CLEAR - clozapine in early psychosis: study protocol for a multi-centre, randomised controlled trial of clozapine vs other antipsychotics for young people with treatment resistant schizophrenia in real world settings.

"Declarations Ethics approval and consent to participateThe trial will be conducted in compliance with the principles of the Declaration of Helsinki (1996), the principles of GCP and in accordance with all applicable regulatory requirements including but not limited to the Research Governance Framework and the Medicines for Human Use (Clinical Trial) Regulations 2004, as amended in 2006 and any subsequent amendments. The trial has been approved by London—Dulwich Research Ethics Committee (REC reference: 22/LO/0723) and obtained Clinical Trial Authorisation (CTA) from the Medicines & Healthcare products Regulatory Agency (MHRA; CTA 22926/0007/001–0003). Informed consent will be obtained, according to GCP guidelines. Consent for publicationNot applicable. Competing interestsThe authors declare no competing interests. Competing interests The authors declare no competing interests."

"Funding Funding to conduct the trial is provided by NIHR Health Technology Assessment Programme (NIHR131175). Funding for the mechanistic study is provided by the NIHR Efficacy and Mechanism Evaluation programme (NIHR150308). RE is funded by the National Institute for Health and Care Research (NIHR) Biomedical Research Centre at South London and Maudsley NHS Foundation Trust and King’s College London, and NIHR Research Professorship (NIHR300051). The views expressed are those of the authors and not necessarily those of the NIHR or the Department of Health and Social Care."

"Trial registration ISRCTN Number: 37176025, IRAS Number: 1004947."