Desvenlafaxine Monotherapy in Dysthymia
Information source: Centre for Addiction and Mental Health
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Dysthymic Disorder
Intervention: Desvenlafaxine (Drug)
Phase: N/A
Status: Completed
Sponsored by: Centre for Addiction and Mental Health Official(s) and/or principal investigator(s): Arun Ravindran, MD, PhD, Principal Investigator, Affiliation: Centre for Addiction and Mental Health
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.
Clinical Details
Official title: An 8-week Open-Label Flexible-Dose Study Of Desvenlafaxine as Monotherapy In The Treatment Of Dysthymia
Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Montgomery-Åsberg Depression Rating Scale
Secondary outcome: Clinical Global Impression ScaleHealth and Work Performance Questionnaire Perceived Stress Scale Quality of Life Enjoyment and Satisfaction Scale Quality of Life Enjoyment and Satisfaction Scale Quality of Life Enjoyment and Satisfaction Questionnaire Quick Inventory of Depressive Symptomatology Survey of Coping Profiles Endorsed Sheehan Disability Scale Work Productivity and Activity Impairment Questionnaire
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
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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.
Locations and Contacts
Medical Research Associates, Mississauga, Ontario L5M 4N4, Canada
Centre for Addiction and Mental Health, Toronto, Ontario M5T 1R8, Canada
Additional Information
Information about research at the Centre for Addiction and Mental Health
Starting date: August 2012
Last updated: November 6, 2014
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