NCT00866645 2009.
Methods | Allocation: randomised. Blindness: single. Duration: 72 hours. |
Participants | Diagnosis: DSM‐IV diagnosis of schizophrenia or schizophreniform psychosis. N = not stated. Age: range > 18 < 65 years. Sex: males and females. History: not stated. Exclusion: investigator and his/her relatives, participation in another drug trial within 3 months prior to enrolment into this study, pregnant or lactating women, serious medical illness, a significantly abnormal value in ECG or lab results, family history of sudden death, meet the DSM‐IV criteria for substance abuse within 1 year prior to enrolment, regular use of antipsychotics (clozapine within 90 days), antidepressants, mood stabilisers, anti‐epileptics or prolonged‐action preparations within 2 weeks prior to enrolment, use of ECT within 30 days prior to enrolment, systematic use of sulpiride, levosulpiride, or haloperidol therapy within 30 days prior enrolment, history of neuroleptic malignant syndrome, severe EPS or significant tardive dyskinesia, severe suicide attempt, know hypersensitivity to sulpiride, levosulpiride or haloperidol, history of hypersensitivity to more than 2 drugs, use of psychotropics (except for permitted drugs) within 12 hours prior to enrolment, known lack of efficacy to levosulpiride or haloperidol by formal treatment before, organic mental disorders including learning disability, history of psychosurgery treatment, people who could not comply with the study protocol. Setting: psychiatric inpatient ward, China. |
Interventions | 1. Haloperidol: dose 5 mg/IM, ≥ 4 hours apart, maximum 10 mg during 24 hours. 2. Levosulpiride: dose 50 mg/IM, ≥ 4 hours apart, maximum 100 mg during 24 hours. |
Outcomes | Mental state: BPRS, PANSS Total. Global State: CGI, CGI‐I, CGI‐S. Agitation: ACES, PANSS‐EC. Adverse effects: BAS, ECG, laboratory tests, physical examination, RSESE. |
Notes | Protocol, full characteristics and outcome data not reported. Attempted to contact author to enquire whether there is any available data. |