A single-blind, comparative study of zotepine versus haloperidol in combination with a mood stabilizer for patients with moderate-to-severe mania.
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.
Chan
Hung-Yu
HY
General Psychiatry, Taoyuan Mental Hospital, Taoyuan, Taiwan.
Jou
Shaw-Hua
SH
Juang
Yeong-Yuh
YY
Chang
Ching-Jui
CJ
Chen
Jiahn-Jyh
JJ
Chen
Chiung-Hsu
CH
Chiu
Nan-Ying
NY
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
D018692:Antimanic Agents; D014150:Antipsychotic Agents; D003988:Dibenzothiepins; D006220:Haloperidol; C022172:zotepine