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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
75
Deplin is a medical food. Patients will take 15 mg/day of deplin.
Inactive substance
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
The 17-item Hamilton Depression Scale (HAM-D-17)
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).
Time frame: Baseline and Day 60
The Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR)
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.
Time frame: Baseline and Day 60
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University of Pennsylvania
Philadelphia, Pennsylvania, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States