Major Depressive Disorder
Conditions
Keywords
depression, cognition, occupational functioning, productivity, neuropsychology, desvenlafaxine, antidepressants
Brief summary
This study will investigate the relationships between subjective cognitive complaints, neurocognitive deficits, and work productivity in participants with Major Depressive Disorder (MDD), before and after 8 weeks of treatment with an antidepressant medication. Our hypothesis is that, in working participants with MDD of at least moderate severity, neurocognitive deficits will predict poorer work functioning and productivity.
Interventions
DRUGdesvenlafaxine
50-100 mg daily for 8 weeks
Sponsors
Pfizer
University of British Columbia
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
1. Clinical diagnosis of Major Depressive Disorder as per DSM-IV-TR 2. Current employment of at least 15 hours per week 3. Baseline score of 23 or greater on the Montgomery-Asberg Depression Rating Scale, indicating at least moderately severe depression 4. Baseline score of 6 or greater on the British Columbia Cognitive Complaints Inventory, indicating at least moderate subjective cognitive complaints 5. Competency to give informed consent
Exclusion criteria
1. Current receipt of short-term or long-term disability benefits from employer 2. Serious suicidal risks as judged by the investigators 3. Other DSM-IV-TR diagnoses: 1. organic mental disorders 2. active substance abuse/dependence, including alcohol 3. schizophrenia, paranoid or delusional disorders, or other psychotic disorders 4. (as primary diagnosis:) panic disorder, generalized anxiety disorder, obsessive-compulsive disorder, or post-traumatic stress disorder 5. bipolar disorder 6. bulimia nervosa or anorexia nervosa 4. Serious illness that is not stabilized, including cardiac, hepatic, renal, respiratory, endocrinologic, neurologic, or hematologic disease 5. Regular/current use of other psychotropic drugs and/or herbaceuticals 6. Use of fluoxetine within 5 weeks of Visit 1, monoamine oxidase inhibitors within 14 days of Visit 1, and other antidepressants within 7 days of Visit 1 (all to ensure adequate drug washouts prior to neurocognitive assessment) 7. Previous treatment with desvenlafaxine 8. Treatment-resistance in the current episode, as defined by failure (i.e., lack of clinically significant response) of 2 or more antidepressants given at therapeutic doses for at least 6 weeks 9. Any history of treatment with electroconvulsive therapy 10. Initiation of formal psychotherapy (e.g., cognitive-behavioural therapy or interpersonal psychotherapy) with 2 months of Visit 1, or plans to start such psychotherapy during this study 11. Current use of any other form of treatment for depression
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| cognitive functioning as determined by neuropsychological testing | change from baseline to 8 weeks | Neuropsychological testing in 5 domains (memory, psychomotor speed, reaction time, cognitive flexibility, and complex attention) is conducted using computerized measures, both at baseline and after 8 weeks of standard medical care involving antidepressant medication (flexibly-dosed desvenlafaxine) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| work productivity as determined by rating scales | change from baseline to 8 weeks | Work functioning (attendance and productivity) is assessed using subjective and objective measures, both at baseline and after 8 weeks of standard medical care involving antidepressant medication (flexibly-dosed desvenlafaxine) |
Countries
Canada
Outcome results
None listed