Paroxetine vs Placebo Combined With Aerobic Exercise or Relaxation in Panic Disorder
Information source: University of G÷ttingen
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Panic Disorder
Intervention: paroxetine + aerobic exercise (Drug); Paroxetine + relaxation (Drug); Placebo + aerobic exercise (Drug); Placebo + relaxation (Drug)
Phase: Phase 4
Sponsored by: University of G÷ttingen
Official(s) and/or principal investigator(s):
Borwin Bandelow, Prof, MD, Principal Investigator, Affiliation: University of G├Âttingen
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
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
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Severity of Panic disorder due to Scores on the Panic and Agoraphobia Scale (P&A)
Severity of panic disorder due to scores on the Clinical Global Impression scale (CGI)
Symptom severity due to Hamilton Anxiety Scale (HAMA)
Symptom severity due to the Montgomery and Asberg depression rating scale (MADRS)
Response and remission analysis between groups
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
Minimum age: 18 Years.
Maximum age: 60 Years.
- 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)
- 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
- psychotropic medication other than promethazine
- current psychological treatment
- unable to perform regular aerobic exercise
Locations and Contacts
University of G├Âttingen, Dept of Psychiatry and Psychotherapy, G├Âttingen 37075, Germany
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.
Starting date: September 2001
Ending date: June 2005
Last updated: October 4, 2007