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Intramuscular olanzapine versus intramuscular haloperidol plus lorazepam for the treatment of acute schizophrenia with agitation: An open-label, randomized controlled trial.
J Formos Med Assoc. 2015 May; 114(5):438-45.JF

Abstract

BACKGROUND/PURPOSE

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.

CONCLUSION

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+Show Affiliations

Department of Psychiatry, Chi-Mei Medical Center, Tainan, Taiwan; Department of Social Worker, Chia Nan University of Pharmacy and Science, Tainan, Taiwan.Department of Psychiatry, National Taiwan University Hospital and Collage of Medicine, National Taiwan University, Taipei, Taiwan. Electronic address: tjhwang@ntu.edu.tw.Department of Psychiatry, Chang Bing Show Chwan Memorial Hospital, Changhua County, Taiwan.Institute of Statistics, National Chiao Tung University, Hsinchu, Taiwan.Department of Psychiatry, National Taiwan University Hospital and Collage of Medicine, National Taiwan University, Taipei, Taiwan.Division of Biostatistics, Graduate Institute of Epidemiology and Preventive Medicine, College of Public Health, National Taiwan University, Taipei, Taiwan.Department of Psychiatry, National Taiwan University Hospital and Collage of Medicine, National Taiwan University, Taipei, Taiwan.

Pub Type(s)

Clinical Trial, Phase III
Comparative Study
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

25791540

Citation

Huang, Charles Lung-Cheng, et al. "Intramuscular Olanzapine Versus Intramuscular Haloperidol Plus Lorazepam for the Treatment of Acute Schizophrenia With Agitation: an Open-label, Randomized Controlled Trial." Journal of the Formosan Medical Association = Taiwan Yi Zhi, vol. 114, no. 5, 2015, pp. 438-45.
Huang CL, Hwang TJ, Chen YH, et al. Intramuscular olanzapine versus intramuscular haloperidol plus lorazepam for the treatment of acute schizophrenia with agitation: An open-label, randomized controlled trial. J Formos Med Assoc. 2015;114(5):438-45.
Huang, C. L., Hwang, T. J., Chen, Y. H., Huang, G. H., Hsieh, M. H., Chen, H. H., & Hwu, H. G. (2015). Intramuscular olanzapine versus intramuscular haloperidol plus lorazepam for the treatment of acute schizophrenia with agitation: An open-label, randomized controlled trial. Journal of the Formosan Medical Association = Taiwan Yi Zhi, 114(5), 438-45. https://doi.org/10.1016/j.jfma.2015.01.018
Huang CL, et al. Intramuscular Olanzapine Versus Intramuscular Haloperidol Plus Lorazepam for the Treatment of Acute Schizophrenia With Agitation: an Open-label, Randomized Controlled Trial. J Formos Med Assoc. 2015;114(5):438-45. PubMed PMID: 25791540.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Intramuscular olanzapine versus intramuscular haloperidol plus lorazepam for the treatment of acute schizophrenia with agitation: An open-label, randomized controlled trial. AU - Huang,Charles Lung-Cheng, AU - Hwang,Tzung-Jeng, AU - Chen,Yi-Hsing, AU - Huang,Guan-Hua, AU - Hsieh,Ming H, AU - Chen,Hsiu-Hsi, AU - Hwu,Hai-Gwo, Y1 - 2015/03/17/ PY - 2014/10/07/received PY - 2015/01/24/revised PY - 2015/01/29/accepted PY - 2015/3/21/entrez PY - 2015/3/21/pubmed PY - 2016/11/10/medline KW - agitation KW - haloperidol KW - injection KW - lorazepam KW - olanzapine KW - schizophrenia SP - 438 EP - 45 JF - Journal of the Formosan Medical Association = Taiwan yi zhi JO - J Formos Med Assoc VL - 114 IS - 5 N2 - BACKGROUND/PURPOSE: 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. CONCLUSION: 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). SN - 0929-6646 UR - https://www.unboundmedicine.com/medline/citation/25791540/Intramuscular_olanzapine_versus_intramuscular_haloperidol_plus_lorazepam_for_the_treatment_of_acute_schizophrenia_with_agitation:_An_open_label_randomized_controlled_trial_ DB - PRIME DP - Unbound Medicine ER -