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.

Study Overview

• Status: Completed
• Conditions: Dysthymic Disorder
• Intervention / Treatment: Drug: Desvenlafaxine

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: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Mississauga, Ontario, Canada, L5M 4N4
      • Medical Research Associates
    • Toronto, Ontario, Canada, M5T 1R8
      • Centre for Addiction and Mental Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Montgomery-Åsberg Depression Rating Scale	8 Weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Clinical Global Impression Scale	8 Weeks
Health and Work Performance Questionnaire	Baseline, Week 8
Perceived Stress Scale	Baseline, Week 8
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
Quick Inventory of Depressive Symptomatology	Baseline, Week 4, Week 8
Survey of Coping Profiles Endorsed	Baseline, Week 4, Week 8
Sheehan Disability Scale	Baseline, Week 4, Week 8
Work Productivity and Activity Impairment Questionnaire	Baseline, Week 8

Collaborators and Investigators

• Sponsor: Centre for Addiction and Mental Health

Publications and helpful links

Helpful Links

• Information about research at the Centre for Addiction and Mental Health

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: September 19, 2013
• First Submitted That Met QC Criteria: September 19, 2013
• First Posted (Estimate): September 24, 2013

Study Record Updates

• Last Update Posted (Estimate): November 7, 2014
• Last Update Submitted That Met QC Criteria: November 6, 2014
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Keywords: Open-label; Anxiety disorders; Desvenlafaxine; Post-traumatic stress disorder; Social anxiety disorder; Generalized anxiety disorder; Flexible-dose; Dysthymic disorder
• Additional Relevant MeSH Terms: Mental Disorders; Mood Disorders; Depressive Disorder; Dysthymic Disorder; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Psychotropic Drugs; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Antidepressive Agents; Serotonin and Noradrenaline Reuptake Inhibitors; Desvenlafaxine Succinate
• Other Study ID Numbers: 124/2012