Correlation of Clinical Response With Homocysteine Reduction During Therapy With Reduced B Vitamins in Patients With MDD Who Are Positive for MTHFR C677T or A1298C Polymorphism
| Autor: | Andrew Farah, Arnold W. Mech |
|---|---|
| Rok vydání: | 2016 |
| Předmět: |
Adult
Male medicine.medical_specialty Adolescent Homocysteine Statistics as Topic Placebo-controlled study Placebo Gastroenterology law.invention Young Adult 03 medical and health sciences chemistry.chemical_compound 0302 clinical medicine Double-Blind Method Randomized controlled trial law Internal medicine Humans Medicine Micronutrients Psychiatry Methylenetetrahydrofolate Reductase (NADPH2) Psychiatric Status Rating Scales Depressive Disorder Major Polymorphism Genetic biology business.industry Middle Aged medicine.disease 030227 psychiatry Psychiatry and Mental health B vitamins chemistry Methylenetetrahydrofolate reductase Vitamin B Complex biology.protein Major depressive disorder Female medicine.symptom business Mania 030217 neurology & neurosurgery |
| Zdroj: | The Journal of Clinical Psychiatry. 77:668-671 |
| ISSN: | 0160-6689 |
| DOI: | 10.4088/jcp.15m10166 |
| Popis: | OBJECTIVE This study was designed to evaluate the efficacy and safety of reduced B vitamins as monotherapy in adults with major depressive disorder (MDD) who were also positive for at least 1 methylenetetrahydrofolate reductase (MTHFR) polymorphism associated with depression and further test the hypothesis that reduced (metabolized) B vitamins will lower homocysteine in a majority of clinically responding patients. METHODS 330 adult patients with MDD (DSM-5) and positive for either MTHFR C677T or A1298C polymorphism were enrolled in a trial conducted between August 1, 2014, and April 3, 2015. 160 patients received placebo, while 170 received a capsule containing a combination of reduced B vitamins. Plasma homocysteine levels were measured at baseline and week 8. The Montgomery-Asberg Depression Rating Scale (MADRS) was used to evaluate efficacy for MDD. RESULTS 159 of 170 vitamin-treated patients and 123 of 160 placebo-treated patients were completers. Of the active treatment group, 131 (82.4%) showed a reduction in homocysteine (for a mean in this subgroup of 25%, P < .001), while 28 (17.6%) showed no significant change. Placebo patients demonstrated a small elevation in homocysteine. Active-treatment patients demonstrated, on average, a 12-point reduction on the MADRS by week 8, and 42% achieved full remission (P < .001). No side effect was significantly different between groups. No patients experienced mania. CONCLUSIONS A combination of reduced B vitamins and micronutrients, when used in the treatment of MDD in patients with MTHFR polymorphism, resulted in a separation from placebo by week 2, and 42% of the treatment arm achieved remission by week 8. Further, clinical improvement correlated with a significant reduction in homocysteine levels in a majority of responders. These results support the homocysteine theory of depression and the safety and therapeutic benefit of reduced B vitamins as monotherapy for MDD, particularly in patients with MTHFR polymorphism. TRIAL REGISTRATION ClinicalTrials.gov identifier: NCT02709668. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|