Human psychopharmacology · 2007
An observational study of the effectiveness and safety of intramuscular olanzapine in the treatment of acute agitation in patients with bipolar mania or schizophrenia/schizoaffective disorder.
Клиническое исследованиеСтатьяМногоцентровое исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
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Centorrino Franca, Meyers Adam L, Ahl Jonna, Cincotta Stephanie L, Zun Leslie, Gulliver Angela H, Kinon Bruce J, Houston John P
Аннотация
OBJECTIVE: To determine the effect of intramuscular (IM) olanzapine in severely agitated patients.
METHODS: This was an open-label multicenter 1-week observational study of IM olanzapine treatment in severely agitated inpatients and psychiatric emergency services with bipolar mania (n = 22) or schizophrenia (n = 52). Mean change from baseline to 2 h post-first injection (LOCF) in agitation was assessed by PANSS-Excited Component (PANSS-EC) (score range: 5-35 points) mean change from baseline to 15, 30, 45, 60, 90, and 120 min post-first injection, and visit-wise mean changes from mixed-model repeated measures analysis of variance. Kaplan-Meier survival curve analyses estimated time to categorical response (rating of <or=3 points each PANSS-EC item).
RESULTS: Two hours post-injection of olanzapine (mean dose = 9.9 mg), patients exhibited mild calmness and agitation was significantly reduced by 19.2 +/- 1.0 points (p < 0.001) (mean baseline = 29.0). Over 90% of the patients received only one injection in the first 24 h and 50% had a categorical response within 30 min.
CONCLUSIONS: Severely agitated patients responded rapidly after a single injection of olanzapine with mild levels of sedation and without serious treatment-emergent adverse events.
METHODS: This was an open-label multicenter 1-week observational study of IM olanzapine treatment in severely agitated inpatients and psychiatric emergency services with bipolar mania (n = 22) or schizophrenia (n = 52). Mean change from baseline to 2 h post-first injection (LOCF) in agitation was assessed by PANSS-Excited Component (PANSS-EC) (score range: 5-35 points) mean change from baseline to 15, 30, 45, 60, 90, and 120 min post-first injection, and visit-wise mean changes from mixed-model repeated measures analysis of variance. Kaplan-Meier survival curve analyses estimated time to categorical response (rating of <or=3 points each PANSS-EC item).
RESULTS: Two hours post-injection of olanzapine (mean dose = 9.9 mg), patients exhibited mild calmness and agitation was significantly reduced by 19.2 +/- 1.0 points (p < 0.001) (mean baseline = 29.0). Over 90% of the patients received only one injection in the first 24 h and 50% had a categorical response within 30 min.
CONCLUSIONS: Severely agitated patients responded rapidly after a single injection of olanzapine with mild levels of sedation and without serious treatment-emergent adverse events.