ISRCTN23256704进行中（未招募）未知
Psychosis Immune Mechanism Stratified Medicine Trial: The PIMS Trial
niversity of Bristol0 个研究点目标入组 120 人开始时间: 2022年7月13日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 120
研究概览
简要总结
2023 Protocol article in https://pubmed.ncbi.nlm.nih.gov/36963796/ (added 10/05/2023)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Inclusion Criteria for All Participants
- •1. Able and willing to give informed consent, including consent to share information with the participant’s General Practitioner (GP) and to access secondary care and GP records.
- •2. Able to understand written and spoken English.
- •3. Willing to consent to blood sampling.
- •4. Willing to abstain from strenuous exercise for 72 hours before the assessment visits.
- •5. Age: 18 - 40 years (inclusive) at the time of eligibility assessment.
- •Additional Inclusion Criteria for Neuroimaging
- •6. Able and willing to consent to MRI scanning.
- •Additional Inclusion Criteria for Healthy Controls
- •7. No current or lifetime psychiatric diagnosis.
- •Additional Inclusion Criteria for All Individuals with Psychosis
- •8. Diagnosis of psychosis: meet ICD-10 criteria for a diagnosis of schizophrenia and related psychoses (ICD-10 code F20, F22, F25, F28, F29) at the time of eligibility assessment and within three years of first diagnosis of psychotic disorder.
- •9. On stable treatment regime with no recent (within 2 weeks) initiation, cessation, or change in class of antipsychotic medication.
- •10. No indication of other reason for preclusion into research (e.g., risk to others) as determined by their clinical team.
- •11. Positive and Negative Syndrome Scale (PANSS) item score >=3 on P1 (delusions), P2 (conceptual disorganisation), P3 (hallucinatory behaviour), OR P6 (suspiciousness/persecution).
- •Additional Inclusion Criteria for Intervention Group
- •12. Evidence of immune activation: required at eligibility and at baseline visit to enter the study. Serum IL-6 level >=0.7pg/ml will be used as a measure of immune activation.
- •13. Inflammation-related symptom: Temporal Experience of Pleasure Scale (TEPS) anticipatory pleasure score <=41 (based upon item numbers 1, 3, 7, 11, 12, 14, 15, 16, 17, and 8) and consummatory pleasure score <=36 (based upon item numbers 2, 4, 5, 6, 8, 9, 10, and 13).
- •14. COVID-19 immunity: evidence of COVID-19 immunity required prior to infusion. Immunity will be confirmed before randomisation using evidence of vaccination and antibody titre test.
- •Additional Inclusion Criteria for Patients with Psychosis and No Inflammation
- •15. No evidence of immune activation: required at eligibility and at baseline visit to enter the study. Serum/plasma IL-6 level <0.7pg/ml will be used to confirm no evidence of immune activation.
排除标准
- •Exclusion Criteria for All Participants
- •1. Pregnancy (confirmed by urine pregnancy test) or breast feeding.
- •2. Body mass index (BMI) >35 kg/m² (i.e., WHO obesity class II or above).
- •3. Current or lifetime diagnosis of antisocial personality disorder, autism or other neurodevelopmental disorder, major traumatic brain injury (determined by Chief Investigator).
- •4. Currently active diagnosed eating disorder likely to compromise ability to take part (determined by Chief Investigator).
- •5. History of alcohol or substance use disorder (abuse/dependence) within six months prior to eligibility assessment (nicotine and caffeine dependence are not exclusionary).
- •6. Current use of medication likely to compromise interpretation of immunological data (including, but not limited to, antibiotics, regular non-steroidal anti-inflammatory drugs, oral/injectable corticosteroids – or any other substances to be determined by the Chief Investigator).
- •7. Known active current or history of recurrent bacterial, viral, fungal, mycobacterial or other opportunistic infections.
- •8. Current or past infection including tests for TB, Hepatitis B, Hepatitis C, VZV or HIV confirmed by blood test. Chest X-ray will be also done to exclude TB.
- •9. Any major episode of infection requiring hospitalisation or treatment with IV antibiotics within 4 weeks of eligibility assessment.
- •10. Unstable cardiac, pulmonary, renal, hepatic, endocrine, hematologic, or active infectious disease, including current or prior malignancy.
- •11. Diverticulitis, inflammatory bowel disease, or uncontrolled gastric/duodenal ulcer.
- •12. Rheumatic autoimmune disease, mixed connective tissue disease, scleroderma, polymyositis, or significant systemic involvement secondary to rheumatoid arthritis.
- •13. Current and active ischemic heart disease, e.g., unstable angina.
- •14. Uncontrolled hypertension defined as systolic blood pressure >170 or diastolic blood pressure >110.
- •15. History of severe allergic or anaphylactic reactions to human, humanized or murine monoclonal antibodies.
- •16. No history of chicken pox infection or no history of varicella zoster vaccination.
- •Additional Exclusion Criteria for Neuroimaging
- •17. Contraindications to MRI scanning.
研究者
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