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

Panic Disorder Clinical Trial

— MADONA  

Official title:

Efficacy of Three Treatment Modalities for Panic Disorder Among Individuals Consulting Emergency Departments for Non Cardiac Chest Pain

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00736346
• Other study ID #: MOP 81128 (CIHR)
• Status: Recruiting
• Phase: N/A
• First received: August 14, 2008
• Last updated: August 14, 2008
• Start date: October 2005
• Est. completion date: June 2010

Study information

• Verified date: August 2008
• Source: Universite du Quebec a Montreal
• Contact: André Marchand, PhD
• Phone: 1 (514) 987-3000
• Email: marchand.andre[@]uqam.ca
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 204
• Est. completion date: June 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety Disorder
• Anxiety Disorders
• Chest Pain
• Disease
• Emergencies
• Mental Disorder
• Mental Disorders
• Panic Disorder
• Psychotic Disorders

Intervention

Behavioral:
• Brief cognitive-behavioral treatment for Panic Disorder
One two-hour session of cognitive-behavior therapy for panic disorder
• Cognitive-Behavior Therapy for Panic Disorder
Seven one-hour sessions of cognitive-behavior therapy for panic disorder

Drug:
• paroxetine
40 mg die, for 6 months

Locations

Country	Name	City	State
Canada	Hôtel-Dieu de Lévis	Lévis	Quebec
Canada	Hôpital du Sacré-Coeur de Montréal	Montréal	Quebec
Canada	Institut de Cardiologie de Montréal (Montreal Heart Institute)	Montréal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Universite du Quebec a Montreal	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Panic Disorder diagnosis		Pre and posttreatment, and 3, 6 and 12 months after treament	No
Secondary	Panic symptomatology, psychological distress, quality of life, and use of health services		Pre and posttreatment, and 3, 6 and 12 months after treatment	No