Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single-arm study | Experimental | Desvenlafaxine 50mg/day Desvenlafaxine 100mg/day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Desvenlafaxine | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Montgomery-Ã…sberg Depression Rating Scale | 8 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Global Impression Scale | 8 Weeks | |
| Health and Work Performance Questionnaire | Baseline, Week 8 | |
| Perceived Stress Scale |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Co-morbid diagnosis of any other Axis I disorders (other than anxiety disorders such as Generalized Anxiety Disorder, Social Anxiety Disorder and Post-traumatic Stress Disorder, provided that Dysthymic Disorder is currently the diagnosis).
Meet DSM-IV criteria for a current episode of major depression within two months prior to screening or who have received treatment for a major depressive episode within six months prior to screening.
Substance abuse or dependence including alcohol, within 6 months prior to screening.
Patients on the following prohibited treatments:
Have received physical therapies for depression (e.g. ECT, rTMS) within the 3 months prior to randomization.
Previous non-response to a therapeutic trial of desvenlafaxine (at least 50 mg/day for 2 months).
Clinically significant abnormalities in hematology, clinical chemistry, urinalysis or ECG at the screening visit, as judged by the Principal Investigator.
Presence of medical or psychiatric condition deemed by the Investigator to interfere with study procedures or endpoint data.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Arun Ravindran, MD, PhD | Centre for Addiction and Mental Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Research Associates | Mississauga | Ontario | L5M 4N4 | Canada | ||
| Centre for Addiction and Mental Health |
Not provided
| Label | URL |
|---|---|
| Information about research at the Centre for Addiction and Mental Health | View source |
Not provided
Not provided
| ID | Term |
|---|---|
| D019263 | Dysthymic Disorder |
| D001008 | Anxiety Disorders |
| D000098647 | Generalized Anxiety Disorder |
| D000072861 | Phobia, Social |
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D010698 | Phobic Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069468 | Desvenlafaxine Succinate |
| ID | Term |
|---|---|
| D003511 | Cyclohexanols |
| D000441 | Hexanols |
| D005233 | Fatty Alcohols |
| D000438 | Alcohols |
| D009930 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Baseline, Week 8 |
| Quality of Life Enjoyment and Satisfaction Scale Quality of Life Enjoyment and Satisfaction Scale Quality of Life Enjoyment and Satisfaction Questionnaire | Baseline, Week 4, Week 8 |
| Quick Inventory of Depressive Symptomatology | Baseline, Week 4, Week 8 |
| Survey of Coping Profiles Endorsed | Baseline, Week 4, Week 8 |
| Sheehan Disability Scale | Baseline, Week 4, Week 8 |
| Work Productivity and Activity Impairment Questionnaire | Baseline, Week 8 |
| Toronto |
| Ontario |
| M5T 1R8 |
| Canada |
| D040921 |
| Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| Organic Chemicals |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D008055 | Lipids |