Desvenlafaxine Monotherapy in Dysthymia

Dysthymic Disorder Clinical Trial

Official title:

An 8-week Open-Label Flexible-Dose Study Of Desvenlafaxine as Monotherapy In The Treatment Of Dysthymia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01948895
• Other study ID #: 124/2012
• Status: Completed
• Phase: N/A
• First received: September 19, 2013
• Last updated: November 6, 2014
• Start date: August 2012
• Est. completion date: June 2014

Study information

• Verified date: November 2014
• Source: Centre for Addiction and Mental Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dysthymic Disorder

Intervention

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.

Locations

Country	Name	City	State
Canada	Medical Research Associates	Mississauga	Ontario
Canada	Centre for Addiction and Mental Health	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Centre for Addiction and Mental Health

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Montgomery-Åsberg Depression Rating Scale		8 Weeks	No
Secondary	Clinical Global Impression Scale		8 Weeks	No
Secondary	Health and Work Performance Questionnaire		Baseline, Week 8	No
Secondary	Perceived Stress Scale		Baseline, Week 8	No
Secondary	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	No
Secondary	Quick Inventory of Depressive Symptomatology		Baseline, Week 4, Week 8	No
Secondary	Survey of Coping Profiles Endorsed		Baseline, Week 4, Week 8	No
Secondary	Sheehan Disability Scale		Baseline, Week 4, Week 8	No
Secondary	Work Productivity and Activity Impairment Questionnaire		Baseline, Week 8	No

External Links

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