Computer-assisted Risk Evaluation in the Early Detection of Psychotic Disorders
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 260
- 试验地点
- 42
- 主要终点
- Structured Interview for Psychosis-Risk Syndromes (SIPS)
研究概览
简要总结
Multicenter randomized controlled trial (RCT) with artificial intelligence (AI)-staged early diagnostics and risk-adapted treatment (RAB) as interventional treatment arm and treatment-as-usual (TAU) as control treatment arm for patients with an increased clinical risk for psychosis.
详细描述
The study is a Investigator Initiated Trial (IIT)/Other clinical trial of a class 2a medical device according to article 82 medical devices regulation of the European Union.
The aim of risk-adapted treatment (RAB) arm is to reduce the number of patients with an increased clinical risk for psychosis to actually develop a manifest psychosis.
Patients assigned to the active treatment arm will receive additional in-depth clinical diagnostics including neuropsychological testing.
The AI-supported algorithm "pronia.ai" uses information from both the individual patient data of the specialized routine diagnostics as well as from in-depth clinical diagnostics.
There are two predictions, an individual quantitative assessment of the individual risk of transition to psychosis and the individual prognosis with regard to the level of psychosocial functioning 12 months after inclusion in the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The increased risk of psychosis includes either a symptomatic "ultra high-risk" stage of the Structured Interview for Psychosis-Risk Syndromes or the "Cognitive Disturbances" risk criterion of the Schizophrenia Proneness Instrument - Children and Youth and Adult versions
- •ages 16 to 40
- •Presence of a written informed consent from the patient and, if applicable, the legal guardian.
排除标准
- •manifest psychosis according to the definition of the Structured Interview for Psychosis-Risk Syndromes (according to the PRONIA-study) (At least one P-syndrome with a rating of 6 on a daily frequency and for a period of more than one week)
- •Lack of capacity to give consent (the patient lacks the capacity to consent if the individual case with regard to the specific treatment measure is excluded. Only when the physician has concrete indications that the patient's capacity to consent may be lacking, he may and must must examine it. Mental disorders (e.g. delirium, dementia, psychosis, mania, depression) or cognitive impairments can have an influence on the capacity to consent. Indications for doubts of a ability to give informed consent exist if the physician has the impression that the patient is not able to understand the provided patient information and is not able to reproduce essential information about the study in his or her own words and is not aware of the possible consequences of the proposed measures
- •Severe suicidality during the recruitment phase (CDSS items 8 ≥2)
- •A current or past neurological disease of the brain.
- •a current or past known somatic disease that potentially affects the structure or function of the brain
- •Antipsychotic medication in the indication treatment of psychotic symptoms for >30 days (cumulative number of days) at or above the starting dose for psychosis according to the current German Association for Psychiatry, Psychotherapy and Psychosomatics (DGPPN) S3 guidelines.
- •an antipsychotic medication in the indication treatment of psychotic symptoms in the 3 months prior to the initial examination (regardless of the duration of use) at or above the starting dose for psychosis according to the current DGPPN S3 guidelines
- •An inadequate level of hearing for neurocognitive testing
- •a current or past head trauma with unconsciousness (>5 min).
- •a current or past alcohol dependence (ICD-10 F10.x)
- •A current polytoxicomania (multiple substance dependence) or polytoxicomania in the past 6 months (ICD-10 F19.x)
- •Presence of medical reasons that contraindicate performance of an MRI
- •Insufficient language skills to understand the indication and the purpose of the intended examinations and interventions
- •stationary accommodation against the patient's will
研究组 & 干预措施
Standard of Care Control arm
Treatment as usual (TAU) patient will receive their usual treatment from their local physicians and therapeutic personnel.
干预措施: Treatment-as-usual (TAU) (Other)
CARE interventional treatment
AI-computerassisted prognosis of high risk psychosis profile and adapted study-specific therapy taking place in early-recognition centers.
干预措施: "pronia.ai" medical device for high risk psychosis prognosis (Device)
结局指标
主要结局
Structured Interview for Psychosis-Risk Syndromes (SIPS)
时间窗: 12-month after inclusion
Presence of psychotic syndrome (POPS) criteria as modified according to the "PRONIA" study, resulting in a score of 0= "no psychosis" or 1= "psychosis"
次要结局
- Social and occupational assessment scale SOFAS(12-month after inclusion)
- Global Functioning Role Scale (GF:R)(12-month after inclusion)
- Internalized Stigma of Mental Illness Scale (ISMI)(12-month after inclusion)
- Stigma-Stress-Scale(12-month after inclusion)
- Global Functioning Social Scale (GF:S)(12-month after inclusion)
- Self-Identification of Mental Illness Scale (SELF-I)(12-month after inclusion)
- Numeracy Scale(12-month after inclusion)
- Risk Recall Scale(12-month after inclusion)
- Client Sociodemographic and Service Receipt Inventory (CSSRI-EU)(12-month after inclusion)
- Secrecy and disclosure-related distress - scale(12-month after inclusion)
- Psychosis own health-concern single score(12-month after inclusion)
- Risk Perception Scale(12-month after inclusion)
- Brief Multidimensional Life Satisfaction Scale (BMLSS)(12-month after inclusion)
- Coming-Out with Mental Illness Scale (COMIS)(12-month after inclusion)
- Coping (Ten-Flex)(12-month after inclusion)
- Health-related quality of life (EQ-5D)(12-month after inclusion)
- Patient Satisfaction Questionnaire (ZUF-8)(12-month after inclusion)
- Secrecy-Symptoms Scale(12-month after inclusion)