Status:
COMPLETED
The WORKER Study: Escitalopram and Telephone-based Cognitive Behaviour Therapy (CBT) for Depressed Working People
Lead Sponsor:
University of British Columbia
Conditions:
Major Depressive Disorder (MDD)
Eligibility:
All Genders
19-65 years
Phase:
NA
Brief Summary
This study will investigate the additional benefits of telephone-based cognitive behavioral therapy (Tel-CBT) as added treatment to an antidepressant (escitalopram) in working people with major depres...
Detailed Description
Rationale CBT is recognized as an effective psychological treatment for MDD. However, there are still considerable barriers to access CBT. Newer methods of delivering CBT, such as over the telephone (...
Eligibility Criteria
Inclusion
- Male and female outpatients aged 18-65 years.
- Patients will meet DSM-IV criteria for major depressive disorder as determined by the mood disorders section of the Mini International Neuropsychiatric Interview (MINI, Sheehan et al, 1998).
- Currently employed (or off work for 2 weeks or less, and expecting to return to work at the start of study).
- A score of 18 or greater on the self-rated version of the MADRS, indicating at least moderately severe depression.
- Competency to give informed consent.
Exclusion
- Patients on short-term (except for circumstances under Inclusion Criteria) or long-term disability.
- Pregnant women, lactating women and sexually active women of childbearing potential who are not using medically accepted means of contraception.
- Serious suicidal risks as judged by the study doctor.
- The following DSM-IV diagnoses (to ensure a homogenous diagnostic group): Organic mental disorders; Substance abuse/dependence, including alcohol, active within the last year; Schizophrenia, Paranoid or Delusional Disorders; Other Psychotic disorders; Panic disorder; Generalized Anxiety Disorder; Obsessive-Compulsive Disorder, or Post Traumatic Stress Disorder, if a primary diagnosis; Bipolar Disorder;Bulimia Nervosa; Anorexia Nervosa.
- Serious illness including cardiac, hepatic, renal, respiratory, endocrinologic, neurologic and hematologic disease that is not stabilized.
- Regular or current use of other psychotropic drugs.
- Use of monoamine oxidase inhibitors within 14 days of Visit 1, fluoxetine within 5 weeks of Visit 1, and other antidepressants within 7 days of Visit 1 (to ensure adequate drug washouts prior to starting escitalopram).
- Previous use of escitalopram.
- Treatment resistance in the current episode, as defined by failure (lack of clinically significant response) of two or more antidepressants given at therapeutic doses for at least 6 weeks.
- Patients who start formal psychotherapy (e.g. cognitive-behavioural or interpersonal psychotherapy) within 3 months of Visit 1, or who plan to initiate such psychotherapy during this study.
- Patients involved in any other form of treatment for depression.
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
105 Patients enrolled
Trial Details
Trial ID
NCT00702598
Start Date
June 1 2008
End Date
December 1 2011
Last Update
May 9 2012
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
UBC Hospital Mood Disorders Centre
Vancouver, British Columbia, Canada, V6T 2A1