Desvenlafaxine vs. Placebo Treatment of Chronic Depression

• Status: Completed
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The investigators are studying a new antidepressant medicine, desvenlafaxine, for the treatment of people with chronic depression. Desvenlafaxine (trade name Pristiq) has been approved by the FDA for the treatment of major depression.

The investigators are testing whether this medicine is also effective for adults with a type of chronic depression that is less severe than major depression. This condition is also known as dysthymic disorder or dysthymia. Chronic depression, lasting two or more years, often causes significant suffering and impairment.

In addition, the investigators are using MRI imaging, which uses magnetic signals to make pictures of the brain's structure and also of its functioning. The purpose of MRI imaging in this study is to see whether chronic depression is associated with differences in brain structure or functioning, and whether such differences change after medication or placebo treatment. To test this MRI scans are done at the start of the study and after 12 weeks of medication or placebo treatment. Getting MRI imaging will be an option for participants in this study but is not required.

This study involves a 6 to 12 week double-blind period during which half of the participants will take the new medication and half will take a placebo (an inactive look-alike pill). After the double blind phase, all subjects can be treated for 12 weeks with an FDA-approved antidepressant medication.

Assessments (of depressive symptoms, social functioning, and personality) will be done by study staff and by patients before the study starts, at each study visit for the first 12 weeks, and again after 24 weeks in the study.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: New York State Psychiatric Institute
• Collaborator: Pfizer
• Treatments: Desvenlafaxine Succinate

Criteria

Inclusion Criteria:

• Male and female outpatients 20 to 65 years of age, inclusive

• Principal DSM-5 diagnosis of unipolar non-major Chronic Depressive Disorder (including Major Depression in partial remission, Major Depression, residual, Dysthymic Disorder, or Depressive Disorder NOS)

• Minimum of 2 years duration of the current episode of depressive disorder.

• Score of 12 or higher on the Hamilton Depression Scale (24 items) at baseline

Exclusion Criteria:

• Full remission of depression in past 24 months

• Current major depression diagnosis, psychotic illness

• Current risk of suicide

• Drug or alcohol abuse/dependence in past 6 months

• Active medical illness

• Prior nonresponse to desvenlafaxine

• Medical illness contraindicating use of desvenlafaxine

• Current or planned pregnancy during study period