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

University of Göttingen

Status and phase: Completed; Phase 4

Conditions: Panic Disorder

Treatments: Drug: Paroxetine + relaxation; Drug: Placebo + aerobic exercise; Drug: Placebo + relaxation; Drug: paroxetine + aerobic exercise

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00540098

290060/552

Details and patient eligibility

About

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.

Full 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.

Enrollment: 75 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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75 participants in 4 patient groups, including a placebo group

1

Experimental group

Description:

Paroxetine + aerobic exercise

Treatment:

Drug: paroxetine + aerobic exercise

2

Active Comparator group

Description:

Paroxetine + relaxation

Treatment:

Drug: Paroxetine + relaxation

3

Active Comparator group

Description:

Placebo + aerobic exercise

Treatment:

Drug: Placebo + aerobic exercise

4

Placebo Comparator group

Description:

Placebo + relaxation

Treatment:

Drug: Placebo + relaxation