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

NCT ID: NCT00540098

Last Updated: 2007-10-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-09-30

Study Completion Date

2005-06-30

Brief Summary

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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

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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.

Conditions

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Panic Disorder

Keywords

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panic disorder pharmacotherapy non-pharmacological treatment SSRI paroxetine exercise

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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1

Paroxetine + aerobic exercise

Group Type EXPERIMENTAL

paroxetine + aerobic exercise

Intervention Type DRUG

paroxetine, 40 mg once daily + regular aerobic exercise

2

Paroxetine + relaxation

Group Type ACTIVE_COMPARATOR

Paroxetine + relaxation

Intervention Type DRUG

paroxetine, 40 mg once daily + regular relaxation training

3

Placebo + aerobic exercise

Group Type ACTIVE_COMPARATOR

Placebo + aerobic exercise

Intervention Type DRUG

placebo pill once daily + regular aerobic exercise

4

Placebo + relaxation

Group Type PLACEBO_COMPARATOR

Placebo + relaxation

Intervention Type DRUG

placebo pill once daily + regular relaxation training

Interventions

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paroxetine + aerobic exercise

paroxetine, 40 mg once daily + regular aerobic exercise

Intervention Type DRUG

Paroxetine + relaxation

paroxetine, 40 mg once daily + regular relaxation training

Intervention Type DRUG

Placebo + aerobic exercise

placebo pill once daily + regular aerobic exercise

Intervention Type DRUG

Placebo + relaxation

placebo pill once daily + regular relaxation training

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role collaborator

University of Göttingen

OTHER

Sponsor Role lead

Principal Investigators

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Borwin Bandelow, Prof, MD

Role: PRINCIPAL_INVESTIGATOR

University of Göttingen

Locations

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University of Göttingen, Dept of Psychiatry and Psychotherapy

Göttingen, , Germany

Site Status

Countries

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Germany

References

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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. doi: 10.1176/ajp.155.5.603.

Reference Type BACKGROUND
PMID: 9585709 (View on PubMed)

Other Identifiers

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290060/552

Identifier Type: -

Identifier Source: org_study_id