title: A single-blind, comparative study of zotepine versus haloperidol in combination with a mood stabilizer for patients with moderate-to-severe mania.
abstract: OBJECTIVE
  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.
  
  
  CONCLUSIONS
  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.affiliation: General Psychiatry, Taoyuan Mental Hospital, Taoyuan, Taiwan.
authors.forename: Hung-Yu
authors.initials: HY
authors.lastname: Chan
authors.forename: Shaw-Hua
authors.initials: SH
authors.lastname: Jou
authors.forename: Yeong-Yuh
authors.initials: YY
authors.lastname: Juang
authors.forename: Ching-Jui
authors.initials: CJ
authors.lastname: Chang
authors.forename: Jiahn-Jyh
authors.initials: JJ
authors.lastname: Chen
authors.forename: Chiung-Hsu
authors.initials: CH
authors.lastname: Chen
authors.forename: Nan-Ying
authors.initials: NY
authors.lastname: Chiu
mesh_terms: D000328:Adult; D000368:Aged; D018692:Antimanic Agents / Q000627:therapeutic use; D014150:Antipsychotic Agents / Q000627:therapeutic use; D001714:Bipolar Disorder / Q000188:drug therapy*; D003988:Dibenzothiepins / Q000627:therapeutic use*; D004334:Drug Administration Schedule; D005260:Female; D006220:Haloperidol / Q000627:therapeutic use*; D006801:Humans; D057194:Intention to Treat Analysis; D008297:Male; D008875:Middle Aged; D018579:Patient Selection; D012720:Severity of Illness Index; D016037:Single-Blind Method; D016896:Treatment Outcome
chemical_list: D018692:Antimanic Agents; D014150:Antipsychotic Agents; D003988:Dibenzothiepins; D006220:Haloperidol; C022172:zotepine