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Desvenlafaxine Monotherapy in Dysthymia

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ClinicalTrials.gov Identifier: NCT01948895
Recruitment Status : Completed
First Posted : September 24, 2013
Last Update Posted : November 7, 2014
Sponsor:
Information provided by (Responsible Party):
Arun Ravindran, Centre for Addiction and Mental Health

September 19, 2013
September 24, 2013
November 7, 2014
August 2012
June 2014   (Final data collection date for primary outcome measure)
Montgomery-Åsberg Depression Rating Scale [ Time Frame: 8 Weeks ]
Same as current
Complete list of historical versions of study NCT01948895 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Desvenlafaxine Monotherapy in Dysthymia
An 8-week Open-Label Flexible-Dose Study Of Desvenlafaxine as Monotherapy In The Treatment Of Dysthymia
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.

Interventional
Not Applicable
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Dysthymic Disorder
Drug: Desvenlafaxine
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
Experimental: Single-arm study
Desvenlafaxine 50mg/day Desvenlafaxine 100mg/day
Intervention: Drug: Desvenlafaxine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
Same as current
June 2014
June 2014   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
 
NCT01948895
124/2012
Yes
Not Provided
Not Provided
Arun Ravindran, Centre for Addiction and Mental Health
Centre for Addiction and Mental Health
Not Provided
Principal Investigator: Arun Ravindran, MD, PhD Centre for Addiction and Mental Health
Centre for Addiction and Mental Health
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP