Dysthymic Disorder Clinical Trial
Official title:
An 8-week Open-Label Flexible-Dose Study Of Desvenlafaxine as Monotherapy In The Treatment Of Dysthymia
Verified date | November 2014 |
Source | Centre for Addiction and Mental Health |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Health Canada |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 30 |
Est. completion date | June 2014 |
Est. primary completion date | June 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Male and female patients between 18-65 years. - Primary diagnosis of Dysthymic Disorder, as defined by DSM-IV criteria (300.4). - MADRS score =15 at Screening and Baseline. - Supportive therapy, and use of zopiclone for sleep and low-dose benzodiazepines on an as needed basis for anxiety, is allowed at any time. - Written informed consent 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: 1. Psychotropics such as other SSRIs, other SNRIs, lithium, sibutramine, tramadol, St. John's Wort, within 2 weeks of randomization 2. Agents that impact significantly on serotonin metabolism (e.g. MAOIs, tryptophan, triptans) within 2 weeks of randomization - 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. |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | Medical Research Associates | Mississauga | Ontario |
Canada | Centre for Addiction and Mental Health | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
Centre for Addiction and Mental Health |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Montgomery-Åsberg Depression Rating Scale | 8 Weeks | No | |
Secondary | Clinical Global Impression Scale | 8 Weeks | No | |
Secondary | Health and Work Performance Questionnaire | Baseline, Week 8 | No | |
Secondary | Perceived Stress Scale | Baseline, Week 8 | No | |
Secondary | 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 | No | |
Secondary | Quick Inventory of Depressive Symptomatology | Baseline, Week 4, Week 8 | No | |
Secondary | Survey of Coping Profiles Endorsed | Baseline, Week 4, Week 8 | No | |
Secondary | Sheehan Disability Scale | Baseline, Week 4, Week 8 | No | |
Secondary | Work Productivity and Activity Impairment Questionnaire | Baseline, Week 8 | No |
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