Long-Term Olanzapine Therapy in the Treatment of Bipolar I Disorder: An Open-Label Continuation Phase Study
J Clin Psychiatry 2001;62(4):273-281
© Copyright 2016 Physicians Postgraduate Press, Inc.
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Background: Olanzapine has demonstrated efficacy
in the treatment of acute mania in 2 double-blind,
placebo-controlled trials. We describe the results of the
open-label extension from one of these trials.
Method: In a 3-week, double-blind study of
patients with DSM-IV bipolar I disorder, olanzapine was superior
to placebo for the treatment of acute manic symptoms. Of the 139
patients who entered the double-blind phase of the 3-week study,
113 patients continued into the 49-week open-label extension.
Efficacy measurements including the Young Mania Rating Scale
(YMRS), the 21-item Hamilton Rating Scale for Depression
(HAM-D-21), the Clinical Global Impressions scale-Bipolar
Version, and the Positive and Negative Syndrome Scale and safety
measurements including the Simpson-Angus scale, the Barnes
Akathisia Scale, and the Abnormal Involuntary Movement Scale were
completed throughout. The analysis considered all treatment
results, starting with the first olanzapine dose. Adjunctive
lithium and fluoxetine were allowed during the open-label
Results: The mean length of olanzapine
treatment was 6.6 months, with a mean modal dose of 13.9 mg/day.
A significant mean improvement in the YMRS total score, baseline
to endpoint (-18.01, p < .001), was observed. During
treatment, 88.3% of patients experienced a remission of
manic symptoms (YMRS total score <= 12), and only 25.5%
subsequently relapsed (YMRS total score >= 15). Significant
improvement in HAM-D-21 scores was observed (p < .001).
Forty-one percent of patients were maintained on olanzapine
monotherapy. The most common treatment-emergent adverse events
reported were somnolence (46.0%), depression (38.9%), and weight
Conclusion: During up to 1 year of olanzapine
therapy, either as monotherapy or in combination with lithium
and/or fluoxetine, patients with bipolar disorder demonstrated
significant improvement in mania and depression symptoms with a
favorable safety profile. Further double-blind, controlled
studies are needed to confirm these results.