A Study of 6(S)-5-MTHF Among Serotonin Reuptake Inhibitor(SSRI)-Resistant Outpatients With Major Depressive Disorder (MDD)
Major Depressive Disorder
About this trial
This is an interventional treatment trial for Major Depressive Disorder
Eligibility Criteria
Inclusion Criteria: 18-65 years old Meet criteria for current Major Depressive Disorder Currently taking an SSRI Exclusion Criteria: 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.
Sites / Locations
- University of California San Diego School of Medicine
- Rush University Medical Center, Psychiatric Medicine Associates, LLC
- Lousiana State University Health Sciences Center
- Massachusetts General Hospital
- Burlington Medical Associates
- Waltham Family Practice
- Charles River Medical Associates
- Univeristy of Cincinnati, College of Medicine
- University of Pennsylvania
- Southeast Health Consultants, LLC
- Vanderbilt University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Placebo Comparator
1
2
3
Deplin/Deplin = participants will receive 7.5 mg/day of Deplin (6(S)-5-MTHF)for the first 4 weeks, and then 15 mg/day of Deplin for the next 4 weeks.
placebo/Deplin = participants will receive placebo for the first 4 weeks, and then 7.5 mg/day of Deplin (6(S)-5-MTHF) for the next 4 weeks.
placebo/placebo = both tablets of study medication will be placebo during both phases of the study.