Paroxetine vs Placebo Combined With Aerobic Exercise or Relaxation in Panic Disorder
Information source: University of Göttingen
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
Status: Completed
Sponsored by: University of Göttingen Official(s) and/or principal investigator(s):
Borwin Bandelow, Prof, MD, Principal Investigator, Affiliation: University of Göttingen
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.
Clinical Details
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
Primary outcome: 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)
Secondary outcome: 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
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 60 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
University of Göttingen, Dept of Psychiatry and Psychotherapy, Göttingen 37075, Germany
Additional Information
Related publications: 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
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