Zotepine loading in acute and severely manic patients: a pilot study.
OBJECTIVE
In clinical practice patients with severe mania (agitation, insomnia and aggressive behaviour) still receive effective, but often not well tolerated typical antipsychotics. The aim of this study was to test the first-generation atypical antipsychotic zotepine regarding its antimanic efficacy, tolerability and to find an adequate dosage for a loading strategy.


METHODS
Twelve patients (seven male) with an acute and severe manic episode, according to DSM-IV, received zotepine loading in individual dosages (up to 600 mg/day) over a maximum period of 3 weeks. Clinical efficacy was measured using the Young-Mania Rating Scale (Y-MRS) total score. Response was defined as a 50% reduction in the Y-MRS score. Safety was assessed by systematic collection of data on side effects and weight; Hamilton Rating Scale for Depression (HAM-D) scores were used to detect a switch into depression.


RESULTS
Two patients dropped out of the study after 2 days. Nine of ten patients (baseline mean Y-MRS: 45 +/- 7) were classified as responders, with five of them responding within 4 days. One patient did not respond sufficiently. No switch into a depressive episode occurred.


CONCLUSIONS
This open pilot study suggests that zotepine with a median daily dosage of 250 mg/day is effective with a rapid therapeutic effect in severely manic patients. In general, patients tolerated the drug well; dose-dependent extrapyramidal side effects, an increase in weight and autonomic side effects occurred to a lesser degree. This is the first study assessing zotepine monotherapy in manic patients. Controlled studies are warranted.
Amann
Benedikt
B
Department of Psychiatry, University LMU Munich, Germany.
Sterr
Andrea
A
Mergl
Roland
R
Dittmann
Sandra
S
Seemüller
Florian
F
Dobmeier
Matthias
M
Orth
Michael
M
Schaefer
Martin
M
Grunze
Heinz
H
D000208:Acute Disease; D000328:Adult; D014150:Antipsychotic Agents / Q000627:therapeutic use*; D001714:Bipolar Disorder / Q000175:diagnosis / Q000188:drug therapy* / Q000523:psychology; D039721:Diagnostic and Statistical Manual of Mental Disorders; D003988:Dibenzothiepins / Q000627:therapeutic use*; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008297:Male; D010865:Pilot Projects; D012720:Severity of Illness Index
D014150:Antipsychotic Agents; D003988:Dibenzothiepins; C022172:zotepine