NCT00540098

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Sep 2001

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2001

Completed
3.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2005

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

October 3, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 5, 2007

Completed
Last Updated

October 5, 2007

Status Verified

October 1, 2007

First QC Date

October 3, 2007

Last Update Submit

October 4, 2007

Conditions

Panic Disorder

Keywords

panic disorderpharmacotherapynon-pharmacological treatmentSSRIparoxetineexercise

Outcome Measures

Primary Outcomes (2)

  • Severity of Panic disorder due to Scores on the Panic and Agoraphobia Scale (P&A)

    Baseline to endpoint (10 weeks)

  • Severity of panic disorder due to scores on the Clinical Global Impression scale (CGI)

    Baseline to endpoint (10 weeks)

Secondary Outcomes (3)

  • Symptom severity due to Hamilton Anxiety Scale (HAMA)

    Baseline to endpoint (10 weeks)

  • Symptom severity due to the Montgomery and Asberg depression rating scale (MADRS)

    Baseline to endpoint (10 weeks)

  • Response and remission analysis between groups

    LOCF-analysis

Study Arms (4)

1

EXPERIMENTAL

Paroxetine + aerobic exercise

Drug: paroxetine + aerobic exercise

2

ACTIVE COMPARATOR

Paroxetine + relaxation

Drug: Paroxetine + relaxation

3

ACTIVE COMPARATOR

Placebo + aerobic exercise

Drug: Placebo + aerobic exercise

4

PLACEBO COMPARATOR

Placebo + relaxation

Drug: Placebo + relaxation

Interventions

paroxetine + aerobic exerciseDRUG

paroxetine, 40 mg once daily + regular aerobic exercise

1
Paroxetine + relaxationDRUG

paroxetine, 40 mg once daily + regular relaxation training

2
Placebo + aerobic exerciseDRUG

placebo pill once daily + regular aerobic exercise

3
Placebo + relaxationDRUG

placebo pill once daily + regular relaxation training

4

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Göttingen, Dept of Psychiatry and Psychotherapy

Göttingen, 37075, Germany

Location

Related Publications (1)

  • 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.

    PMID: 9585709BACKGROUND

MeSH Terms

Conditions

Panic DisorderMotor Activity

Interventions

ParoxetineExercise

Condition Hierarchy (Ancestors)

Anxiety DisordersMental DisordersBehavior

Intervention Hierarchy (Ancestors)

PiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Borwin Bandelow, Prof, MD

    University of Göttingen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 3, 2007

First Posted

October 5, 2007

Study Start

September 1, 2001

Study Completion

June 1, 2005

Last Updated

October 5, 2007

Record last verified: 2007-10

Locations

DE(1)