A single-blind, comparative study of zotepine versus haloperidol in combination with a mood stabilizer for patients with moderate-to-severe mania
Article first published online: 24 MAR 2010
© 2010 The Authors. Journal compilation © 2010 Japanese Society of Psychiatry and Neurology
Psychiatry and Clinical Neurosciences
Volume 64, Issue 2, pages 162–169, April 2010
How to Cite
Chan, H.-Y., Jou, S.-H., Juang, Y.-Y., Chang, C.-J., Chen, J.-J., Chen, C.-H. and Chiu, N.-Y. (2010), A single-blind, comparative study of zotepine versus haloperidol in combination with a mood stabilizer for patients with moderate-to-severe mania. Psychiatry and Clinical Neurosciences, 64: 162–169. doi: 10.1111/j.1440-1819.2010.02066.x
- Issue published online: 24 MAR 2010
- Article first published online: 24 MAR 2010
- Received 6 July 2009; revised 5 November 2009; accepted 24 December 2009.
- manic episode;
Aims: Atypical antipsychotics are increasingly used in the management of acute mania. This study was conducted to investigate the efficacy and tolerability of zotepine compared to haloperidol in combination with a mood stabilizer (lithium or valproate) for treatment of acute mania.
Methods: This was a multi-center, randomized, rater-blinded, parallel-group, flexible-dose study. Forty-five hospitalized patients with moderate-to-severe manic, bipolar disorder (DSM-IV) were randomly assigned to a zotepine or a haloperidol 4-week treatment group.
Results: There was no significant between-group difference in the Young Mania Rating Scale total scores between the zotepine and haloperidol groups (−23.7 ± 12.1 vs –22.3 ± 11.0, respectively). The adverse events in both groups were mild to moderate. The haloperidol group reported a higher incidence of treatment-related adverse events, especially parkinsonism and akathisia, compared to the zotepine group. Serum uric acid decreased more in the zotepine group than in the haloperidol group.
Conclusion: In combination with a mood stabilizer, zotepine appears to be as effective as haloperidol in treating moderate-to-severe mania in the acute phase, but has the advantages of lowering hyperuricemia and fewer extrapyramidal side-effects. Double-blinded studies with larger sample sizes are warranted to confirm these findings.