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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. The completion date has passed and the status has not been verified in more than two years.
Verified August 2008 by Universite du Quebec a Montreal.
Recruitment status was: Recruiting
Recruitment status was: Recruiting
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
First received: August 14, 2008
Last updated: NA
Last verified: August 2008
History: No changes posted
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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 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 |
Resource links provided by NLM:
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 ]
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 ]
| 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) |
| 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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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
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
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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 |
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 August 22, 2017