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. 2017 Dec 8;2017(12):CD003079. doi: 10.1002/14651858.CD003079.pub4

Clonazepam 2007a, CHN.

Study characteristics
Methods Allocation: randomised.
Blinding: double blinding, not state who was blinded.
Design: parallel.
Duration: 24 hours.
Setting: inpatients, Chinese hospital.
Participants Diagnosis: schizophrenia (CCMD‐III).
n = 45.
Age: 18‐45 years.
Gender: 20 men and 25 women.
Ethnicity: not stated.
Consent: yes.
History: not stated.
Inclusion criteria: schizophrenia (CCMD‐3), aged 18‐45 years, ≥ 4 on the agitation item from BPRS, ≥ 4 on any 1 of the following items from BPRS: unco‐operativeness, hostility, tension, mannerisms and posturing.
Exclusion criteria: serious physical illness, substance or alcohol dependence, received the study drugs 1 month prior to randomisation but with poor response.
Interventions Combined benzodiazepines/antipsychotics vs same antipsychotics + placebo vs same benzodiazepine + placebo.
1. Clonazepam 2‐6 mg IM + haloperidol 5‐15 mg IM (n = 15).
2. Haloperidol 5‐15 mg IM + placebo (n = 15).
3. Clonazepam 2‐6 mg IM + placebo (n =15).
Participants were administered scopolamine where EPS occurred.
Outcomes Mental state: no improvement*.
Mental state: mean score (total score of agitation items on BPRS, positive symptom score on BPRS).
Adverse effects/events.
Notes * decrease rate of BPRS score < 30%.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Randomised ‐ participants were "randomly allocated" based on random numbers.
Allocation concealment (selection bias) Unclear risk Not stated.
Blinding (performance bias and detection bias)
All outcomes Unclear risk Double blind, not state who was blinded.
Incomplete outcome data (attrition bias)
All outcomes Low risk Follow‐up: 100%.
Selective reporting (reporting bias) Low risk All measured outcomes were reported.
Other bias Low risk Funding: American John M Davis Funding. We did not detect any other potential bias.