Comparison of the effects of Sertindole and Olanzapine on Cognition - SEROLA

nit for Psychiatric Research0 个研究点目标入组 100 人开始时间: 2009年8月3日最近更新: 2012年4月24日

适应症

试验速览

暂无简介。

•1.Both genders
•2.Between 18 and 65 years of age
•3.The ICD-10 schizophrenia diagnosis F20.0-F20.3 and F20.9 (paranoid, hebephrenic, catatonic, undifferentiated and unspecified)
•4.That all fertile women must use a safe form of birth control (birth control pills, spiral, gestagen depot injection, sub dermal implantation, hormonal vaginal ring and transdermal depot patch)
•5.A negative pregnancy test for women
•6.No known allergy to any of the substances in the study medication
•7.Baseline QTc < 450 milliseconds for men and < 470 milliseconds for women
•8.S-potassium and s-magnesium within normal reference range.
•9.Sub optimally treated on current antipsychotic medication
•10.Stable dosage of antidepressants and mood stabilizers one month before the inclusion
•11.Signed informed consent and power of attorney
•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) no
•F.1.3.1 Number of subjects for this age range

•1.Withdrawal of consent
•2.QTc prolongation >500 milliseconds
•3.Patients with known clinical important cardiovascular disease e.g., heart insufficiency, cardiac hypertrophy, arrhythmia or bradycardia (<50 beats per minute)
•4.Significant addictions interfering with outcome and compliance
•5.Earlier partial or non-response in treatment or intolerability to sertindole or olanzapine.
•6.Calgary Depression Scale score = 7
•7.Treatment that interferes with the metabolism of sertindole or olanzapine, e.g. potent inhibitors of CYP1A2, CYP3A4 and CYP2D6, e.g. ketoconazole, fluvoxamine and fluoxetine as described in the SPC of Serdolect
•8.Oxazepam, zopiclone or zolpidem treatment the last 48 hours before cognitive testing
•9.Prescription of not-allowed medication, or a change in dosage of antidepressant, or mood stabilizers in the study period
•10.Treatment with an anticholinergic after the first three weeks of the study
•11.Somatic illness, as judged by investigator, interfering with cognition, e.g. delirium
•12.Treatment with electroconvulsive therapy (ECT) the last three months before inclusion, or treatment with ECT in the study period
•13.Treatment with clozapine or depot antipsychotics before inclusion

发起方

nit for Psychiatric Research