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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2008 by Universite du Quebec a Montreal.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by:
Universite du Quebec a Montreal
ClinicalTrials.gov Identifier:
NCT00736346
First received: August 14, 2008
Last updated: NA
Last verified: August 2008
History: No changes posted
  Purpose

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.


Condition Intervention
Panic Disorder
Anxiety Disorder
Mental Disorder
 Behavioral: Brief cognitive-behavioral treatment for Panic Disorder
Behavioral: Cognitive-Behavior Therapy for Panic Disorder
Drug: paroxetine

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy of Three Treatment Modalities for Panic Disorder Among Individuals Consulting Emergency Departments for Non Cardiac Chest Pain

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Universite du Quebec a Montreal:

Primary Outcome Measures:
  • Panic Disorder diagnosis [ Time Frame: Pre and posttreatment, and 3, 6 and 12 months after treament ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 204
Study Start Date: October 2005
Estimated Study Completion Date: June 2010
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00736346

Contacts
Contact: André Marchand, PhD 1 (514) 987-3000 ext 8439 marchand.andre@uqam.ca
Contact: Geneviève Belleville, PhD belleville.genevieve@uqam.ca

Locations
Canada, Quebec
Hôtel-Dieu de Lévis Recruiting
Lévis, Quebec, Canada, G6V 3Z1
Contact: Julien Poitras, MD            
Hôpital du Sacré-Coeur de Montréal Recruiting
Montréal, Quebec, Canada, H4J 1C5
Contact: Jean-Marc Chauny, MD            
Institut de Cardiologie de Montréal (Montreal Heart Institute) Recruiting
Montréal, Quebec, Canada, H1T 1C8
Contact: Alain Vadeboncoeur, MD            
Sponsors and Collaborators
Universite du Quebec a Montreal
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: André Marchand, PhD Universite du Quebec a Montreal
  More Information

No publications provided

Responsible Party: André Marchand, UQAM
ClinicalTrials.gov Identifier: NCT00736346     History of Changes
Other Study ID Numbers: MOP 81128 (CIHR)
Study First Received: August 14, 2008
Last Updated: August 14, 2008
Health Authority: Canada: Health Canada

Keywords provided by Universite du Quebec a Montreal:
Panic Disorder
anxiety
chest pain
emergency department
cognitive-behavioral treatment

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders
Psychotic Disorders
Chest Pain
Emergencies
Panic Disorder
Schizophrenia and Disorders with Psychotic Features
Pain
Signs and Symptoms
Disease Attributes
Pathologic Processes
Paroxetine
 Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 21, 2013