Olanzapine versus flupenthixol in the treatment of inpatients with schizophrenia: a randomized double-blind trial.
OBJECTIVE
The atypical antipsychotic olanzapine has extensively been compared with haloperidol, whereas studies vs. other (conventional) neuroleptics are scarce. This exploratory double-blind 4-week study was designed to compare the efficacy and the safety of olanzapine (OLA) and flupenthixol (FLU) which have recently been considered as a "partially atypical" antipsychotics.


METHODS
Twenty-eight inpatients with schizophrenia (DSM-IV) were randomly assigned for treatment with OLA (N = 15, 5-20 mg/d) or FLU (N = 13, 5-20 mg/d). The Brief Psychiatric Rating Scale (BPRS) and the Negative Symptoms Rating Scale (NSRS), plus the Patient Global Impression (PGI) and Clinical Global Impression (CGI) scales, were used to assess the efficacy of both compounds; safety was determined by using the Simpson Angus Scale (SAS) and the Abnormal Involuntary Movement Scale (AIMS) and by assessing treatment-emergent adverse events. Non-parametric statistics were applied.


RESULTS
BPRS and NSRS scores improved in both groups (exploratory tests; all p < or = 0.02). Similar results were observed for CGI-Severity, CGI- and PGI-Improvement. There were no significant group differences. Responder rates (at least 40 % decrease in BPRS total) were 9/13 OLA patients (69 %) and 9/12 FLU patients (75 %). EPS events were reported only in the FLU group (p < 0.01); FLU patients needed significantly more anticholinergic medication. Weight gain was higher in OLA patients (p < 0.01). Overall, fewer patients with adverse events were observed in the OLA group (p = 0.04). No significant changes were noted on SAS and AIMS scores.


CONCLUSIONS
Findings from this study suggest that overall and negative symptomatology improved in both treatment groups, while the safety and tolerability profiles differed for both substances.
Gattaz
W F
WF
Department and Institute of Psychiatry, Laboratory of Neuroscience (LIM 27), Faculty of Medicine, University of São Paulo, Rua Dr. Ovidio Pires de Campos s/n, PO Box 3671, 05403-010 São Paulo, Brazil. gattaz@usp.br
Diehl
A
A
Geuppert
M S
MS
Hubrich
P
P
Schmitt
A
A
Linde
I
I
Maras
A
A
Dittmann
R W
RW
D000328:Adult; D014150:Antipsychotic Agents / Q000627:therapeutic use*; D001569:Benzodiazepines / Q000627:therapeutic use*; D010054:Brief Psychiatric Rating Scale; D016022:Case-Control Studies; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D005475:Flupenthixol / Q000627:therapeutic use*; D006801:Humans; D007297:Inpatients; D008297:Male; D000077152:Olanzapine; D012559:Schizophrenia / Q000188:drug therapy*; D016896:Treatment Outcome
D014150:Antipsychotic Agents; D001569:Benzodiazepines; D005475:Flupenthixol; D000077152:Olanzapine