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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
75
paroxetine, 40 mg once daily + regular aerobic exercise
paroxetine, 40 mg once daily + regular relaxation training
placebo pill once daily + regular aerobic exercise
University of Göttingen, Dept of Psychiatry and Psychotherapy
Göttingen, Germany
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)
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
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placebo pill once daily + regular relaxation training