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

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
University of Göttingen
ClinicalTrials.gov Identifier:
NCT00540098
First received: October 3, 2007
Last updated: October 4, 2007
Last verified: October 2007
History of Changes
  Purpose

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:

U.S. FDA Resources

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00540098

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

Publications:

ClinicalTrials.gov 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
pharmacotherapy
non-pharmacological treatment
 SSRI
paroxetine
exercise

Additional relevant MeSH terms:
Panic Disorder
Anxiety Disorders
Mental Disorders
Paroxetine
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

ClinicalTrials.gov processed this record on May 22, 2013