Desvenlafaxine Monotherapy in Dysthymia

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Arun Ravindran, Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier:
NCT01948895
First received: September 19, 2013
Last updated: March 28, 2014
Last verified: March 2014
  Purpose

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 Intervention
Dysthymic Disorder
Drug: Desvenlafaxine

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An 8-week Open-Label Flexible-Dose Study Of Desvenlafaxine as Monotherapy In The Treatment Of Dysthymia

Resource links provided by NLM:


Further study details as provided by Centre for Addiction and Mental Health:

Primary Outcome Measures:
  • Montgomery-Åsberg Depression Rating Scale [ Time Frame: 8 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical Global Impression Scale [ Time Frame: 8 Weeks ] [ Designated as safety issue: No ]
  • Health and Work Performance Questionnaire [ Time Frame: Baseline, Week 8 ] [ Designated as safety issue: No ]
  • Perceived Stress Scale [ Time Frame: Baseline, Week 8 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Quick Inventory of Depressive Symptomatology [ Time Frame: Baseline, Week 4, Week 8 ] [ Designated as safety issue: No ]
  • Survey of Coping Profiles Endorsed [ Time Frame: Baseline, Week 4, Week 8 ] [ Designated as safety issue: No ]
  • Sheehan Disability Scale [ Time Frame: Baseline, Week 4, Week 8 ] [ Designated as safety issue: No ]
  • Work Productivity and Activity Impairment Questionnaire [ Time Frame: Baseline, Week 8 ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: August 2012
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Pristiq

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01948895

Locations
Canada, Ontario
Medical Research Associates
Mississauga, Ontario, Canada, L5M 4N4
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
  More Information

Additional Information:
No publications provided

Responsible Party: Arun Ravindran, Principal Investigator, Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier: NCT01948895     History of Changes
Other Study ID Numbers: 124/2012
Study First Received: September 19, 2013
Last Updated: March 28, 2014
Health Authority: Canada: Health Canada

Keywords provided by Centre for Addiction and Mental Health:
Desvenlafaxine
Open-label
Flexible-dose
Dysthymic disorder
Anxiety disorders
Generalized anxiety disorder
Social anxiety disorder
Post-traumatic stress disorder

Additional relevant MeSH terms:
Dysthymic Disorder
Depressive Disorder
Mood Disorders
Mental Disorders
O-desmethylvenlafaxine
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 23, 2014