Status:
COMPLETED
Study of 6(S)-5-MTHF Among Selective Serotonin Reuptake Inhibitor-Resistant Outpatients With Major Depressive Disorder
Lead Sponsor:
George I. Papakostas
Collaborating Sponsors:
Pamlab, L.L.C.
Conditions:
Depression
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
The purpose of the study is to test whether oral 6(S)-5-MTHF (Deplin) is safe and effective in relieving depression when it is added to standard kinds of antidepressants called serotonin reuptake inhi...
Detailed Description
The study consists of two phases, each lasting a total of four weeks (8 weeks total), with visits at the DCRP every 10 days. If the subject is eligible, they will be asked to return two weeks later fo...
Eligibility Criteria
Inclusion
- 18-65 years old
- Meet criteria for current Major Depressive Disorder
- Currently taking an SSRI
Exclusion
- Pregnant women
- Unstable medical illness including cardiovascular, hepatic, renal, respiratory, endocrine, neurological, or hematological disease
- Prior course of MTHF augmentation, or intolerance to MTHF at any dose
- Substance use disorders active within the last six months, any bipolar disorder (current or past), any psychotic disorder (current or past)
- Have failed more than 2 adequate antidepressant trials during the current Major Depressive Episode
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT00955955
Start Date
July 1 2009
End Date
April 1 2011
Last Update
April 28 2017
Active Locations (6)
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1
University of California San Diego School of Medicine
San Diego, California, United States, 92093
2
Rush University Medical Center, Psychiatric Medicine Associates, LLC
Chicago, Illinois, United States, 60612
3
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
4
University of Cincinnati, College of Medicine
Cincinnati, Ohio, United States, 45221