Lorazepam 2006, USA.

Study characteristics
Methods	Allocation: randomised. Blinding: double blind. Design: prospective. Duration: 90 minutes. Setting: university affiliated emergency department, US.
Participants	Diagnosis: schizophrenia (n = 13), substance abuse (n = 8), bipolar (n = 4), personality disorder (n = 2), schizoaffective (n = 1), not stated (n = 2). n = 30. Age: mean 40 years. Gender: 23 men, 7 women. Ethnicity: not stated. Consent: informed consent required. History: not stated. Inclusion criteria: aged 18‐65 years, agitated or acutely psychotic (or both) people who required immediate treatment for symptom reduction. Exclusion criteria: medically unstable conditions, inability to provide informed consent, known allergy or adverse reaction to study drugs, pregnancy, administration of sedatives or antipsychotics in the emergency department prior to enrolment.
Interventions	Benzodiazepines + antipsychotics vs same benzodiazepines. 1. Lorazepam 2 mg IM + placebo oral (n = 10). 2. Lorazepam 2 mg IM + risperidone 2 mg oral (n = 10). 3. Lorazepam 2 mg IM + haloperidol 5 mg oral (n = 10).
Outcomes	Global impression: no improvement*; need for additional medication. Mental state: mean score (BPRS) (skew); mean score (PANSS) (skew). Leaving the study early.
Notes	*'Improvement' ‐ defined as number of participants who returned for the 24‐hour follow‐up visit and demonstrated a marked improvement on both BPRS and PANSS. 30% of participants tested positive on the urine screen for marijuana or cocaine; 33% of participants had positive blood alcohol levels. Pilot study. SDs calculated using the mean and confidence intervals.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	"Patients were randomly assigned to one of three double‐blind groups" ‐ no further description.
Allocation concealment (selection bias)	Unclear risk	Not stated.
Blinding (performance bias and detection bias) All outcomes	Unclear risk	Double blind ‐ no further description. Rating scales: administered by trained study evaluators, with inter‐rater reliability assessed by independent evaluation of a video‐taped mode
Incomplete outcome data (attrition bias) All outcomes	High risk	Follow‐up: 91%; 2 people withdrew after providing consent and before trial commenced and 1 participant was unable to stay awake after intervention, therefore, scores of interview not included in data analysis.
Selective reporting (reporting bias)	Low risk	All measure outcomes were reported.
Other bias	Unclear risk	Funding: study funded by a grant from Janssen Pharmaceutica. Unsure whether Janssen Pharmaceutica was involved in the study design and reporting.