Abstract
Rationale and objective
Depression symptoms are now recognized to be the predominant cause of disability for bipolar disorder (BD) patients. The treatment strategies for the depressed phase of BD remain more anecdotal than data-based. Olanzapine has been investigated as an alternative to antidepressants and a mood stabilizer for acute bipolar depression. The purpose of this study was to assess the efficacy of olanzapine monotherapy for bipolar I depression.
Method
Sixty-eight patients with bipolar I depression were randomly assigned to treatment with olanzapine (mean final dose 14.4 mg/day) (n = 34) or placebo (n = 34) in a double-blind parallel-group study design. Planned assessments included Montgomery-Asberg Depression Rating Scale (MADRS), Young Mania Rating Scale (YMRS), Clinical Global Impressions-Severity of Illness scale (CGI-S), Clinical Global Impressions-Improvement scale (CGI-I), Hamilton Depression scale (HAMD), Hamilton Anxiety scale (HAMA), and Treatment Emergent Symptom Scale (TESS).
Results
Of the 68 patients who were randomly assigned, 57 (83.8 %) completed treatments. Improvements in MADRS total score, CGI-S, CGI-I, and HAMD in the olanzapine group were significantly greater relative to those in the placebo group during the 8-week follow-up period (p < 0.001, p = 0.0017, p = 0.007, and p < 0.001, respectively). Rates of categorical treatment response and remission in the olanzapine group (50.0 % and 35.3 %, respectively) were significantly higher than those in the placebo group (20.6 %, p = 0.011 and 11.8 %, p = 0.022, respectively). At the 8-week treatment, the mean weight and the total cholesterol, triglyceride, and low-density lipoprotein cholesterol levels increased significantly in the olanzapine group (p = 0.037, p = 0.029, p = 0.030, and p = 0.028, respectively).
Conclusions
Olanzapine is effective in the treatment of bipolar I depression but is associated with significant metabolic side effects.
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Acknowledgments
This article was supported by research grants from the Scientific Research Fund of Liaoning Science and Technology Agency, China (No. 2011225020) and the Scientific Research Fund of First Hospital of CMU (No. FSFH1301).
The authors are entirely responsible for the scientific content of the paper.
The experiments comply with the current laws of China.
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Trial registry name: Efficacy of olanzapine monotherapy for treatment bipolar I depression: a randomized, double-blind, placebo controlled study
Registration identification number: NCT01303601
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Wang, M., Tong, Jh., Huang, Ds. et al. Efficacy of olanzapine monotherapy for treatment of bipolar I depression: a randomized, double-blind, placebo controlled study. Psychopharmacology 231, 2811–2818 (2014). https://doi.org/10.1007/s00213-014-3453-1
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DOI: https://doi.org/10.1007/s00213-014-3453-1