A study of AUT00206 in people with schizophrenia; v1
Research type
Research Study
Full title
A randomised, double-blind, placebo-controlled study of the safety, pharmacokinetics and exploratory pharmacodynamics of AUT00206 for 28 days as adjunctive therapy in patients with recently diagnosed schizophrenia (HMR code: 15-504)
IRAS ID
215896
Contact name
Frans van den Berg
Contact email
Sponsor organisation
Autifony Therapeutics Limited
Eudract number
2016-002704-63
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
The study medicine is an experimental treatment for schizophrenia: a condition that affects people’s thoughts, feelings and behaviour. We’re not sure what causes schizophrenia, but it’s been linked to a chemical imbalance in the brain. We hope the study medicine can be used with existing medicines (called antipsychotics) to correct that imbalance, and improve the symptoms of schizophrenia. \n\nWe’re doing this study in people with schizophrenia to assess whether the study medicine has any important side effects when given with patients’ regular antipsychotic(s). We’ll test blood levels of the study medicine, and assess whether it affects memory, or how patients think or feel. We’ll also test whether the study medicine affects the brain’s electrical activity – using ‘EEG’ – and might test whether it affects participants’ hearing.\n\nWe’ll give up to 24 men with schizophrenia, aged 18–50, twice-daily doses of the study medicine by mouth for 28 days (single dose on first and last day).\n\nParticipants will take up to 10 weeks to finish the study. They’ll have 2 screening visits, stay on the ward for 8 days and 7 nights, and have 4 outpatient visits.\n \nIn an additional part of the study, we’ll ask participants to have brain scans (called ‘fMRI’ and ‘PET’ scans). The scans will identify whether the study medicine affects certain chemicals in the brain or participants’ brain function. As part of the PET scan, participants will be exposed to radiation similar to 3 years’ background radiation. The scans will be done at 2 or more additional visits; participants can still do the main study if they don’t agree to the scans.\n\nA pharmaceutical company, Autifony Therapeutics Limited, is funding the study.\n\nThe main study will take place at 1 centre in London; the additional brain scans will be done at a separate centre in London.
REC name
London - Central Research Ethics Committee
REC reference
17/LO/0066
Date of REC Opinion
30 Jan 2017
REC opinion
Favourable Opinion