A double-blind, randomized comparison of the efficacy and safety of intramuscular injections of olanzapine, lorazepam, or placebo in treating acutely agitated patients diagnosed With bipolar mania

Karena Meehan, Fan Zhang, Stacy David, Mauricio Tohen, Philip Janicak, Joyce Small, Kimberly Koch, Rosemary Rizk, Daniel Walker, Pierre Tran, Alan Breier

Research output: Contribution to journalArticle

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Abstract

There are no rapid-acting intramuscular formulations of atypical antipsychotics available for quickly calming an agitated patient with bipolar disorder. In this study, 201 agitated patients with bipolar mania were randomly assigned to receive one to three injections of the atypical antipsychotic olanzapine (10 mg, first two injections; 5 mg, third injection), the benzodiazepine lorazepam (2 mg, first two injections; 1 mg, third injection), or placebo (placebo, first two injections; olanzapine, 10 mg, third injection) within a 24-hour period. Agitation was measured at baseline, every 30 minutes for the first 2 hours, and at 24 hours after the first injection using the Positive and Negative Syndrome Scale-Excited Component subscale and two additional agitation scales. At 2 hours after the first injection, patients treated with olanzapine showed a significantly greater reduction in scores on all agitation scales compared with patients treated with either placebo or lorazepam. At 24 hours after the first injection, olanzapine remained statistically superior to placebo in reducing agitation in patients with acute mania, whereas patients treated with lorazepam were not significantly different from those treated with placebo or olanzapine. Furthermore, no significant differences among the three treatment groups were observed in safety measures, including treatment-emergent extrapyramidal symptoms, the incidence of acute dystonia, or QTc interval changes. These findings suggest that intramuscular olanzapine is a safe and effective treatment for reducing acute agitation in patients with bipolar mania.

Original languageEnglish (US)
Pages (from-to)389-397
Number of pages9
JournalJournal of Clinical Psychopharmacology
Volume21
Issue number4
DOIs
StatePublished - 2001

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olanzapine
Lorazepam
Intramuscular Injections
Bipolar Disorder
Placebos
Safety
Injections
Antipsychotic Agents
Dystonia

ASJC Scopus subject areas

  • Psychiatry and Mental health
  • Pharmacology (medical)
  • Pharmacology, Toxicology and Pharmaceutics(all)

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A double-blind, randomized comparison of the efficacy and safety of intramuscular injections of olanzapine, lorazepam, or placebo in treating acutely agitated patients diagnosed With bipolar mania. / Meehan, Karena; Zhang, Fan; David, Stacy; Tohen, Mauricio; Janicak, Philip; Small, Joyce; Koch, Kimberly; Rizk, Rosemary; Walker, Daniel; Tran, Pierre; Breier, Alan.

In: Journal of Clinical Psychopharmacology, Vol. 21, No. 4, 2001, p. 389-397.

Research output: Contribution to journalArticle

Meehan, Karena ; Zhang, Fan ; David, Stacy ; Tohen, Mauricio ; Janicak, Philip ; Small, Joyce ; Koch, Kimberly ; Rizk, Rosemary ; Walker, Daniel ; Tran, Pierre ; Breier, Alan. / A double-blind, randomized comparison of the efficacy and safety of intramuscular injections of olanzapine, lorazepam, or placebo in treating acutely agitated patients diagnosed With bipolar mania. In: Journal of Clinical Psychopharmacology. 2001 ; Vol. 21, No. 4. pp. 389-397.
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abstract = "There are no rapid-acting intramuscular formulations of atypical antipsychotics available for quickly calming an agitated patient with bipolar disorder. In this study, 201 agitated patients with bipolar mania were randomly assigned to receive one to three injections of the atypical antipsychotic olanzapine (10 mg, first two injections; 5 mg, third injection), the benzodiazepine lorazepam (2 mg, first two injections; 1 mg, third injection), or placebo (placebo, first two injections; olanzapine, 10 mg, third injection) within a 24-hour period. Agitation was measured at baseline, every 30 minutes for the first 2 hours, and at 24 hours after the first injection using the Positive and Negative Syndrome Scale-Excited Component subscale and two additional agitation scales. At 2 hours after the first injection, patients treated with olanzapine showed a significantly greater reduction in scores on all agitation scales compared with patients treated with either placebo or lorazepam. At 24 hours after the first injection, olanzapine remained statistically superior to placebo in reducing agitation in patients with acute mania, whereas patients treated with lorazepam were not significantly different from those treated with placebo or olanzapine. Furthermore, no significant differences among the three treatment groups were observed in safety measures, including treatment-emergent extrapyramidal symptoms, the incidence of acute dystonia, or QTc interval changes. These findings suggest that intramuscular olanzapine is a safe and effective treatment for reducing acute agitation in patients with bipolar mania.",
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