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

Autifony Therapeutics (United Kingdom)0 sites24 target enrollmentFebruary 8, 2022

ConditionsSchizophrenia Mental and Behavioural Disorders

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Schizophrenia
Sponsor: Autifony Therapeutics (United Kingdom)
Enrollment: 24
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

2022 Results article in https://pubmed.ncbi.nlm.nih.gov/36164687/ (added 20/12/2022)

Registry

who.int

Start Date

February 8, 2022

End Date

April 3, 2019

Last Updated

3 years ago

Study Type

Interventional

Sex

Male

Investigators

Sponsor

Autifony Therapeutics (United Kingdom)

Eligibility Criteria

Inclusion Criteria

•1\. Aged 18–50 years
•2\. Schizophrenia diagnosis according to the Diagnostic and Statistical Manual of Mental Disorders\-5 (DSM\-5\); no more than 5 years (before screening) since first contact, diagnosis, and treatment with the psychiatric services for a psychotic illness. Subjects up to 5 years and 6 months post\-diagnosis may be included if considered otherwise suitable, at the discretion of the investigator.
•3\. One positive symptom \>3, or two or more positive symptoms \=3, AND one negative symptom \>3, or two or more negative symptoms \=3 on the PANSS
•4\. Medically and psychiatrically stable (in the opinion of the investigator) and no significant relapse of schizophrenia (i.e. requiring hospitalisation) for the 2 months before admission
•5\. On a stable dose of one or two antipsychotic drugs (excluding clozapine) for 1 month before screening
•6\. Agree to use appropriate contraception
•7\. Sufficient understanding of the nature of the trial and any hazards of participating in it. Ability to communicate satisfactorily with the investigator and to participate in, and comply with the requirements of, the entire trial.
•8\. Willingness to give written consent to participate after reading the information and consent form, and after having the opportunity to discuss the trial with the investigator or his delegate
•9\. Capacity to provide informed consent, as judged by an investigator

Exclusion Criteria

•2\. Severely underweight, or morbidly obese, as judged by the investigator
•3\. Clinically relevant abnormal history, physical findings, ECG, or laboratory values at the pre\-trial screening assessment that could interfere with the objectives of the trial or the safety of the subject
•4\. Presence of acute or chronic illness or history of chronic illness sufficient to invalidate the subject’s participation in the trial or make it unnecessarily hazardous
•5\. Impaired endocrine, cardiac, pulmonary, thyroid, haematological, hepatic, respiratory, neurological, immunological or renal function, or another major disease (e.g. cancer) deemed clinically significant at the time of the study
•6\. Type 1 diabetes or type 2 diabetes requiring therapeutic intervention (type 2 diabetes controlled by diet alone is permitted if HbA1c \<7%)
•7\. History of epilepsy or seizures (except febrile seizures in childhood)
•8\. Surgery (eg stomach bypass) or medical condition that might significantly affect the absorption of medicines
•9\. Homicidal ideation or intent, as judged by an investigator; suicidal ideation, with some intent to act, within 6 months before admission, as judged by an investigator, or based response in the C\-SSRS (positive response to questions 4 or 5 of the suicidal ideation section); or history of suicidal behavior within the year before admission
•10\. Moderate or severe depression or generalised anxiety as indicated by a score of \=11 out of 21 in either subscales of the Hospital Anxiety and Depression Scale (HADS)
•11\. Current use of CNS drug that could potentially interfere with the mode of action of AUT00206 or certain drugs which have significant interactions with CYP3A4, CYP2C9, and 2C19