Dysthymic Disorder Clinical Trial
Official title:
Desvenlafaxine (Pristiq) vs. Placebo in the Treatment of Chronic Depression
Verified date | September 2017 |
Source | New York State Psychiatric Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 59 |
Est. completion date | December 2016 |
Est. primary completion date | August 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 65 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Depression Evaluation Service (DES), New York State Psychiatric Institute, Columbia University Department of Psychiatry | New York | New York |
United States | New York State Psychiatric Institute/3 Columbus Circle Midtown | New York | New York |
Lead Sponsor | Collaborator |
---|---|
New York State Psychiatric Institute | Pfizer |
United States,
DeMartinis NA, Yeung PP, Entsuah R, Manley AL. A double-blind, placebo-controlled study of the efficacy and safety of desvenlafaxine succinate in the treatment of major depressive disorder. J Clin Psychiatry. 2007 May;68(5):677-88. — View Citation
Levkovitz Y, Tedeschini E, Papakostas GI. Efficacy of antidepressants for dysthymia: a meta-analysis of placebo-controlled randomized trials. J Clin Psychiatry. 2011 Apr;72(4):509-14. doi: 10.4088/JCP.09m05949blu. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Hamilton Rating Scale for Depression (HDRS24) | HDRS-24 total score, standardly used rating scale for depression. Score 0-7 no depression; Score 8-16 mild depression; Score 17-23 moderate depression; Score 24 and up severe depression. Range= 0 to 75, higher score=worse depression | Baseline | |
Primary | Hamilton Rating Scale for Depression (HDRS24) | HDRS-24 total score, standardly used rating scale for depression. Score 0-7 no depression; Score 8-16 mild depression; Score 17-23 moderate depression; Score 24 and up severe depression. Range= 0 to 75, higher score=worse depression | Week 12 | |
Secondary | Response Rate | Assessment of overall improvement: based on HDRS and Clinical Global Improvement Scale Response Rate is defined as 50% improvement of Hamd24 summary scores from baseline. | 12 weeks |
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