FOCUS
Research type
Research Study
Full title
The efficacy of xanomeline-trospium in treating cognitive impairment in psychosis: An actively controlled double-blind randomised controlled trial
IRAS ID
1010141
Contact name
Robert McCutcheon
Contact email
Sponsor organisation
University of Oxford
ISRCTN Number
ISRCTN59554792
Research summary
The purpose of this study is to see if a new type of treatment for psychosis can help patients with problems in concentration and memory termed ‘cognitive symptoms’. All drugs currently used in the treatment of psychosis work by blocking dopamine receptors, termed ‘D2 antagonists’ in the brain. While these D2 antagonists help to improve the positive symptoms of the disorder (such as hallucinations and delusions), they are not effective when it comes to improving cognitive symptoms. A new drug, xanomeline-trospium (trade name Cobenfy), does not block dopamine receptors but instead binds to muscarinic receptors. Recent studies have shown that this compound may also be effective in treating psychosis.
FOCUS is a research study that compares the muscarinic drug xanomeline-trospium with a dopaminergic drug (a D2 antagonist) in treating cognitive symptoms in early psychosis. The study will include individuals with early psychosis who are considering a switch from their current medication (due either to side effects or a lack of effectiveness). Participants will be assigned to either receive xanomeline-trospium or a D2 antagonist (either lurasidone or risperidone) for 6 weeks.
FOCUS is a double-blinded study, which means that neither the research team nor the participant knows who is receiving xanomeline-trospium or the D2 antagonist. After 6 weeks, the participant will be informed about the received treatment condition and will be offered the option to continue with the received treatment for one year and to have a final visit after one year, during which the research team will remain blinded for the treatment condition.
The primary outcome will be the change between baseline and 6 weeks in performance on a battery of cognitive tests. Other measures like symptom rating scales and changes in brain imaging markers will also be assessed. Data from healthy individuals will be collected to help interpret the results.REC name
South West - Central Bristol Research Ethics Committee
REC reference
25/SW/0096
Date of REC Opinion
10 Nov 2025
REC opinion
Further Information Favourable Opinion