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

Phase 4

Completed

• Conditions: Panic Disorder
• Interventions: Drug: paroxetine + aerobic exercise; Drug: Placebo + aerobic exercise; Drug: Paroxetine + relaxation; Drug: Placebo + relaxation

• Registration Number: NCT00540098
• Lead Sponsor: University of Göttingen

Brief Summary

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

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 Timeline

• Study Start: 2001-09
• Study Completion: 2005-06
• Status Verified: 2007-10
• Study First Submitted: 2007-10-03
• Study First Submitted QC: 2007-10-04
• Last Update Submitted: 2007-10-04
• Study First Posted: 2007-10-05
• Last Update Posted: 2007-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	paroxetine + aerobic exercise	Paroxetine + aerobic exercise
3	Placebo + aerobic exercise	Placebo + aerobic exercise
2	Paroxetine + relaxation	Paroxetine + relaxation
4	Placebo + relaxation	Placebo + relaxation

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

University of Göttingen, Dept of Psychiatry and Psychotherapy; 🇩🇪 Göttingen, Germany