A randomized, controlled trial of aerobic exercise in combination with paroxetine in the treatment of panic disorder

Abstract

Objectives. Regular aerobic exercise (running) has been shown to be superior to a pill placebo in the treatment of panic disorder. Combined drug and exercise treatment has not been investigated in randomized controlled studies to date. Methods. This is a randomized, 10-week, controlled, parallel group, pilot study. A total of 75 outpatients with panic disorder with or without agoraphobia (DSM-IV and ICD-10) received either (1) exercise plus paroxetine 40 mg/day (n=21), (2) relaxation plus paroxetine (n=17), (3) exercise plus pill placebo (n=20), or (4) relaxation plus pill placebo (n=17). Changes in the Panic and Agoraphobia Scale (P&A), and the Clinical Global Impression Scale (CGI) underwent repeated measure analysis. Results. Effects sizes were large for all groups (d=1.53–3.87), however not significantly different. Paroxetine-treated patients were significantly more improved than placebo-treated patients. On the CGI, patients in the exercise groups (plus paroxetine or placebo) had a trend toward better improvement compared to relaxation (P=0.06). Response and remission rates were higher in the paroxetine compared to pill placebo groups. Conclusions. While paroxetine was superior to placebo, aerobic exercise did not differ from relaxation training in most efficacy measures.

Key words::

• Panic disorder
• aerobic exercise
• pharmacotherapy
• double-blind
• clinical trial

Acknowledgements

This study was partially supported by GlaxoSmithKline. The sponsor only covered some of the expenses of the study and had no role in the design and conduct, analysis and interpretation of the data, or preparation, review, and approval of the manuscript.

Statement of Interest

In the last 3 years and in the near future, Dr Wedekind has been/will be on the speakers board for: AstraZeneca, Pfizer, Essex-Pharma, Lundbeck, Novartis, Servier, and Wyeth. In the last 3 years and in the near future, Dr Engel has been/will be on the speakers board for: AstraZeneca. In the last 3 years and in the near future, Dr Bandelow has been/will be on the speakers/advisory board for: AstraZeneca, Cephalon, Bristol-Myers-Squibb, Dainippon Sumitomo, Glaxo, Janssen-Cilag, Jazz, Lilly, Lundbeck, Pfizer, Roche, Servier, Wyeth, and Xian-Janssen. Mrs Neubert was statistician at the Department of Medical Statistics, University of Göttingen and is now an employee at Novartis.