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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00736346
Other study ID # MOP 81128 (CIHR)
Secondary ID
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


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
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