Desvenlafaxine vs. Placebo Treatment of Chronic Depression
Status:
Completed
Trial end date:
2016-12-01
Target enrollment:
Participant gender:
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.