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

October 4, 2007 updated by: University of Göttingen

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

75

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Göttingen, Germany, 37075
        • University of Göttingen, Dept of Psychiatry and Psychotherapy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Severity of Panic disorder due to Scores on the Panic and Agoraphobia Scale (P&A)
Time Frame: Baseline to endpoint (10 weeks)
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)
Baseline to endpoint (10 weeks)

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Göttingen

Collaborators

GlaxoSmithKline

Investigators

  • Principal Investigator: Borwin Bandelow, Prof, MD, University of Göttingen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2001

Study Completion (Actual)

June 1, 2005

Study Registration Dates

First Submitted

October 3, 2007

First Submitted That Met QC Criteria

October 4, 2007

First Posted (Estimate)

October 5, 2007

Study Record Updates

Last Update Posted (Estimate)

October 5, 2007

Last Update Submitted That Met QC Criteria

October 4, 2007

Last Verified

October 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 290060/552

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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