Paroxetine vs Placebo Combined With Aerobic Exercise or Relaxation in Panic Disorder - Tabular View

Tracking Information

First Received Date ^ICMJE

October 3, 2007

Last Updated Date

October 4, 2007

Start Date ^ICMJE

September 2001

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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) ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00540098 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Caregiver, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Panic Disorder

Intervention ^ICMJE

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

Study Arms / Comparison Groups

Experimental: Paroxetine + aerobic exercise
Active Comparator: Paroxetine + relaxation
Active Comparator: Placebo + aerobic exercise
Placebo Comparator: Placebo + relaxation

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.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

June 2005

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 60 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany

Administrative Information

NCT ID ^ICMJE

NCT00540098

Responsible Party

Study ID Numbers ^ICMJE

290060/552

Study Sponsor ^ICMJE

University of Göttingen

Collaborators ^ICMJE

GlaxoSmithKline

Investigators ^ICMJE

Principal Investigator:

Borwin Bandelow, Prof, MD

University of Göttingen

Information Provided By

University of Göttingen

Verification Date

October 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP