Status:
COMPLETED
A Study of 6(S)-5-MTHF Among Serotonin Reuptake Inhibitor(SSRI)-Resistant Outpatients With Major Depressive Disorder (MDD)
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
Pamlab, L.L.C.
Conditions:
Major Depressive Disorder
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 inh...
Detailed Description
The study consists of two sequential phases, each lasting a total of four weeks (8 weeks total), with visits every 10 days. Once patients agree to participate in the study by signing the informed cons...
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), or 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 :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2010
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00321152
Start Date
November 1 2006
End Date
June 1 2010
Last Update
June 8 2010
Active Locations (11)
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1
University of California San Diego School of Medicine
San Diego, California, United States, 92161
2
Rush University Medical Center, Psychiatric Medicine Associates, LLC
Chicago, Illinois, United States, 60612
3
Lousiana State University Health Sciences Center
New Orleans, Louisiana, United States, 70115
4
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114