CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 150 target
Drug / intervention
6(S)-5-MTHF (a Medical Food)other
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.

Search/NCT00321152
NCT00321152Phase 4Completed
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A Double-Blind, Placebo Controlled Study of 6(S)-5-MTHF Among SSRI-Resistant Outpatients With Major Depressive Disorder (MDD)

Massachusetts General Hospital·interventional·Posted May 3, 2006·Updated Jun 8, 2010

In Brief

A Phase 4 clinical trial evaluating 6(S)-5-MTHF (a Medical Food) for Major Depressive Disorder. Completed, enrolled 150 participants across 11 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--
ConditionsMajor Depressive Disorder
CountriesUnited States
CollaboratorsPamlab, L.L.C.

Timeline

Phase 4CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 3, 2006
Enrollment StartNov 1, 2006
Primary CompletionAug 1, 2008
Study CompletionJun 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 20.2 years ago

Interventions

6(S)-5-MTHF (a Medical Food)other

The study consists of 8 visits over a period of 8 weeks or 60 days. Eligible participants will be randomized to double-blind treatment with placebo or Deplin (6(S)-5-MTHF). Participants will have a greater than 50% chance of receiving active medication (Deplin) at some point in the 8 week study. At the end of the double-blind phase, both responders and non-responders who have completed the 8 week study will have the option of receiving free, open-label adjunctive treatment with either 7.5 mg or 15 mg of 6(S)-5-MTHF for 12 months. Subjects who agree to receive open-label treatment with 6(S)-5-MTHF for 12 months will be assessed every three (3) months until the end of the follow-up phase.