingen, Dept of Psychiatry and Psychotherapy
Göttingen, Germany, 37075
Sponsors and Collaborators
University of Göttingen
Principal Investigator: Borwin Bandelow, Prof, MD University of Göttingen
  More Information

Publications: Identifier: NCT00540098     History of Changes
Other Study ID Numbers: 290060/552
Study First Received: October 3, 2007
Last Updated: October 4, 2007
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Göttingen:
panic disorder
non-pharmacological treatment

Additional relevant MeSH terms:
Panic Disorder
Anxiety Disorders
Mental Disorders
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses processed this record on April 17, 2014