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

Sponsor

Université du Québec a Montréal (Other)

Overall Status

Unknown status

CT.gov ID

NCT00736346

Collaborator

Canadian Institutes of Health Research (CIHR) (Other)

204

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

1.2

Patients Per Site Per Month

Study Details

Study Description

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	N/A

Study Design

Study Type:

Interventional

Anticipated 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 :

Oct 1, 2005

Anticipated Primary Completion Date :

Dec 1, 2009

Anticipated Study Completion Date :

Jun 1, 2010

Arms and Interventions

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

Primary Outcome Measures

Panic Disorder diagnosis [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 [Pre and posttreatment, and 3, 6 and 12 months after treatment]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Hôtel-Dieu de Lévis	Lévis	Quebec	Canada	G6V 3Z1
2	Institut de Cardiologie de Montréal (Montreal Heart Institute)	Montréal	Quebec	Canada	H1T 1C8
3	Hôpital du Sacré-Coeur de Montréal	Montréal	Quebec	Canada	H4J 1C5