A single-blind, comparative study of zotepine versus haloperidol in combination with a mood stabilizer for patients with moderate-to-severe mania.

Abstract

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 + or - 12.1 vs -22.3 + or - 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.

• Authors: Hung-Yu Chan, Shaw-Hua Jou, Yeong-Yuh Juang, Ching-Jui Chang, Jiahn-Jyh Chen, Chiung-Hsu Chen, Nan-Ying Chiu
• Journal: Psychiatry and clinical neurosciences (Psychiatry Clin Neurosci) Vol. 64 Issue 2 Pg. 162-9 (Apr 2010) ISSN: 1440-1819 [Electronic] Australia
• PMID: 20447012 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial)

Chemical References

• Antimanic Agents
• Antipsychotic Agents
• Dibenzothiepins
• Haloperidol
• zotepine

Topics

• Adult
• Aged
• Antimanic Agents (therapeutic use)
• Antipsychotic Agents (therapeutic use)
• Bipolar Disorder (drug therapy)
• Dibenzothiepins (therapeutic use)
• Drug Administration Schedule
• Female
• Haloperidol (therapeutic use)
• Humans
• Intention to Treat Analysis
• Male
• Middle Aged
• Patient Selection
• Severity of Illness Index
• Single-Blind Method
• Treatment Outcome