Treatment of Panic Disorder Among Individuals Consulting Emergency Departments for Non Cardiac Chest Pain - Full Text View

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

This study is currently recruiting participants.

Verified by Universite du Quebec a Montreal, August 2008

First Received: August 14, 2008 No Changes Posted

Sponsor:	Universite du Quebec a Montreal
Collaborator:	Canadian Institutes of Health Research (CIHR)
Information provided by:	Universite du Quebec a Montreal
ClinicalTrials.gov Identifier:	NCT00736346

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:	Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
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:

MedlinePlus related topics: Anxiety Chest Pain Mental Health Panic Disorder

Drug Information available for: Paroxetine Paroxetine hydrochloride Paroxetine Mesylate

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
1: Active Comparator	Behavioral: Brief cognitive-behavioral treatment for Panic Disorder One two-hour session of cognitive-behavior therapy for panic disorder
2: Active Comparator	Behavioral: Cognitive-Behavior Therapy for Panic Disorder Seven one-hour sessions of cognitive-behavior therapy for panic disorder
3: Active Comparator	Drug: paroxetine 40 mg die, for 6 months
4: No Intervention

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
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
Hôtel-Dieu de Lévis	Recruiting
Lévis, Quebec, Canada, G6V 3Z1
Contact: Julien Poitras, 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:	UQAM ( André Marchand )
Study ID Numbers:	MOP 81128 (CIHR)
Study First Received:	August 14, 2008
Last Updated:	August 14, 2008
ClinicalTrials.gov Identifier:	NCT00736346 History of Changes
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:

Neurotransmitter Agents
Disease Attributes
Neurotransmitter Uptake Inhibitors
Disease
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Pain
Paroxetine
Serotonin Uptake Inhibitors
Pharmacologic Actions
Chest Pain

Signs and Symptoms
Panic Disorder
Serotonin Agents
Pathologic Processes
Anxiety Disorders
Mental Disorders
Therapeutic Uses
Emergencies
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on November 22, 2009