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

Completed · Phase 4 · Has a placebo group

Conditions studied: Depression

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

NCT00955955

Run by

George I. Papakostas

People needed

75

Starts

2009-07-01

Expected to finish

2011-04-01

Last updated by the study team

2017-04-28

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), 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
• Massachusetts General Hospital — Boston, Massachusetts, United States
• University of Cincinnati, College of Medicine — Cincinnati, Ohio, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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