Phase 4
Completed N=75
Study of 6(S)-5-MTHF Among Selective Serotonin Reuptake Inhibitor-Resistant Outpatients With Major Depressive Disorder
Source: ClinicalTrials.gov NCT00955955 ↗Enrolled (actual)
75
Serious AEs
0.0%
Results posted
Jan 2013
Primary outcomePrimary: The 17-item Hamilton Depression Scale (HAM-D-17) — -7.4; -4.4; -3.8; -1.7 Scores on a scale — p=.05
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The 17-item Hamilton Depression Scale (HAM-D-17) |
-7.4; -4.4; -3.8; -1.7; -5.58; -3.04 | .05 |
| SECONDARY The Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR) |
-8.1; -5.7; -1.3; 0.5 | — |
Eligibility Criteria
Inclusion Criteria
- 18-65 years old
- Meet criteria for current Major Depressive Disorder
- Currently taking an SSRI
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
Data sourced from ClinicalTrials.gov (NCT00955955). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.