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NCT00321152 · ClinicalTrials.gov registry record · Phase 4

A Study of 6(S)-5-MTHF Among Serotonin Reuptake Inhibitor(SSRI)-Resistant Outpatients With Major Depressive Disorder (MDD)

A Phase 4 study, sponsored by Massachusetts General Hospital.

Completed
Registry status
Phase 4
Development phase
150
Enrollment target

NCT00321152: Completed Phase 4 study, sponsored by Massachusetts General Hospital.

NCT00321152 is a Phase 4 study that has completed, run by Massachusetts General Hospital. The registered enrollment target is 150 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (71% lower). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

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The verdict

NCT00321152, a Phase 4 study, has completed, sponsored by Massachusetts General Hospital.

COMPLETED
Registry status
Phase 4
Development phase
150 participants
Enrollment target

Study 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).

Interventions

  • OTHER 6(S)-5-MTHF (a Medical Food)

Trial Details

FieldValue
Enrollment Target 150 participants
Start Date 2006-11
Est. Completion 2010-06
Phase Phase 4
Massachusetts General Hospital

2,032 total trials

What the finished NCT00321152 record still lists

NCT00321152 is an interventional study that assigns participants to a tested intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (71% lower).

The record links to 0 conditions, and to 1 intervention - of which 6(S)-5-MTHF (a Medical Food) is the first listed.

NCT00321152 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00321152 about?

NCT00321152 is a clinical study titled "A Study of 6(S)-5-MTHF Among Serotonin Reuptake Inhibitor(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).

What is the current status of trial NCT00321152?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 150 participants. The study started on 2006-11. Estimated completion is 2010-06.

What interventions are being tested in trial NCT00321152?

The interventions under investigation include: 6(S)-5-MTHF (a Medical Food) (OTHER).

Who is sponsoring clinical trial NCT00321152?

This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00321152's enrollment target sits among peer trials

150 533rd of 2000 higher than 1,436 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00321152, the US trial registry maintained by the National Library of Medicine. NCT00321152 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.