The efficacy of vitamin B6 as an adjunctive therapy to lithium in improving the symptoms of acute mania in patients with bipolar disorder, type 1; a double‐blind, randomized, placebo‐controlled, clinical trial

Abstract

Objective: Vitamin B6 has been linked to a variety of probable roles, including antiinflammatory, homocysteine-lowering, serotonin-regulating, and dopamine-lowering.In this study, we investigated the possible effect of vitamin B6 on bipolar disorder in manic episode with psychotic feature in a placebo-controlled double-blind clinical trial in a psychiatric hospital. Methods:This study was performed on 50 patients who were equally divided into two groups (each group included 25 patients) using 80 mg of vitamin B6 daily or placebo.At the beginning and end of the study, they were evaluated for lab tests, inflammatory biomarkers and level of blood homocysteine. Also, at the baseline and in weeks 2, 4, and 8, they were evaluated based on the anthropometric measurements, score obtained from the Young Mania Questionnaire, Mini-Mental State Examination (MMSE), and the Pittsburgh Sleep Questionnaire.Results: Accordingly, based on Yang Mania scoring scale, no significant difference was observed between the two groups receiving vitamin B6 and placebo (22.68 ± 5.39 vs. 21.80 ± 5.39 [p-value = .51]). Based on MMSE, significant improvement in cognitive status was obtained in group placebo compared to vitamin B6 group (25.24 ± 1.96 vs. 24.40 ± 3.25, respectively [p-value = .01]). At the Pittsburg scale (total, there was no statistically significant difference between the two groups receiving vitamin B6 and placebo (1.04 ± 0.20 vs. 0.48 ± 0.50 [p-value = .23]). Additionally, no significant difference was observed between the two groups regarding the anthropometric status.Conclusions: According to this study, the daily dose of 80 mg of vitamin B6 for 8 weeks in patients with bipolar disorder in the manic episode with psychotic feature treated daily with lithium, was not associated with a significant improvement in mood status compared to the control-placebo group. It is recommended to perform similar studies in a multi-center manner with a larger sample size and longer duration.

Utilizing systematic Mendelian randomization to identify potential therapeutic targets for mania

“…A cross-sectional study revealed that not only the content of vitamin B6 but also the content of minerals such as magnesium and zinc are significantly correlated with mania ( 33 ). Simultaneously, another RCT study on vitamin B6 ( 34 ) showed that after controlling for confounding factors, oral vitamin B6 could not improve the mental health of manic patients. Considering the different conclusions on vitamin B6, we will use the method of Mendelian randomization in the next step to analyse whether there is a causal relationship between vitamin B6 and mania.…”

Lithium, the gold standard drug for bipolar disorder: analysis of current clinical studies

“…However, due to a possible increase in lithium plasma concentrations when taking cyclooxygenase inhibitors, these should be closely monitored when taken currently. Neither adjuvant levetiracetam nor adjuvant vitamin B 6 to lithium significantly improved mania symptoms or sleep quality (Badrfam et al 2021;Keshavarzi et al 2022). Additional medication with agomelatine did not achieve a significant improvement in MADRS scores in depressed patients (Yatham et al 2016b).…”

Nutraceuticals in Psychiatric Disorders: A Systematic Review

“…Three studies on vitamin supplementation were conducted in the period examined [114,123,131]. As vitamin D supplementation seems to improve symptoms of unipolar depression, Marsh et al [114] administered 5000 IU/day of vitamin D for 12 weeks to patients suffering from BD and hypovitaminosis D, but did not find improvements in depressive, anxious, and manic symptoms measured with the Montgomery-Åsberg Depression Rating Scale (MADRS), the Hamilton Anxiety Rating Scale (HAM-A), and the Young Mania Rating Scale (YMRS).…”

“…Furthermore, as vitamin B6, in addition to having an anti-inflammatory effect and reducing homocysteine, plays a role in serotonin and dopamine regulation, two studies were conducted on this agent. In the first study, [123] vitamin B6 (80 mg) was administered daily in BD patients during a manic episode with psychotic manifestations in association with lithium. No significant differences in mood were observed in patients compared to controls.…”