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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 Scale

Health 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

Page last updated: August 23, 2015

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