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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Panic Disorder

Intervention / Treatment
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* Drug: paroxetine + aerobic exercise
* Drug: Paroxetine + relaxation
* Drug: Placebo + aerobic exercise
* Drug: Placebo + relaxation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Paroxetine + aerobic exercise | Drug: paroxetine + aerobic exercise<br>* paroxetine, 40 mg once daily + regular aerobic exercise<br>|
| Active Comparator: 2<br>Paroxetine + relaxation | Drug: Paroxetine + relaxation<br>* paroxetine, 40 mg once daily + regular relaxation training<br>|
| Active Comparator: 3<br>Placebo + aerobic exercise | Drug: Placebo + aerobic exercise<br>* placebo pill once daily + regular aerobic exercise<br>|
| Placebo Comparator: 4<br>Placebo + relaxation | Drug: Placebo + relaxation<br>* placebo pill once daily + regular relaxation training<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity of Panic disorder due to Scores on the Panic and Agoraphobia Scale (P&A) |  | Baseline to endpoint (10 weeks) | 
| Severity of panic disorder due to scores on the Clinical Global Impression scale (CGI) |  | Baseline to endpoint (10 weeks) | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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panic disorder, pharmacotherapy, non-pharmacological treatment, SSRI, paroxetine, exercise