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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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 or disease	Intervention/treatment	Phase
Panic Disorder; Anxiety Disorder; Mental Disorder	Behavioral: Brief cognitive-behavioral treatment for Panic Disorder; Behavioral: Cognitive-Behavior Therapy for Panic Disorder; Drug: paroxetine	Not Applicable

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	204 participants
Allocation:	Non-Randomized
Intervention Model:	Parallel Assignment
Masking:	None (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
Study Start Date :	October 2005
Estimated Primary Completion Date :	December 2009
Estimated Study Completion Date :	June 2010

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Panic Disorder diagnosis [ Time Frame: Pre and posttreatment, and 3, 6 and 12 months after treament ]

Secondary Outcome Measures :

1. 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 ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Institut de Cardiologie de Montréal (Montreal Heart Institute)	Recruiting
Montréal, Quebec, Canada, H1T 1C8
Contact: Alain Vadeboncoeur, MD
Hôpital du Sacré-Coeur de Montréal	Recruiting
Montréal, Quebec, Canada, H4J 1C5
Contact: Jean-Marc Chauny, 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

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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Foldes-Busque G, Hamel S, Belleville G, Fleet R, Poitras J, Chauny JM, Vadeboncoeur A, Lavoie KL, Marchand A. Factors associated with pain level in non-cardiac chest pain patients with comorbid panic disorder. Biopsychosoc Med. 2016 Oct 18;10:30. eCollection 2016.

Responsible Party:	André Marchand, UQAM
ClinicalTrials.gov Identifier:	NCT00736346 History of Changes
Other Study ID Numbers:	MOP 81128 (CIHR)
First Posted:	August 15, 2008
Last Update Posted:	August 15, 2008
Last Verified:	August 2008

Keywords provided by Universite du Quebec a Montreal:

Panic Disorder; anxiety; chest pain; emergency department; cognitive-behavioral treatment

Additional relevant MeSH terms:

Disease; Emergencies; Anxiety Disorders; Chest Pain; Mental Disorders; Psychotic Disorders; Panic Disorder; Pathologic Processes; Disease Attributes; Pain; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Schizophrenia Spectrum and Other Psychotic Disorders

Paroxetine; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Neurotransmitter Agents; Serotonin Agents; Physiological Effects of Drugs; Antidepressive Agents, Second-Generation; Antidepressive Agents; Psychotropic Drugs; Cytochrome P-450 CYP2D6 Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Enzyme Inhibitors