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

Primary Purpose

Panic Disorder

Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
paroxetine + aerobic exercise
Paroxetine + relaxation
Placebo + aerobic exercise
Placebo + relaxation
Sponsored by
University of Göttingen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Panic Disorder focused on measuring panic disorder, pharmacotherapy, non-pharmacological treatment, SSRI, paroxetine, exercise

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • University of Göttingen, Dept of Psychiatry and Psychotherapy

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

1

2

3

4

Arm Description

Paroxetine + aerobic exercise

Paroxetine + relaxation

Placebo + aerobic exercise

Placebo + relaxation

Outcomes

Primary Outcome Measures

Severity of Panic disorder due to Scores on the Panic and Agoraphobia Scale (P&A)
Severity of panic disorder due to scores on the Clinical Global Impression scale (CGI)

Secondary Outcome Measures

Symptom severity due to Hamilton Anxiety Scale (HAMA)
Symptom severity due to the Montgomery and Asberg depression rating scale (MADRS)
Response and remission analysis between groups

Full Information

First Posted
October 3, 2007
Last Updated
October 4, 2007
Sponsor
University of Göttingen
Collaborators
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00540098
Brief Title
Paroxetine vs Placebo Combined With Aerobic Exercise or Relaxation in Panic Disorder
Acronym
Exparox
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2007
Overall Recruitment Status
Completed
Study Start Date
September 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Göttingen
Collaborators
GlaxoSmithKline

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Panic Disorder
Keywords
panic disorder, pharmacotherapy, non-pharmacological treatment, SSRI, paroxetine, exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Paroxetine + aerobic exercise
Arm Title
2
Arm Type
Active Comparator
Arm Description
Paroxetine + relaxation
Arm Title
3
Arm Type
Active Comparator
Arm Description
Placebo + aerobic exercise
Arm Title
4
Arm Type
Placebo Comparator
Arm Description
Placebo + relaxation
Intervention Type
Drug
Intervention Name(s)
paroxetine + aerobic exercise
Intervention Description
paroxetine, 40 mg once daily + regular aerobic exercise
Intervention Type
Drug
Intervention Name(s)
Paroxetine + relaxation
Intervention Description
paroxetine, 40 mg once daily + regular relaxation training
Intervention Type
Drug
Intervention Name(s)
Placebo + aerobic exercise
Intervention Description
placebo pill once daily + regular aerobic exercise
Intervention Type
Drug
Intervention Name(s)
Placebo + relaxation
Intervention Description
placebo pill once daily + regular relaxation training
Primary Outcome Measure Information:
Title
Severity of Panic disorder due to Scores on the Panic and Agoraphobia Scale (P&A)
Time Frame
Baseline to endpoint (10 weeks)
Title
Severity of panic disorder due to scores on the Clinical Global Impression scale (CGI)
Time Frame
Baseline to endpoint (10 weeks)
Secondary Outcome Measure Information:
Title
Symptom severity due to Hamilton Anxiety Scale (HAMA)
Time Frame
Baseline to endpoint (10 weeks)
Title
Symptom severity due to the Montgomery and Asberg depression rating scale (MADRS)
Time Frame
Baseline to endpoint (10 weeks)
Title
Response and remission analysis between groups
Time Frame
LOCF-analysis

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Borwin Bandelow, Prof, MD
Organizational Affiliation
University of Göttingen
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Göttingen, Dept of Psychiatry and Psychotherapy
City
Göttingen
ZIP/Postal Code
37075
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
9585709
Citation
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.
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Paroxetine vs Placebo Combined With Aerobic Exercise or Relaxation in Panic Disorder

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