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