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

Panic Disorder Clinical Trial

— Exparox  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00540098
• Other study ID #: 290060/552
• Status: Completed
• Phase: Phase 4
• First received: October 3, 2007
• Last updated: October 4, 2007
• Start date: September 2001
• Est. completion date: June 2005

Study information

• Verified date: October 2007
• Source: University of Göttingen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: June 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Panic Disorder

Intervention

Drug:
• paroxetine + aerobic exercise
paroxetine, 40 mg once daily + regular aerobic exercise
• Paroxetine + relaxation
paroxetine, 40 mg once daily + regular relaxation training
• Placebo + aerobic exercise
placebo pill once daily + regular aerobic exercise
• Placebo + relaxation
placebo pill once daily + regular relaxation training

Locations

Country	Name	City	State
Germany	University of Göttingen, Dept of Psychiatry and Psychotherapy	Göttingen

Sponsors (2)

Lead Sponsor	Collaborator
University of Göttingen	GlaxoSmithKline

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Broocks A, Bandelow B, Pekrun G, George A, Meyer T, Bartmann U, Hillmer-Vogel U, Rüther E. Comparison of aerobic exercise, clomipramine, and placebo in the treatment of panic disorder. Am J Psychiatry. 1998 May;155(5):603-9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Severity of Panic disorder due to Scores on the Panic and Agoraphobia Scale (P&A)		Baseline to endpoint (10 weeks)
Primary	Severity of panic disorder due to scores on the Clinical Global Impression scale (CGI)		Baseline to endpoint (10 weeks)
Secondary	Symptom severity due to Hamilton Anxiety Scale (HAMA)		Baseline to endpoint (10 weeks)
Secondary	Symptom severity due to the Montgomery and Asberg depression rating scale (MADRS)		Baseline to endpoint (10 weeks)
Secondary	Response and remission analysis between groups		LOCF-analysis