Depression Clinical Trial
Official title:
TRD - 2: A Double-Blind, Placebo Controlled Study of 6(S)-5-MTHF Among SSRI-Resistant Outpatients With Major Depressive Disorder (MDD)
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 inhibitors (SSRIs).
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 for a baseline visit, when they will be randomly assigned, like a flip of a
coin, to one of three treatment groups: a) drug/drug, b) placebo/drug, c) placebo/placebo (a
placebo is a pill that looks like a study drug but contains no active medication). They will
have a greater than 50% chance of receiving active medication (Deplin) at some point in the
8 week study.
Neither the subject nor the research staff will know which group the subject is in.
All subjects will be asked to take the study medication in the morning, in addition to their
ongoing SSRI treatment.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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