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

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
University of Göttingen
ClinicalTrials.gov Identifier:
NCT00540098
First received: October 3, 2007
Last updated: October 4, 2007
Last verified: October 2007

October 3, 2007
October 4, 2007
September 2001
Not Provided
  • Severity of Panic disorder due to Scores on the Panic and Agoraphobia Scale (P&A) [ Time Frame: Baseline to endpoint (10 weeks) ]
  • Severity of panic disorder due to scores on the Clinical Global Impression scale (CGI) [ Time Frame: Baseline to endpoint (10 weeks) ]
Same as current
Complete list of historical versions of study NCT00540098 on ClinicalTrials.gov Archive Site
  • Symptom severity due to Hamilton Anxiety Scale (HAMA) [ Time Frame: Baseline to endpoint (10 weeks) ]
  • Symptom severity due to the Montgomery and Asberg depression rating scale (MADRS) [ Time Frame: Baseline to endpoint (10 weeks) ]
  • Response and remission analysis between groups [ Time Frame: LOCF-analysis ]
Same as current
Not Provided
Not Provided
 
Paroxetine vs Placebo Combined With Aerobic Exercise or Relaxation in Panic Disorder
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

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Panic Disorder
  • Drug: paroxetine + aerobic exercise
    paroxetine, 40 mg once daily + regular aerobic exercise
  • Drug: Paroxetine + relaxation
    paroxetine, 40 mg once daily + regular relaxation training
  • Drug: Placebo + aerobic exercise
    placebo pill once daily + regular aerobic exercise
  • Drug: Placebo + relaxation
    placebo pill once daily + regular relaxation training
  • Experimental: 1
    Paroxetine + aerobic exercise
    Intervention: Drug: paroxetine + aerobic exercise
  • Active Comparator: 2
    Paroxetine + relaxation
    Intervention: Drug: Paroxetine + relaxation
  • Active Comparator: 3
    Placebo + aerobic exercise
    Intervention: Drug: Placebo + aerobic exercise
  • Placebo Comparator: 4
    Placebo + relaxation
    Intervention: Drug: Placebo + relaxation
Broocks A, Bandelow B, Pekrun G, George A, Meyer T, Bartmann U, Hillmer-Vogel U, Ruther E. Comparison of aerobic exercise, clomipramine, and placebo in the treatment of panic disorder. Am J Psychiatry. 1998 May;155(5):603-9.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
75
June 2005
Not Provided

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
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00540098
290060/552
No
Not Provided
University of Göttingen
GlaxoSmithKline
Principal Investigator: Borwin Bandelow, Prof, MD University of Göttingen
University of Göttingen
October 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP