Clinical Trial: Desvenlafaxine Monotherapy in Dysthymia

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: An 8-week Open-Label Flexible-Dose Study Of Desvenlafaxine as Monotherapy In The Treatment Of Dysthymia

Brief Summary: 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.

Detailed Summary:

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.


Sponsor: Centre for Addiction and Mental Health

Current Primary Outcome: Montgomery-Åsberg Depression Rating Scale [ Time Frame: 8 Weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome: Same as current

Information By: Centre for Addiction and Mental Health

Dates:
Date Received: September 19, 2013
Date Started: August 2012
Date Completion:
Last Updated: November 6, 2014
Last Verified: November 2014