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. |
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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. |
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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. |
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Outcomes | Mental state: no improvement*. Mental state: mean score (total score of agitation items on BPRS, positive symptom score on BPRS). Adverse effects/events. |
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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. |