EFFECT OF SERTINDOLE TREATMENT ON THE COGNITIVE FUNCTION IN PATIENTS WITH CHRONIC SCHIZOPHRENIA

Tartu University Hospital0 个研究点开始时间: 2007年2月26日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•The study sample will include up to 60 patients with schizophrenia diagnosis according to DSM-IV criteria. Subjects will be recruited amongst the inpatients and outpatients of Psychiatry Clinic of Tartu University, Psychiatric Clinics of Tallinn, Viljandi and Pärnu.
•Inclusion criteria
•1.The patient is able to read and understand the patient information sheet
•2.Aged between 18 and 55 years inclusive
•3.Male or female patient,
•4. Women must be not pregnant and not lactating
•5.Schizophrenic patient according to DSM IV-TR diagnosis
•6.Patients having diagnosis for at least one year;
•7.No abnormal findings of clinical relevance in any of the investigations performed at the screening visit (physical exam, ECG).
•8.Patients with at least completed secondary educations
•9.Patients must have given written informed consent prior to screening assessments.
•10.The score >2 on at least two of the following five BPRS items: conceptual disorganisation (4), suspiciousness (11), hallucinatory behaviour (12), unusual thought content (15) and excitement (17). The sum of these items > 7.
•11.Significant cognitive impairment as objectively evaluated by neuropsychologists
•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
•F.1.3 Elderly (>=65 years)
•F.1.3.1 Number of subjects for this age range

•Exclusion criteria
•1.De novo patients;
•2.Significant cardiovascular or ECG abnormality, other contraindications according to national SPC of sertindole;
•3.Seizure disorders, severe cerebral trauma, stroke, Parkinson’s disease, dementia, or any other significant neurological illness;
•4.Serious risk of suicide evaluated according to the investigator.

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