Desvenlafaxine Monotherapy in Dysthymia

• Status: Completed
• Trial end date: 2014-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre for Addiction and Mental Health
• Treatments: Desvenlafaxine Succinate

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.