Ignite Creation Date:
2025-12-24 @ 1:56 PM
Ignite Modification Date:
2026-01-04 @ 3:45 AM
Study NCT ID:
NCT01948895
Status:
COMPLETED
Last Update Posted:
2014-11-07
First Post:
2013-09-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Desvenlafaxine Monotherapy in Dysthymia
Sponsor:
Centre for Addiction and Mental Health
Organization:
Study Overview
Official Title:
An 8-week Open-Label Flexible-Dose Study Of Desvenlafaxine as Monotherapy In The Treatment Of Dysthymia
Status:
COMPLETED
Status Verified Date:
2014-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Description:
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: