A phase IV, open-label, multi-center study to evaluate the efficacy, safety and tolerability of olanzapine in the treatment of schizophrenia or schizophreniform disorder among Filipino patients
The Philippine Journal of Psychiatry
;
: 28-35, 2003.
Article
in English
| WPRIM
| ID: wpr-632798
ABSTRACT
OBJECTIVE:
This open-label, multi-center, non-randomized study evaluated the efficacy, safety and tolerability of olanzapine in the treatment of schizophrenia or schizophreniform disorder among Filipino patients.METHOD:
Filipino outpatients with a DSM-IV diagnosis of either schizophrenia or schizophreniform disorder (N = 382) were enrolled in this study. They were treated with an initial dose of 10 mg/day of olanzapine with eventual titration to 5 to 20 mg/day as clinically indicated and were observed for 8 weeks. Efficacy was assessed with the Brief Psychiatric Rating Scale (BPRS) and Clinical Global Impression - Severity of Illness Scale (CGI-S). Safety was assessed by collecting adverse event reports and checking vital signs.RESULTS:
Statistically significant reductions from baseline to endpoint in both the mean BPRS Total score (from 36.77 +/- 12.12 to 11.43 +/10.39, p0.001) and mean CGI-S score (from 4.64 +/- 0.79 to 2.61 +/- 1.06, p0.001) were seen. The proportion of patients showing 20 percent improvement based on the BPRS Total score was 93.4 percent. Only 51 (13.7 percent) patients reported at least one treatment-emergent adverse event. The most commonly reported were somnolence (3.2 percent), weight loss (2.2 percent), tachycardia (1.3 percent), and headache (1.1 percent).CONCLUSION:
The study clearly demonstrates the efficacy, safety and tolerability of olanzapine in the treatment of schizophrenia and schizophreniform disorder among Filipino patients.
Full text:
Available
Index:
WPRIM (Western Pacific)
Main subject:
Brief Psychiatric Rating Scale
/
Outpatients
/
Psychotic Disorders
/
Schizophrenia
/
Tachycardia
/
Benzodiazepines
/
Weight Loss
/
Diagnostic and Statistical Manual of Mental Disorders
/
Headache
Type of study:
Controlled clinical trial
Limits:
Adolescent
/
Adult
/
Female
/
Humans
/
Male
Language:
English
Journal:
The Philippine Journal of Psychiatry
Year:
2003
Type:
Article
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