Vitamin B6 and B12 in the Treatment of Movement Disorders Induced by Antipsychotics

What Was Tested

The trial (phase 2, phase 3) is built around Cyanocobalamin (Vitamin B12).

D2 dopaminergic receptor blockers, used to treat schizophrenia, can lead to the onset of movement disorders.

Drug-induced movement disorders encompass several syndromes.

Parkinsonism, dystonia, dyskinesia and akathisia are the most prevalent.

It had three arms (groups): Experimental group 1 (experimental), Experimental group 2 (experimental) and Placebo oral tablet (sham comparator).

15 subjects will be randomly assigned to adjuvant treatment with placebo.

The registry classes the interventions as drug.

More on the Plan

D2 dopaminergic receptor blockers, used to treat schizophrenia, can lead to the onset of drug-induced movement disorders, such as parkinsonism, dystonia, dyskinesia and akathisia.

The investigators will randomly assign 45 patients into three groups: placebo, B6 or B12 and check whether administration of vitamin B6 (pyridoxine) or B12 (cobalamin) attenuates drug-induced movement disorders (IDDM) in patients with diagnosis of schizophrenia, schizoaffective or bipolar disorder.

Specific Aim 2: To quantify changes in serum markers of inflammation and biomarkers of oxidative stress in response to adjunctive treatment with B6 or B12.

The hypothesis is that changes in these biomarkers will mediate the clinical response to them.

Who Took Part

Enrollment: 45 planned participants were the target.

It was open to people of any sex aged from 18 years up to 60 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Capacity to provide informed consent;. Schizophrenia diagnosis (confirmed by Structured Clinical Interview (SCID);. Movement disorders induced by psychotropic drugs of at least moderate severity;. Exposure to psychotropic medication for at least three months prior of the appearance of movement disorders;. Disorders of movement for at least one year;.

The full record lists 6 inclusion and 4 exclusion criteria; among the exclusions: 6-month history of any drug or alcohol abuse or dependence;; changes in psychotropic medications within the last 4 weeks;; women who are planning to become pregnant, are pregnant, or are breastfeeding.

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-blind.

Random assignment meant chance, not the researchers, decided who got Cyanocobalamin (Vitamin B12) and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Blinding on both sides kept the participants and researchers unaware of who received Cyanocobalamin (Vitamin B12).

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2019-09-03 with completion listed for 2020-06-03.

It ran at 1 site in Brazil.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change in the Simpson-Angus Extrapyramidal Symptoms Scale (SAS) scores (time frame: Baseline and 12 weeks). Change in the Barnes Akathisia Rating Scale (BAS, BARS) scores (time frame: Baseline and 12 weeks). Change in the Abnormal Involuntary Movement Scale (AIMS) scores (time frame: Baseline and 12 weeks).

It also tracked 9 secondary outcomes, for example Change in the Brief Psychiatry Rating Scale (BPRS) scores, Change in Plasma Glutathione (GSH), Change in serum level of Nitrite, Change in serum level of Thiobarbituric acid reactive substances (TBARS), Change in serum level of Interleukin 1 β (IL-1β) and Change in serum level of Interleukin-4.

What This Means in Plain Language

Put simply, this is a phase 2, phase 3, randomized trial of Cyanocobalamin (Vitamin B12) in 45 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Cyanocobalamin (Vitamin B12) compound page, all human trials.