Desvenlafaxine Monotherapy in Dysthymia
|ClinicalTrials.gov Identifier: NCT01948895|
Recruitment Status : Completed
First Posted : September 24, 2013
Last Update Posted : November 7, 2014
|Condition or disease||Intervention/treatment||Phase|
|Dysthymic Disorder||Drug: Desvenlafaxine||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An 8-week Open-Label Flexible-Dose Study Of Desvenlafaxine as Monotherapy In The Treatment Of Dysthymia|
|Study Start Date :||August 2012|
|Actual Primary Completion Date :||June 2014|
|Actual Study Completion Date :||June 2014|
Experimental: Single-arm study
Desvenlafaxine 50mg/day Desvenlafaxine 100mg/day
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.
Other Name: Pristiq
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01948895
|Medical Research Associates|
|Mississauga, Ontario, Canada, L5M 4N4|
|Centre for Addiction and Mental Health|
|Toronto, Ontario, Canada, M5T 1R8|
|Principal Investigator:||Arun Ravindran, MD, PhD||Centre for Addiction and Mental Health|