2. Suggested future trial.
Methods | Allocation: random Blinding: blind participants, treating team and raters. Duration: minimum one‐year follow‐up |
Participants | Diagnosis: people with schizophrenia and aggression, on those with treatment‐resistant forms of the disorder and on those with schizoaffective disorders (alternatively, several trials are necessary) Age: Sex: male and female. n = 300 |
Interventions | 1. Valproate in combination with any antipsychotic treatment: any dose 2. Placebo (or no intervention) in combination with any antipsychotic treatment |
Outcome | Leaving the study early (due to any reason, inefficacy‐ and tolerability‐related adverse events)
Service utilisation
Global state ‐ clinically important change*
Relapse
Mental state ‐ clinically important change (general and specific)
Behaviour ‐ clinically important change
Aggression ‐ clinically important change
Social functioning ‐ clinically important change Adverse effects ‐ clinically important general adverse effects*; sudden and unexpected death Economic outcomes Satisfaction with treatment Quality of life Pharmacokinetic interactions All outcomes by time ‐ short term (up to 12 weeks), medium term (13‐26 weeks) and long term (over 26 weeks) |
Notes | *Primary outcomes of interest |