KCL-00001335 - CANTOP

Tender description

CANTOP-RCT is a non-commercial, UK multi-centre, pragmatic, parallel group, randomised, double-blind, placebo-controlled clinical trial of cannabidiol (CBD) as a treatment in early psychosis. The primary objective of this trial is to test whether treatment with CBD improves psychotic symptoms when added to Treatment as Usual (TAU) in Clinical High Risk (CHR) patients. Patients will be randomised in a 1:1 ratio to either TAU + Cannabidiol or TAU + Placebo. The sample size is 300 patients (n=150 per arm). Patient recruitment will take place over 3 years. The total duration from first patient visit, to last patient visit, is anticipated to be 42 months. The trial is co-sponsored by King's College London and South London & Maudsley NHS Foundation Trust and is funded by the National Institute for Health Research (NIHR) Efficacy and Mechanism Evaluation (EME) programme. Service providers are invited to tender for the manufacture of the investigational medicinal products (including procurement of GMP grade CBD), complete associated stability and QC validation/testing, QP release, and store and distribute the IMP to UK trial sites. In order to compliantly participate in the tender process, all bidders are expected to fulfill the scope and specification requirements.