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Completed

NCT Number: NCT00540098

Paroxetine vs Placebo Combined With Aerobic Exercise or Relaxation in 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.

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Key information

Conditions

Panic Disorder Anxiety Disorders Behavior Mental Disorders Motor Activity

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Göttingen, Dept of Psychiatry and Psychotherapy

Göttingen, 37075, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

paroxetine + aerobic exercise

Drug

paroxetine, 40 mg once daily + regular aerobic exercise

Paroxetine + relaxation

Drug

paroxetine, 40 mg once daily + regular relaxation training

Placebo + aerobic exercise

Drug

placebo pill once daily + regular aerobic exercise

Placebo + relaxation

Drug

placebo pill once daily + regular relaxation training

Primary outcomes

  1. Severity of Panic disorder due to Scores on the Panic and Agoraphobia Scale (P&A)

    Time frame: Baseline to endpoint (10 weeks)

  2. Severity of panic disorder due to scores on the Clinical Global Impression scale (CGI)

    Time frame: Baseline to endpoint (10 weeks)

Secondary outcomes

  1. Symptom severity due to Hamilton Anxiety Scale (HAMA)

    Time frame: Baseline to endpoint (10 weeks)

  2. Symptom severity due to the Montgomery and Asberg depression rating scale (MADRS)

    Time frame: Baseline to endpoint (10 weeks)

  3. Response and remission analysis between groups

    Time frame: LOCF-analysis

Sponsors and collaborators

Lead sponsor

University of Göttingen

Other

Collaborators

  • GlaxoSmithKline

Registry information

Official study 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

Acronym: Exparox

Important dates

Study start
2001
Study completion
2005
First posted
Oct 5, 2007
Registry last updated
Oct 5, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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