The British journal of psychiatry : the journal of mental science · 2003
Mood stabilisers plus risperidone or placebo in the treatment of acute mania. International, double-blind, randomised controlled trial.
Клиническое исследованиеСтатьяМногоцентровое исследованиеРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
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Yatham Laksami N, Grossman Fred, Augustyns Ilse, Vieta Eduard, Ravindran Arun
Аннотация
BACKGROUND: Few double-blind trials have examined the efficacy of a combination of a mood stabiliser and an atypical antipsychotic in acute mania.
AIMS: To determine the efficacy of risperidone in combination with a mood stabiliser in acute mania.
METHOD: Patients taking a mood stabiliser were randomised to 3 weeks' treatment with risperidone (n=75) or placebo (n=76).
RESULTS: Young Mania Rating Scale (YMRS) scores improved rapidly with significantly greater reductions at week 1 in the risperidone group compared with the placebo group. At end-point YMRS scores decreased by 14.5 and 10.3 points in the risperidone and placebo groups, respectively. Significant improvements v. placebo (P<0.05) were noted in the risperidone group on several other clinically meaningful measures. Additionally, a post hoc analysis excluding carbamazepine-treated patients (plasma concentrations of risperidone active moiety were 40% lower in this group) revealed significantly greater reductions (P=0.047) in YMRS scores in the risperidone group than in the placebo group. Incidence of adverse events was similar in both groups.
CONCLUSIONS: Risperidone is superior to placebo when used in combination with lithium or divalproex in acute mania.
AIMS: To determine the efficacy of risperidone in combination with a mood stabiliser in acute mania.
METHOD: Patients taking a mood stabiliser were randomised to 3 weeks' treatment with risperidone (n=75) or placebo (n=76).
RESULTS: Young Mania Rating Scale (YMRS) scores improved rapidly with significantly greater reductions at week 1 in the risperidone group compared with the placebo group. At end-point YMRS scores decreased by 14.5 and 10.3 points in the risperidone and placebo groups, respectively. Significant improvements v. placebo (P<0.05) were noted in the risperidone group on several other clinically meaningful measures. Additionally, a post hoc analysis excluding carbamazepine-treated patients (plasma concentrations of risperidone active moiety were 40% lower in this group) revealed significantly greater reductions (P=0.047) in YMRS scores in the risperidone group than in the placebo group. Incidence of adverse events was similar in both groups.
CONCLUSIONS: Risperidone is superior to placebo when used in combination with lithium or divalproex in acute mania.
Предметные рубрики MeSH
AdultAgedAntimanic AgentsAntipsychotic AgentsBasal Ganglia DiseasesBipolar DisorderBrief Psychiatric Rating ScaleDouble-Blind MethodDrug Administration ScheduleDrug Therapy, CombinationFemaleHumansLithium CompoundsLorazepamMaleMiddle AgedPsychiatric Status Rating ScalesRisperidoneTreatment OutcomeTreatment RefusalValproic Acid