Agitation is a broad term used to describe a cluster of symptoms that may range from mild to severe. It is a common feature of psychotic and bipolar disorders, and can be distressing both emotionally and physically. Patients with agitation are unable to relax and show signs of restlessness such as pacing, pressured speech or shouting. Severely agitated patients are at risk of causing harm to themselves and others. Although milder forms of agitation may be managed with psychological interventions, more severe agitation may need pharmacological treatment.

1. 1) to systematically review the evidence for the clinical effectiveness of pharmacological interventions used to management agitation associated with psychotic or bipolar disorders,

2. 2) to identify gaps in the research evidence base to inform decisions on research priorities.

Electronic databases including Medline, EMBASE, PsycInfo and The Cochrane Library were searched for relevant published literature of randomized controlled trials (RCTs). Predefined inclusion criteria were applied to citations in a two-stage process. Outcome measures included change in agitation levels as measured by accepted standard scales (e.g. PANSS-EC) clinical improvement as measured by The Clinical Global Impression rating scales and treatment emergent adverse effects.

In total, 17 RCTs with a total trial population of 4104 were included in the review. Of these, 11 compared one or more antipsychotics and 6 compared an antipsychotic with a benzodiazepine. Final results of the data synthesis will be reported.

The results of the review will summarise the current evidence base and identify future research needs.