Clinical trial NCT00540098: Paroxetine vs Placebo Combined With Aerobic Exercise or Relaxation in Panic Disorder
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Panic Disorder
Keywords: panic disorder
pharmacotherapy
non-pharmacological treatment
SSRI
paroxetine
exercise
Lead sponsor: University of Göttingen
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
First posted: 2007-10-05
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Severity of Panic disorder due to Scores on the Panic and Agoraphobia Scale (P&A)
timeFrame: Baseline to endpoint (10 weeks)
measure: Severity of panic disorder due to scores on the Clinical Global Impression scale (CGI)
timeFrame: Baseline to endpoint (10 weeks)
Secondary outcomes:
measure: Symptom severity due to Hamilton Anxiety Scale (HAMA)
timeFrame: Baseline to endpoint (10 weeks)
measure: Symptom severity due to the Montgomery and Asberg depression rating scale (MADRS)
timeFrame: Baseline to endpoint (10 weeks)
measure: Response and remission analysis between groups
timeFrame: LOCF-analysis
Other outcomes:
Locations:
city: Göttingen
country: Germany
facility: University of Göttingen, Dept of Psychiatry and Psychotherapy
Study officials:
affiliation: University of Göttingen
name: Borwin Bandelow, Prof, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1176/ajp.155.5.603.