Treatment of Panic Disorder Among Individuals Consulting Emergency Departments for Non Cardiac Chest Pain (MADONA)

August 14, 2008 updated by: Université du Québec a Montréal

Efficacy of Three Treatment Modalities for Panic Disorder Among Individuals Consulting Emergency Departments for Non Cardiac Chest Pain

The purpose of this study is to assess the impact of three different treatment modalities on panic symptoms, quality of life and use of health services among individuals consulting an emergency department for non cardiac chest pain and having Panic Disorder.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

204

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Lévis, Quebec, Canada, G6V 3Z1
        • Recruiting
        • Hotel-Dieu de Levis
        • Contact:
          • Julien Poitras, MD
      • Montréal, Quebec, Canada, H4J 1C5
        • Recruiting
        • Hopital Du Sacre-Coeur de Montreal
        • Contact:
          • Jean-Marc Chauny, MD
      • Montréal, Quebec, Canada, H1T 1C8
        • Recruiting
        • Institut de Cardiologie de Montreal (Montreal Heart Institute)
        • Contact:
          • Alain Vadeboncoeur, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Aged 18 and over
  • Mastered oral and written French
  • Consulted an emergency department for chest pain with very low risk of coronary disease (normal ECG and blood tests)
  • Met criteria for Panic Disorder

Exclusion Criteria:

  • Chest pain with an obvious medical origin (obvious trauma or abnormal pulmonary x-rays)
  • Had received cognitive-behavior therapy for Panic Disorder in the last six months
  • Cognitive impairment preventing the completion of psychological assessment
  • Past or present psychotic episode, Bipolar Disorder, or organic mental disorder
  • Current Abuse or Dependence Disorder
  • If another Mental Disorder is present, its severity was equal or inferior to the severity of Panic Disorder
  • Current medical condition preventing the participant from receiving pharmacological of cognitive-behavior treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 1
Behavioral: Brief cognitive-behavioral treatment for Panic Disorder
One two-hour session of cognitive-behavior therapy for panic disorder
ACTIVE_COMPARATOR: 2
Behavioral: Cognitive-Behavior Therapy for Panic Disorder
Seven one-hour sessions of cognitive-behavior therapy for panic disorder
ACTIVE_COMPARATOR: 3
Drug: paroxetine
40 mg die, for 6 months
NO_INTERVENTION: 4

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Panic Disorder diagnosis
Time Frame: Pre and posttreatment, and 3, 6 and 12 months after treament
Pre and posttreatment, and 3, 6 and 12 months after treament

Secondary Outcome Measures

Outcome Measure
Time Frame
Panic symptomatology, psychological distress, quality of life, and use of health services
Time Frame: Pre and posttreatment, and 3, 6 and 12 months after treatment
Pre and posttreatment, and 3, 6 and 12 months after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Université du Québec a Montréal

Collaborators

Canadian Institutes of Health Research (CIHR)

Investigators

  • Principal Investigator: André Marchand, PhD, Université du Québec a Montréal

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2005

Primary Completion (ANTICIPATED)

December 1, 2009

Study Completion (ANTICIPATED)

June 1, 2010

Study Registration Dates

First Submitted

August 14, 2008

First Submitted That Met QC Criteria

August 14, 2008

First Posted (ESTIMATE)

August 15, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

August 15, 2008

Last Update Submitted That Met QC Criteria

August 14, 2008

Last Verified

August 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MOP 81128 (CIHR)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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