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

Sponsors and Collaborators:	University of Göttingen GlaxoSmithKline
Information provided by:	University of Göttingen
ClinicalTrials.gov Identifier:	NCT00540098

Purpose

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.

Condition	Intervention	Phase
Panic Disorder	Drug: paroxetine + aerobic exercise Drug: Paroxetine + relaxation Drug: Placebo + aerobic exercise Drug: Placebo + relaxation	Phase IV

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

Resource links provided by NLM:

MedlinePlus related topics: Exercise and Physical Fitness Panic Disorder

Drug Information available for: Paroxetine Paroxetine hydrochloride Paroxetine Mesylate

U.S. FDA Resources

Further study details as provided by University of Göttingen:

Primary Outcome Measures:

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) ]

Secondary Outcome Measures:

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 ]

Enrollment:	75
Study Start Date:	September 2001
Study Completion Date:	June 2005

Arms	Assigned Interventions
1: Experimental Paroxetine + aerobic exercise	Drug: paroxetine + aerobic exercise paroxetine, 40 mg once daily + regular aerobic exercise
2: Active Comparator Paroxetine + relaxation	Drug: Paroxetine + relaxation paroxetine, 40 mg once daily + regular relaxation training
3: Active Comparator Placebo + aerobic exercise	Drug: Placebo + aerobic exercise placebo pill once daily + regular aerobic exercise
4: Placebo Comparator Placebo + relaxation	Drug: Placebo + relaxation placebo pill once daily + regular relaxation training

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

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00540098

Locations

Germany
University of Göttingen, Dept of Psychiatry and Psychotherapy
Göttingen, Germany, 37075

Sponsors and Collaborators

University of Göttingen

GlaxoSmithKline

Investigators

Principal Investigator:

Borwin Bandelow, Prof, MD

University of Göttingen

More Information

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.

Study ID Numbers:	290060/552
Study First Received:	October 3, 2007
Last Updated:	October 4, 2007
ClinicalTrials.gov Identifier:	NCT00540098 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Göttingen:

panic disorder
pharmacotherapy
non-pharmacological treatment

SSRI
paroxetine
exercise

Study placed in the following topic categories:

Neurotransmitter Agents
Panic Disorder
Anxiety Disorders
Mental Disorders
Psychotropic Drugs

Antidepressive Agents, Second-Generation
Serotonin Uptake Inhibitors
Paroxetine
Antidepressive Agents
Serotonin

Additional relevant MeSH terms:

Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Disease
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Paroxetine
Serotonin Uptake Inhibitors
Pharmacologic Actions

Panic Disorder
Pathologic Processes
Serotonin Agents
Anxiety Disorders
Mental Disorders
Therapeutic Uses
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on July 02, 2009