Memantine Add-On Therapy to Clozapine - MAOTC

Mental Health Services North Holland North0 个研究点开始时间: 2013年1月29日最近更新: 2015年1月19日

试验速览

暂无简介。

•Eligible for the study are outpatients, both sexes, age 18 to 60, meeting DSM-IV criteria for schizophrenia, based on the definitions in the Mini International Neuropsychiatric Interview Plus (MINI-Plus) with persistent residual psychopathology, failing to achieve the remission criteria, after adequate treatment with clozapine for at least 6 months. Before the start of the study clozapine plasma concentration has been at least 350 ng/ml for 12 weeks or has not reached 350 ng/ml due to intolerability. Remission defined as simultaneous ratings of mild or less (= 3 points) on 8 of the PANSS items evaluating the core symptoms of schizophrenia (P1 delusions, G9 unusual thought content, P3 hallucinatory behaviour, P2 conceptual disorganisation, G5 mannerisms and posturing, N1 blunted affect, N4 passive or apathetic social withdrawal, N6 lack of spontaneity and flow of conversation) (Os van and Kahn, 2007). Patients should be able to understand the study information and procedures and give informed consent. All participants fulfilling the inclusion and not fulfilling the exclusion criteria may, after a detailed description by a doctor and the written declaration of informed consent on an according form, participate in the study.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 52
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•- Pregnancy.
•- Lactating women.
•- Female subjects without adequate contraception.
•- Known hypersensitivity to memantine or ingredients used in this tablet.
•- Uncontrolled epilepsy.
•- Recent myocardial infarction.
•- Uncontrolled hypertension.
•- Renal insufficiency (GFR < 30 ml/min).
•- Severe liver failure (ASAT 175 U/l and/or ALAT 225 U/l in men and 175 U/l in women).
•- Lactose intolerance.
•- Co-medication with NMDA-antagonists such as amantadine, ketamine, dextromethorphan.
•- Co-medication with glutamate antagonists such as lamotrigine and topiramate.
•- Extremely ill patients (Global Assessment of Functioning [GAF] = 20), who are not reliably able to give their informed consent.
•- Moderate or severe Alzheimer’s disease.

发起方

Mental Health Services North Holland North