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

Phase 4

Completed

Brief 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).

Detailed Description: The study consists of two phases, each lasting a total of four weeks (8 weeks total), with visits at the DCRP every 10 days. If the subject is eligible, they will be asked to return two weeks later for a baseline visit, when they will be randomly assigned, like a flip of a coin, to one of three treatment groups: a) drug/drug, b) placebo/drug, c) placebo/placebo (a placebo is a pill that looks like a study drug but contains no active medication). They will have a greater than 50% chance of receiving active medication (Deplin) at some point in the 8 week study.

Neither the subject nor the research staff will know which group the subject is in.

All subjects will be asked to take the study medication in the morning, in addition to their ongoing SSRI treatment.

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

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

Primary Outcome Measures

Name	Time	Method
The 17-item Hamilton Depression Scale (HAM-D-17)	Baseline and Day 60	The HAM-D-17 is a multiple choice questionnaire that clinicians may use to rate the severity of a patient's major depression. Items are scored on a scale of zero to four and higher scores indicate greater impairment. This scale is scored by summing the scores on each item and scores can range from 0-68. When assessing changes in HAMD score, negative changes indicate improvement (i.e. the score has decreased) and positive scores indicate a worsening of symptoms (i.e. scores have increased).

Secondary Outcome Measures

Name	Time	Method
The Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR)	Baseline and Day 60	This measure is a 16 item self report questionnaire assessing symptoms of depression. For each item, scores range from 0 to 3 with higher scores indicating greater impairment. To score this measure: 1. Enter the highest score from questions 1-4 (sleep items): ______ 2. Enter score on item 5 ____ 3. Enter the highest score from questions 6-9 (appetite/weight): ______ 4. Enter score on item 10 ____ 5. Enter score on item 11 ____ 6. Enter score on item 12 ____ 7. Enter score on item 13 ____ 8. Enter score on item 14 ____ 9. Enter the highest score from questions 15-16 (psychomotor items): ______ Total score range 0-27: ______ When assessing changes in this measure over time, negative means indicate an improvement (i.e. the scores decreased over time) and positive means indicate worsening in functioning.

Locations (6): University of California San Diego School of Medicine
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San Diego, California, United States
Rush University Medical Center, Psychiatric Medicine Associates, LLC
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Chicago, Illinois, United States
Massachusetts General Hospital
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Boston, Massachusetts, United States
University of Cincinnati, College of Medicine
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Cincinnati, Ohio, United States
University of Pennsylvania
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Philadelphia, Pennsylvania, United States
Vanderbilt University Medical Center
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Nashville, Tennessee, United States
University of California San Diego School of Medicine
🇺🇸San Diego, California, United States