Prospective cohort study evaluating prophylactic GCSF to prevent recurrent clozapine-associated neutropenia on clozapine re-challenge

niversity of Queensland0 个研究点目标入组 20 人开始时间: 2018年11月9日最近更新: 2019年11月11日

适应症

试验速览

暂无简介。

•1.Aged 18-64 years
•2.Clinical diagnosis of schizophrenia according to DSM-V criteria
•3.Treatment resistance defined as little or no symptomatic response to at least two antipsychotic trials of adequate duration (six weeks) and a previous trial of clozapine
•4.Previously diagnosis of clozapine-associated neutropenia defined as absolute neutrophil count of <1.5 whilst prescribed a therapeutic dose of clozapine (50-900mg daily)
•5.Considered by their treating psychiatrist to be likely to benefit from clozapine re-challenge or previously documented symptom response to clozapine which has not been maintained on alternative antipsychotic drugs
•6.Ability to understand study risks and benefits, and to provide informed consent

•1.Non-haematological contraindication to prescription of clozapine
•2.Currently prescribed clozapine
•3.Previous hypersensitivity reaction or allergy to G-CSF
•4.Active haematological malignancy, active solid organ malignancy requiring cytotoxic or myelosuppressive therapy or cytotoxic exposure within one year of study screening
•5.Existing or planned pregnancy or current breastfeeding
•6.Absolute neutrophil count <2.0 at study entry
•7.Homozygous sickle cell anaemia
•8.Pre-existing moderate or severe thrombocytopenia (platelet count <100x109/L)
•9.Pre-existing moderate or severe splenomegaly (craniocaudal diameter >150mm)
•10.Active glomerulonephritis, aortitis and/or pulmonary haemorrhage

发起方

niversity of Queensland