This study will investigate the safety, tolerability, PK and PD profile of AUT00206 after repeated doses in patients with stable but symptomatic schizophrenia, taking one or two established anti-psychotic drugs. The subjects will undergo brain imaging, tests of cognition and tests of auditory function and electrophysiological measures in addition to routine safety monitoring. Because of the pioneering and novel mechanism of action of this drug, a key objective is to characterize this range of biomarkers which will inform the future development of the drug.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
24
4 capsules of 200mg AUT00206, twice daily, to take orally with food for 4 weeks
4 capsules of placebo, twice daily, to take orally with food for 4 weeks
King's College London Institute of Psychiatry, Psychology and Neuroscience (IoPPN)
London, United Kingdom
Number of Participants With Treatment-Related Adverse Events over 28 days treatment of AUT00206 compared to Placebo
Time frame: 28 days
Plasma concentrations of AUT00206
Time frame: 28 days
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