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

Completed · Phase 4 · Has a placebo group

Conditions studied: Major Depressive Disorder

In brief

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).

Key facts

Study ID

NCT00321152

Run by

Massachusetts General Hospital

People needed

150

Starts

2006-11-01

Expected to finish

2010-06-01

Last updated by the study team

2010-06-08

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 18-65 years old
• Meet criteria for current Major Depressive Disorder
• Currently taking an SSRI

You may not qualify if…

• 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.

Where it is running

• University of California San Diego School of Medicine — San Diego, California, United States
• Rush University Medical Center, Psychiatric Medicine Associates, LLC — Chicago, Illinois, United States
• Lousiana State University Health Sciences Center — New Orleans, Louisiana, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Burlington Medical Associates — Burlington, Massachusetts, United States
• Waltham Family Practice — Waltham, Massachusetts, United States
• Charles River Medical Associates — Westborough, Massachusetts, United States
• Univeristy of Cincinnati, College of Medicine — Cincinnati, Ohio, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Southeast Health Consultants, LLC — Charleston, South Carolina, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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