Desvenlafaxine vs. Placebo Treatment of Chronic Depression
Condition: Dysthymic Disorder; Dysthymia; Chronic Depressive Disorder
MeSH terms: Depression; Depressive Disorder; Dysthymic Disorder
Intervention: Desvenlafaxine; Placebo
Intervention description: Desvenlafaxine oral dose ranging from 50 to 100 mg/day; Matching placebo pills
Intervention MeSH terms: Desvenlafaxine Succinate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 59.0
Sex: All
Minimum age: 20 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Dysthymic disorder; Dysthymia; Chronic non-major depression; Non-major chronic depression; Chronic depressive disorder; Antidepressant treatment

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.
    

Eligibility 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