Efficacy of olanzapine in acute bipolar mania: A double-blind, placebo-controlled study

Mauricio Tohen, Thomas G. Jacobs, Starr L. Grundy, Susan L. McElroy, Michael C. Banov, Philip G. Janicak, Todd Sanger, Richard Risser, Fan Zhang, Verna Toma, Judith Francis, Gary D. Tollefson, Alan Breier

Research output: Contribution to journalArticle

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Abstract

Background: We compared the efficacy and safety of olanzapine vs placebo for the treatment of acute bipolar mania. Methods: Four-week, randomized, double-blind, parallel study. A total of 115 patients with a DSM-IV diagnosis of bipolar disorder, manic or mixed, were randomized to olanzapine, 5 to 20 mg/d (n=55), or placebo (n=60). The primary efficacy measure was the Young-Mania Rating Scale (Y-MRS) total score. Response and euthymia were defined, a priori, as at least a 50% improvement from baseline to end point and as a score of no less than 12 at end point in the Y-MRS total score, respectively. Safety was assessed using adverse events, Extrapyramidal Symptom (EPS) rating scales, laboratory values, electrocardiograms, vital signs, and weight change. Results: Olanzapine-treated patients demonstrated a statistically significant greater mean (± SD) improvement in Y-MRS total score than placebo-treated patients (-14.8±12.5 and -8.1±12.7, respectively; P

Original languageEnglish (US)
Pages (from-to)841-849
Number of pages9
JournalArchives of General Psychiatry
Volume57
Issue number9
StatePublished - 2000

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olanzapine
Bipolar Disorder
Placebos
Safety
Vital Signs
Double-Blind Method
Diagnostic and Statistical Manual of Mental Disorders
Electrocardiography
Weights and Measures

ASJC Scopus subject areas

  • Psychiatry and Mental health

Cite this

Tohen, M., Jacobs, T. G., Grundy, S. L., McElroy, S. L., Banov, M. C., Janicak, P. G., ... Breier, A. (2000). Efficacy of olanzapine in acute bipolar mania: A double-blind, placebo-controlled study. Archives of General Psychiatry, 57(9), 841-849.

Efficacy of olanzapine in acute bipolar mania : A double-blind, placebo-controlled study. / Tohen, Mauricio; Jacobs, Thomas G.; Grundy, Starr L.; McElroy, Susan L.; Banov, Michael C.; Janicak, Philip G.; Sanger, Todd; Risser, Richard; Zhang, Fan; Toma, Verna; Francis, Judith; Tollefson, Gary D.; Breier, Alan.

In: Archives of General Psychiatry, Vol. 57, No. 9, 2000, p. 841-849.

Research output: Contribution to journalArticle

Tohen, M, Jacobs, TG, Grundy, SL, McElroy, SL, Banov, MC, Janicak, PG, Sanger, T, Risser, R, Zhang, F, Toma, V, Francis, J, Tollefson, GD & Breier, A 2000, 'Efficacy of olanzapine in acute bipolar mania: A double-blind, placebo-controlled study', Archives of General Psychiatry, vol. 57, no. 9, pp. 841-849.
Tohen M, Jacobs TG, Grundy SL, McElroy SL, Banov MC, Janicak PG et al. Efficacy of olanzapine in acute bipolar mania: A double-blind, placebo-controlled study. Archives of General Psychiatry. 2000;57(9):841-849.
Tohen, Mauricio ; Jacobs, Thomas G. ; Grundy, Starr L. ; McElroy, Susan L. ; Banov, Michael C. ; Janicak, Philip G. ; Sanger, Todd ; Risser, Richard ; Zhang, Fan ; Toma, Verna ; Francis, Judith ; Tollefson, Gary D. ; Breier, Alan. / Efficacy of olanzapine in acute bipolar mania : A double-blind, placebo-controlled study. In: Archives of General Psychiatry. 2000 ; Vol. 57, No. 9. pp. 841-849.
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