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. 2015 Apr 13;2015(4):CD010501. doi: 10.1002/14651858.CD010501.pub2

1. Possible design for a future study.

Method Allocation: randomised ‐ clearly described generation of sequence and concealment of allocation.
 Blinding: double ‐ described and tested.
 Duration: long term.
 Setting: Inpatients and outpatients
Design: Single phase, longer study duration.
Participants People with schizophrenia or schizophrenia‐like disorder.
 N = Sample size obtained through power calculation.
 Age: any
 Sex: both
History: History of tardive dyskinesia, fulfilling diagnostic criteria for tardive dyskinesia, stable on antipsychotic medication for at least 3 months.
Intervention 1.Pyridoxal Phosphate (vitamin B6), any dose
2. Placebo
Outcomes Tardive dyskinesia scores measured using AIMS (primary outcome)
Deterioration of tardive dyskinesia symptoms
Any other adverse effects
Discontinuation of pyridoxal phosphate (with reasons)
Psychiatric symptoms score using a standardised rating scale (PANSS, BPRS)
Pyridoxal phosphate dose
Plasma pyridoxal phosphate level
Quality of life
Satisfaction with care

AIMS: Abnormal Involuntary Movement Scale
 BPRS: Brief Psychiatric Rating Scale
 PANSS: Positve and Negative Scale of Schizophrenia