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Trial record 3 of 118 for:    Dysthymia

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

Tracking Information
First Submitted Date  ICMJE September 19, 2013
First Posted Date  ICMJE September 24, 2013
Last Update Posted Date November 7, 2014
Study Start Date  ICMJE August 2012
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 19, 2013)
Montgomery-Åsberg Depression Rating Scale [ Time Frame: 8 Weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 19, 2013)
  • 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 Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Desvenlafaxine Monotherapy in Dysthymia
Official Title  ICMJE 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 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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Dysthymic Disorder
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: Single-arm study
Desvenlafaxine 50mg/day Desvenlafaxine 100mg/day
Intervention: Drug: Desvenlafaxine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 19, 2013)
30
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2014
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01948895
Other Study ID Numbers  ICMJE 124/2012
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Arun Ravindran, Centre for Addiction and Mental Health
Study Sponsor  ICMJE Centre for Addiction and Mental Health
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Arun Ravindran, MD, PhD Centre for Addiction and Mental Health
PRS Account Centre for Addiction and Mental Health
Verification Date November 2014

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