Daniel 2004.
| Methods | Allocation: randomised, method not described. Blindness: double. Duration: 24hrs. Design: parallel, multicentre, dose‐ranging. Setting: inpatient. Consent: obtained. Loss: described. | |
| Participants | Diagnosis: schizophrenia, schizoaffective disorder, schizophreniform disorder (DSM IV). N=357. Age: >18 years. Sex: male 214, female 143. History: acute agitation; PEC score >15 and <32, and a score >4 on at least 2 items; deemed appropriate for intra‐muscular therapy. Exclusions: neurological or psychiatric condition other than schizophrenia, schizoaffective disorder or schizophreniform disorder; known non‐responders to anti‐psychotic medication; significant medical condition; psychoactive substance dependence within 2 months of study start; required involuntary restraint; suicidal. | |
| Interventions | 1. Aripiprazole IM: dose 1mg/day. N=57. 2. Aripiprazole IM: dose 5.25 mg/day. N=63. 3. Aripiprazole IM: dose 9.75 mg/day. N=57. 4. Aripiprazole IM: dose 15 mg/day. N=58. 5. Haloperidol IM: dose 7.5 mg/day. N=60. 6. Placebo IM. N=62. | |
| Outcomes | Global state: discontinuation from study due to lack of efficacy, marked deterioration, or adverse event including psychosis.
Mental state: response to treatment.
Adverse effects: reported in > 5% participants, extrapyramidal symptoms.
Death. Unable to use ‐ Global state: CGI score (inadequate data/unusable). Mental state: BPRS score (inadequate data/ unusable). Behaviour: PEC score (inadequate data/ unusable), CAB score‐ mean change (inadequate data/ unusable), ACES‐ (inadequate data/ unusable). Adverse effects: laboratory abnormalities (no usable data), mean changes in Simpson‐Angus scale (no usable data), Barnes Akathisia scale (no usable data). Satisfaction with treatment: leaving study early due to withdrawal of consent (no usable data). Economic outcomes: requiring additional dose of antipsychotic medication, benzodiazepines (incomplete data). Leaving study early (inadequate data/ unusable). |
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| Notes | Limited data reported on standard deviations. Data reported in LOCF analyses. Jadad=2. Only adverse effects occurring in over 5% participants recorded. Not all outcomes reported at 24hrs. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Allocation concealment (selection bias) | Unclear risk | B ‐ Unclear |