Desvenlafaxine Monotherapy in Dysthymia

Sponsor
Centre for Addiction and Mental Health (Other)
Overall Status
Completed
CT.gov ID
NCT01948895
Collaborator
(none)
30
2
1
22
15
0.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An 8-week Open-Label Flexible-Dose Study Of Desvenlafaxine as Monotherapy In The Treatment Of Dysthymia
Study Start Date :
Aug 1, 2012
Actual Primary Completion Date :
Jun 1, 2014
Actual Study Completion Date :
Jun 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: Single-arm study

Desvenlafaxine 50mg/day Desvenlafaxine 100mg/day

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 Names:
  • Pristiq
  • Outcome Measures

    Primary Outcome Measures

    1. Montgomery-Åsberg Depression Rating Scale [8 Weeks]

    Secondary Outcome Measures

    1. Clinical Global Impression Scale [8 Weeks]

    2. Health and Work Performance Questionnaire [Baseline, Week 8]

    3. Perceived Stress Scale [Baseline, Week 8]

    4. 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]

    5. Quick Inventory of Depressive Symptomatology [Baseline, Week 4, Week 8]

    6. Survey of Coping Profiles Endorsed [Baseline, Week 4, Week 8]

    7. Sheehan Disability Scale [Baseline, Week 4, Week 8]

    8. Work Productivity and Activity Impairment Questionnaire [Baseline, Week 8]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Medical Research Associates Mississauga Ontario Canada L5M 4N4
    2 Centre for Addiction and Mental Health Toronto Ontario Canada M5T 1R8

    Sponsors and Collaborators

    • Centre for Addiction and Mental Health

    Investigators

    • Principal Investigator: Arun Ravindran, MD, PhD, Centre for Addiction and Mental Health

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Arun Ravindran, Principal Investigator, Centre for Addiction and Mental Health
    ClinicalTrials.gov Identifier:
    NCT01948895
    Other Study ID Numbers:
    • 124/2012
    First Posted:
    Sep 24, 2013
    Last Update Posted:
    Nov 7, 2014
    Last Verified:
    Nov 1, 2014
    Keywords provided by Arun Ravindran, Principal Investigator, Centre for Addiction and Mental Health
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 7, 2014