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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00540098
Other study ID # 290060/552
Secondary ID
Status Completed
Phase Phase 4
First received October 3, 2007
Last updated October 4, 2007
Start date September 2001
Est. completion date June 2005

Study information

Verified date October 2007
Source University of Göttingen
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 75
Est. completion date June 2005
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 60 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
paroxetine + aerobic exercise
paroxetine, 40 mg once daily + regular aerobic exercise
Paroxetine + relaxation
paroxetine, 40 mg once daily + regular relaxation training
Placebo + aerobic exercise
placebo pill once daily + regular aerobic exercise
Placebo + relaxation
placebo pill once daily + regular relaxation training

Locations

Country Name City State
Germany University of Göttingen, Dept of Psychiatry and Psychotherapy Göttingen

Sponsors (2)

Lead Sponsor Collaborator
University of Göttingen GlaxoSmithKline

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Broocks A, Bandelow B, Pekrun G, George A, Meyer T, Bartmann U, Hillmer-Vogel U, Rüther E. Comparison of aerobic exercise, clomipramine, and placebo in the treatment of panic disorder. Am J Psychiatry. 1998 May;155(5):603-9. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Severity of Panic disorder due to Scores on the Panic and Agoraphobia Scale (P&A) Baseline to endpoint (10 weeks)
Primary Severity of panic disorder due to scores on the Clinical Global Impression scale (CGI) Baseline to endpoint (10 weeks)
Secondary Symptom severity due to Hamilton Anxiety Scale (HAMA) Baseline to endpoint (10 weeks)
Secondary Symptom severity due to the Montgomery and Asberg depression rating scale (MADRS) Baseline to endpoint (10 weeks)
Secondary Response and remission analysis between groups LOCF-analysis
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