Desvenlafaxine vs. Placebo Treatment of Chronic Depression

Completed · Phase 4 · Has a placebo group

Conditions studied: Dysthymic Disorder, Dysthymia, Chronic Depressive Disorder

In brief

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.

Key facts

Study ID: NCT01537068
Run by: New York State Psychiatric Institute
People needed: 59
Starts: 2012-02-01
Expected to finish: 2016-12-01
Last updated by the study team: 2017-09-11

Who can join

Age: 20 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

New York State Psychiatric Institute/3 Columbus Circle Midtown — New York, New York, United States
Depression Evaluation Service (DES), New York State Psychiatric Institute, Columbia University Department of Psychiatry — New York, New York, United States

Full record on ClinicalTrials.gov

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