ISRCTN10534853已完成1 期
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 个研究点目标入组 24 人开始时间: 2022年2月8日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
研究概览
简要总结
2022 Results article in https://pubmed.ncbi.nlm.nih.gov/36164687/ (added 20/12/2022)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Male
入选标准
- •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
排除标准
- •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
- •12. Presence or history of severe adverse reaction to any drug or a history of sensitivity to the study medicine excipients, or modulators of voltage-gated potassium channels
- •13. Participation in another clinical trial of a new chemical entity or a prescription medicine
- •within the previous 30 days, or 5 half-lives of the study medicine (whichever is longer)
- •14. History of drug or alcohol dependence in the year before admission
- •15. Uncontrolled hypertension or hypertension treated with a prohibited medicine
- •16. Corrected QT interval (QTcB) <330 msec or >450 msec at the screening examination, unless judged not clinically significant by an investigator
- •17. Likelihood that the subject will not comply with the requirements of the protocol
- •18. Positive test for hepatitis B, hepatitis C or HIV
- •19. Loss of more than 400 ml blood during the 3 months before the admission, e.g. as a blood donor
- •20. Objection by a General Practitioner (GP), or another doctor responsible for their treatment, to the patient entering the trial
- •Additional exclusion criteria for PET and MRI only:
- •1. Exposure to radiation, such that in combination with this trial, exposure would be more than 10 mSv within the previous 12 months (PET exclusion only)
- •2. Presence of a cardiac pacemaker or other implanted electronic device
- •3. Contradictions to having an MRI scan, such as (but not limited to) ferromagn
研究者
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