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:

Genetics Home Reference related topics: schizophrenia

MedlinePlus related topics: Anxiety Chest Pain Panic Disorder

Drug Information available for: Paroxetine

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 (Adult, Senior)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
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


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:


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

ClinicalTrials.gov processed this record on September 26, 2016

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