Krakowski 2006.
Methods | Allocation: random; block randomisation with no baseline stratification; parallel group. Blinding: double‐blind. Duration: 1 to 2 weeks' pre‐trial baseline screening; 12 weeks' trial ‐ 6 weeks' escalation and fixed dose, 6 weeks' variable dose. |
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Participants | Diagnosis: schizophrenia/schizoaffective disorder (DSM‐IV). N=110. Age: 18 to 60 years. History: psychiatric inpatient at 1 of 2 New York state hospitals, hospitalised within the last year. Inclusion: clearly confirmed episode of physical assault during this hospitalisation, some persistence of aggression i.e. evidence of other aggressive event (physical or verbal or against property). Exclusion: people hospitalised for over 1 year; history of non‐response or intolerance to interventions; people with medical conditions adversely affected by interventions; people who received a depot antipsychotic drug within 30 days before randomisation. |
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Interventions | 1. Haloperidol: first 6 weeks, target endpoint 20 mg/day, mean dose 19.6 mg/day; last 6 weeks, range 10 mg/day to 30 mg/day, mean dose 23.3 mg/day. N=36. 2. Olanzapine: first 6 weeks, target endpoint 20 mg/day, mean dose 19.8 mg/day; last 6 weeks, range 10 mg/day to 35 mg/day, mean dose 24.7 mg/day. N=37. 3. Clozapine: first 6 weeks, target endpoint 500 mg/day, mean dose 457.1 mg/day; last 6 weeks, range 200 mg/day to 800 mg/day, mean dose 565.5 mg/day. N=37. |
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Outcomes | Leaving study early. Unable to use ‐ Aggression: MOAS (skewed data), subgroup: MOAS (randomisation status unclear). Mental state: PANSS (skewed data). Adverse effects: ESRS and checklist (no data reported). |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "Block randomisation" ‐ no further details. |
Allocation concealment (selection bias) | Unclear risk | Not stated. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | "Double blind" but no description of how blinding was ensured. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Raters, blind to treatment group, performed all clinical assessments. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Study attrition clearly reported ‐ table presented and intention‐to‐treat analysis performed. |
Selective reporting (reporting bias) | High risk | Adverse effects data not fully reported; numerical data for additional medications not fully reported. |
Other bias | Unclear risk | Supplemental funding from pharmaceuticals for "encapsulation of the medications". |
N: number of participants.
Rating scale abbreviations: ESRS: Extrapyramidal Symptom Rating Scale; MOAS: Modified Overt Aggression Scale; PANSS: Positive and Negative Syndrome Scale.
Diagnostic standards abbreviations: DSM‐IV: Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition.