Olanzapine Versus Risperidone in the Treatment of Manic or Mixed States in Bipolar I Disorder: A Randomized, Double-Blind Trial
J Clin Psychiatry 2006;67(11):1747-1753
© Copyright 2016 Physicians Postgraduate Press, Inc.
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Objective: To compare olanzapine and risperidone
in the treatment of nonpsychotic acute manic or mixed
Method: This 3-week, randomized,
controlled, double-blind, parallel multicenter study compared
olanzapine (5-20 mg/day; N = 165) and risperidone (1-6
mg/day; N = 164) among hospital inpatients who met
DSM-IV criteria for bipolar I disorder, manic or mixed
episode, without psychotic features. The study was
conducted at 30 sites in the United States between July
2001 and June 2002. The primary outcome measure was
the mean change in the Young Mania Rating Scale
(YMRS) total score. Secondary measures included the
21-item Hamilton Rating Scale for Depression (HAM-D-21),
the Montgomery-Asberg Depression Rating Scale (MADRS), the Clinical Global Impressions-Bipolar
Version (CGI-BP) severity of illness scale, and the
Cognitive Test for Delirium (CTD). Quality of life
(Short Form Health Survey [SF-12]), psychological
well-being (Psychological General Well-Being [PGWB]
inventory), and sexual functioning were also compared.
Results: Mean modal doses for olanzapine and
risperidone were 14.7 mg/day and 3.9 mg/day,
respectively. Between treatments, there was no difference
in mean change in the YMRS, MADRS, CTD, PGWB, or SF-12 measures or in remission or response rates.
Significantly more olanzapine-treated patients
completed the study compared with risperidone patients (78.7%
vs. 67.0%; p = .019). Olanzapine-treated patients
had greater HAM-D-21 (p = .040) and CGI-BP (p =
.026) score improvement across the study.
Olanzapine-treated patients experienced greater elevations in liver
function enzymes (p < .05) and increase in weight (2.5 kg vs.
1.6 kg; p = .004), while risperidone-treated patients
were more likely to experience prolactin elevation (51.73
ng/mL vs. 8.23 ng/mL; p < .001) and sexual
dysfunction (total score increase of 1.75 vs. 0.64; p = .049).
Conclusion: Both olanzapine and risperidone
treatment yielded similar improvements in mania. The
olanzapine group had significantly greater improvements
in secondary measures of severity and depressive
symptoms and better study completion rates but
experienced more weight gain.