At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 75 enrolled
Drug / intervention
6(S)-5-MTHF(Deplin) +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
TRD - 2: A Double-Blind, Placebo Controlled Study of 6(S)-5-MTHF Among SSRI-Resistant Outpatients With Major Depressive Disorder (MDD)
In Brief
A Phase 4 clinical trial evaluating 6(S)-5-MTHF(Deplin) and Placebo for Depression. Completed, enrolled 75 participants across 6 sites.
Detailed 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 inhibitors (SSRIs).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDepression
CountriesUnited States
CollaboratorsPamlab, L.L.C.
Timeline
Phase 4CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartJul 2009
First PostedAug 2009
Primary CompletionApr 2011
TodayJul 2026
First PostedAug 10, 2009
Enrollment StartJul 1, 2009
Primary CompletionApr 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 16.9 years ago
Interventions
6(S)-5-MTHF(Deplin)other
Deplin is a medical food. Patients will take 15 mg/day of deplin.
Placeboother
Inactive substance