A pragmatic randomised double-blind trial of Antipsychotic Treatment of very LAte-onset Schizophrenia-like psychosis: The ATLAS Trial - The ATLAS Trial

King's College London0 个研究点目标入组 101 人开始时间: 2011年9月6日最近更新: 2019年6月30日

适应症

试验速览

暂无简介。

•(i) Diagnosis of very late-onset schizophrenia-like psychosis as defined by International Consensus Group criteria, including onset of delusions and/or hallucinations after the age of 60 years,
•(ii) BPRS score =30, or active psychotic symptoms of a nature and severity that would be consistent with a BPRS score of 30 or greater
•(iii) Capacity to give informed consent to inclusion in trial (in the view of the responsible physician).
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 100
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 100

•(i) Evidence of significant cognitive impairment and standardised MMSE score <25,
•(ii) Uncontrolled serious concomitant physical illness,
•(iii) Primary diagnosis of affective disorder,
•(iv) Prescribed amisulpride in previous 28 days. (Patients who have been treated with other antipsychotic agents in the previous 28 days but still satisfy the eligibility criteria, and stopping current antipsychotic is considered appropriate, can participate and this will be included as a stratification factor at randomisation);
•(v) Contraindication to amisulpride (e.g. phaeochromocytoma, prolactin dependent tumour or potential drug interactions: e.g. with levodopa - see most recent Summary of Product Characteristics http://emc.medicines.org.uk/);
•(vi) Participation in another Clinical Trial of an Investigational Medicinal Product (IMP) in the previous 28 days; or
•(vii) Conditions which would prevent participants from having a blood test (eg needle phobia), or may lead to distress during attempts to take blood (eg history of poor intravenous access) will exclude participants from taking part in the optional blood test, but will NOT affect their participation in the trial

发起方