Trial reportBrain and behavior2021
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.
Trial report in Brain and behavior, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
8 citing papers in PubMed, 1 synthesis or guideline pooled it, 14 citations in OpenAlex.
- Nutraceuticals in Psychiatric Disorders: A Systematic Review.International journal of molecular sciences · 2024Pooled it
- Short-Term Effects of Folate Supplementation in Combination With Vitamin B6 for Treating Acute Manic Episodes in Bipolar I Disorder: A Randomized Controlled Trial.Brain and behavior · 2025Trial
- 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.Brain and behavior · 2021Trial
- Clinical outcomes of mitochondrial-enhancing nutraceutical supplementation in psychiatric disorders: A systematic review.General psychiatry · 2026Article
- Designing and characterizing first Iranian study evaluating serum levels of lithium in patients for population pharmacokinetics (FIRELOLIPOP): baseline and first report.Scientific reports · 2025Article
- Lithium, the gold standard drug for bipolar disorder: analysis of current clinical studies.Naunyn-Schmiedeberg's archives of pharmacology · 2024Review
- Utilizing systematic Mendelian randomization to identify potential therapeutic targets for mania.Frontiers in psychiatry · 2024Article
- Social Capital of Parents of Children and Adolescents and Its Relation to Psychiatric Disorders; A Population-Based Study.Community mental health journal · 2022Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveVitamin B6 has been linked to a variety of probable roles, including anti-inflammatory, 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.
methodsThis 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.
resultsAccordingly, 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.
conclusionsAccording 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.
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Registered trials
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