Rituximab - Immunotherapy for Schizophrenia spectrum disorder in adults. An open pilot study.

Region Örebro län0 个研究点目标入组 12 人开始时间: 2018年12月18日最近更新: 2019年6月30日

适应症

试验速览

暂无简介。

•1) Age: 18 to 40 years
•2) Duration of psychiatric illness: exceeding 2 years
•3) Rated Markedly ill”, Severely ill” or ”Among the most extremely ill patients” on the Clinical Global Impression – Severity scale (CGI-S)
•4) Global Assessment of Functioning below 50
•5) Current diagnosis according to Diagnostic and Statistical Manual for Mental Disorders, 5th edition (DSM-5) of SSD (schizophrenia spectrum disorder)
•6) Treatment resistance, i.e. failing to remit despite adequate treatments
•7) If female and with any risk for pregnancy: willing to use contraceptives.
•8) If antipsychotic treatment is prescribed the plasma concentrations of the drug must be tested and shown to be within the therapeutic interval.
•9) Subjects should be judged by the investigator to be lucid and oriented to person, place, time, and situation when giving the informed consent.
•10) Immunoglobulin levels within the normal range
•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 12
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1) on-going immunomodulatory treatment
•2) pregnancy or breast-feeding
•3) weight below 40 kg
•4) clinically relevant on-going infection
•5) chronic infections
•6) positive screening test for hepatitis B, C, HIV, or tuberculosis
•7) any change of psychotropic medication within the previous 4 weeks
•8) much or very much improved already at baseline according to CGI-I, I i.e. scores of 1 or 2 by the clinician
•9) severe heart failure (NYHA grade IV) or other severe heart disease or history of cardiac arrhythmia or myocardial infarction
•10) unable to make an informed decision to consent to the trial
•11) in compulsory treatment
•12) treatment with clozapine within the last 2 months
•13) Previous treatments with immunosuppressive agents
•14) Malignancy currently or within 2 years prior to inclusion

发起方