title: Intramuscular olanzapine versus intramuscular haloperidol plus lorazepam for the treatment of acute schizophrenia with agitation: An open-label, randomized controlled trial.
abstract: OBJECTIVE
  To compare the efficacy and safety profile between intramuscular (IM) olanzapine and IM haloperidol plus IM lorazepam in acute schizophrenic patients with moderate to severe agitation.
  
  
  METHODS
  This was a prospective, randomized, open-label study. Acutely agitated patients with schizophrenia or schizoaffective disorder (n = 67) were randomized to receive 10 mg IM olanzapine (n = 37) or 5 mg IM haloperidol plus 2 mg IM lorazepam (n = 30). Agitation was measured with Positive and Negative Syndrome Scale Excited Component (PANSS-EC) and Agitation-Calmness Evaluation Scale (ACES) during the first 2 hours and at 24 hours after the first injection. Safety was assessed using the Simpson-Angus Scale and Barnes Akathisia Rating Scale and by recording adverse events at 24 hours following the first injection. The Clinical Global Impression-Severity scale was also rated.
  
  
  RESULTS
  The PANSS-EC scores decreased significantly at 2 hours after the first injection in both groups (olanzapine: -10.2, p < 0.001; haloperidol + lorazepam: -9.9, p < 0.001). Haloperidol plus lorazepam was not inferior to olanzapine in reducing agitation at 2 hours. There were no significant differences in PANSS-EC or ACES scores between the two groups within 2 hours following the first injection. The frequencies of adverse events and changes in Clinical Global Impression-Severity, Simpson-Angus Scale, and Barnes Akathisia Rating Scale scores from baseline to 24 hours showed no significant differences between the groups.
  
  
  CONCLUSIONS
  The findings suggest that IM haloperidol (5 mg) plus lorazepam (2 mg) is not inferior to IM olanzapine (10 mg) in the treatment of acute schizophrenic patients with moderate to severe agitation (ClinialTrials.gov identifier number NCT00797277).
authors: Department of Psychiatry, Chi-Mei Medical Center, Tainan, Taiwan; Department of Social Worker, Chia Nan University of Pharmacy and Science, Tainan, Taiwan.
authors: Charles Lung-Cheng
authors: CL
authors: Huang
authors: Department of Psychiatry, National Taiwan University Hospital and Collage of Medicine, National Taiwan University, Taipei, Taiwan. Electronic address: tjhwang@ntu.edu.tw.
authors: Tzung-Jeng
authors: TJ
authors: Hwang
authors: Department of Psychiatry, Chang Bing Show Chwan Memorial Hospital, Changhua County, Taiwan.
authors: Yi-Hsing
authors: YH
authors: Chen
authors: Institute of Statistics, National Chiao Tung University, Hsinchu, Taiwan.
authors: Guan-Hua
authors: GH
authors: Huang
authors: Department of Psychiatry, National Taiwan University Hospital and Collage of Medicine, National Taiwan University, Taipei, Taiwan.
authors: Ming H
authors: MH
authors: Hsieh
authors: Division of Biostatistics, Graduate Institute of Epidemiology and Preventive Medicine, College of Public Health, National Taiwan University, Taipei, Taiwan.
authors: Hsiu-Hsi
authors: HH
authors: Chen
authors: Department of Psychiatry, National Taiwan University Hospital and Collage of Medicine, National Taiwan University, Taipei, Taiwan.
authors: Hai-Gwo
authors: HG
authors: Hwu
mesh_terms: D000328:Adult; D014150:Antipsychotic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D001569:Benzodiazepines / Q000008:administration & dosage* / Q000009:adverse effects; D004359:Drug Therapy, Combination; D005260:Female; D006220:Haloperidol / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D007273:Injections, Intramuscular; D008140:Lorazepam / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D000077152:Olanzapine; D011446:Prospective Studies; D011569:Psychiatric Status Rating Scales; D011595:Psychomotor Agitation / Q000188:drug therapy*; D011618:Psychotic Disorders / Q000188:drug therapy*; D012559:Schizophrenia / Q000188:drug therapy*; D013624:Taiwan; D016896:Treatment Outcome
chemical_list: D014150:Antipsychotic Agents; D001569:Benzodiazepines; D006220:Haloperidol; D000077152:Olanzapine; D008140:Lorazepam
keywords: agitation; haloperidol; injection; lorazepam; olanzapine; schizophrenia