Article

Clozapine Augmented With Risperidone in the Treatment of Schizophrenia: A Randomized, Double-Blind, Placebo-Controlled Trial

Department of Psychiatry, Drexel University, Filadelfia, Pennsylvania, United States
American Journal of Psychiatry (Impact Factor: 13.56). 02/2005; 162(1):130-6. DOI: 10.1176/appi.ajp.162.1.130
Source: PubMed

ABSTRACT The authors evaluated the efficacy and safety of augmenting clozapine with risperidone in patients with treatment-resistant schizophrenia.
In a randomized, double-blind, placebo-controlled 12-week trial, 40 patients unresponsive or partially responsive to clozapine monotherapy received a steady dose of clozapine combined with either placebo (N=20) or up to 6 mg/day of risperidone (N=20). Patient psychopathology was assessed at 2-week intervals with the Brief Psychiatric Rating Scale (BPRS) and the Scale for the Assessment of Negative Symptoms (SANS), among other measures. Movement disorders were assessed with the Simpson-Angus Rating Scale.
From baseline to week 6 and week 12, mean BPRS total and positive symptom subscale scores were reduced significantly in both groups, but the reductions were significantly greater with clozapine/risperidone treatment. Reductions in SANS scores were also significantly greater with clozapine/risperidone treatment than with clozapine/placebo. The adverse event profile for clozapine/risperidone treatment was similar to that for clozapine/placebo. Simpson-Angus Rating Scale scores were lower with clozapine/risperidone treatment throughout the trial but increased to approach those of clozapine/placebo treatment at week 12. Clozapine/risperidone treatment did not induce additional weight gain, agranulocytosis, or seizures compared with clozapine/placebo treatment.
In patients with a suboptimal response to clozapine, the addition of risperidone improved overall symptoms and positive and negative symptoms of schizophrenia. The combination appears to be safe and well tolerated. Augmentation of clozapine with risperidone may provide additional clinical benefit for patients who are nonresponsive or only partially responsive to clozapine alone.

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    • "A vizsgálatok egymásnak ellentmondó eredményekre jutottak. Egyes randomizált kontrollált vizsgálatokban (Freudenreich et al., 2007; Josiassen et al., 2005) előnyösebbnek találták a clozapinhoz adott risperidon hatását a clozapin+placebónál, más vizsgálatokban azonban (Anil Yagcioglu et al., 2005; Honer et al., 2006) nem tudtak különbséget kimutatni ugyanezen két terápia között. A vizsgálatokból készült metaanalízisben (Correll et al., 2009) a clozapint tartalmazó kombinált kezelések a hatékonyság hiányának a vizsgálatokban használt definíciói alapján szignifikánsan hatékonyabbnak mutatkoztak, mint a clozapint nem tartalmazó kombinációk. "
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    • "Clozapine is the drug of choice in treatment-resistant schizophrenia , but 40–70% of clozapine-treated patients continue to demonstrate suboptimal clinical response [1] [2] [3] [4]. Various augmentation strategies have been tested, including the use of other atypical antipsychotics, but no clear recommendations can presently be proposed [5] [6] [7] [8] [9] [10]. "
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    • "Para proporcionar ejemplos publicados específicos, en un estudio a pequeña escala efectuado en pacientes con una respuesta parcial o sin respuesta al tratamiento con clozapina se demostró que la adición de sulpirida fue superior a placebo (Shiloh et al., 1997). Cuando se a ˜ nadió risperidona a la clozapina en un diseño similar también se demostró una diferencia modesta en el grupo clozapina más risperidona desde un punto de vista de los síntomas totales puntuados con la Brief Psychiatric Rating Scale (BPRS) (Josiassen et al., 2005). En una revista médica de gran impacto se publicó otro ensayo aleatorizado, controlado, que abordó la misma cuestión pero no demostró ningún efecto (Honer et al., 2006). "
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