This multi-centred study will be conducted at two centres. The design will be an open label, flexible-dose study. This investigation will evaluate the efficacy of Desvenlafaxine monotherapy for patients who meet diagnostic criteria for dysthymia.
Primary objective: To investigate the efficacy, safety, and tolerability of open-label desvenlafaxine monotherapy in dysthymic subjects. Secondary objectives: To evaluate the efficacy of desvenlafaxine on clinical measures relating to improvement of depressive symptoms, quality of life and occupational functioning. It is hypothesized that Dysthymic subjects will show significant improvement in depressive symptoms after 8 weeks of treatment with desvenlafaxine. There will be significant improvement in measures of quality of life and stress coping at end of treatment, compared to Baseline. There will also be significant improvement in measures of occupational functioning at end of treatment, compared to Baseline.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Patients will be initiated on 50 mg/day of Desvenlafaxine. No dose changes will be allowed for the first four weeks. If there is partial or no response after four weeks, dosage will then be increased to 100mg/day, based on tolerability and the Investigator's judgment.
Medical Research Associates
Mississauga, Ontario, Canada
Centre for Addiction and Mental Health
Toronto, Ontario, Canada
Montgomery-Åsberg Depression Rating Scale
Time frame: 8 Weeks
Clinical Global Impression Scale
Time frame: 8 Weeks
Health and Work Performance Questionnaire
Time frame: Baseline, Week 8
Perceived Stress Scale
Time frame: Baseline, Week 8
Quality of Life Enjoyment and Satisfaction Scale Quality of Life Enjoyment and Satisfaction Scale Quality of Life Enjoyment and Satisfaction Questionnaire
Time frame: Baseline, Week 4, Week 8
Quick Inventory of Depressive Symptomatology
Time frame: Baseline, Week 4, Week 8
Survey of Coping Profiles Endorsed
Time frame: Baseline, Week 4, Week 8
Sheehan Disability Scale
Time frame: Baseline, Week 4, Week 8
Work Productivity and Activity Impairment Questionnaire
Time frame: Baseline, Week 8
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