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. 2016 Nov 24;2016(11):CD004028. doi: 10.1002/14651858.CD004028.pub4

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