Cognitive Impairment Characteristics and Biological Mechanisms in Untreated Severe Mental Illness
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 230
- 试验地点
- 1
- 主要终点
- Cognitive Function
研究概览
简要总结
Patients with Severe Mental Illness (SMI) frequently exhibit cognitive impairment of varying degrees, involving multiple cognitive domains. These domains include working memory, attention/vigilance, verbal learning and memory, visual learning and memory, reasoning and problem-solving, processing speed, and social cognition. The severity of this impairment often predicts poorer treatment adherence and serves as a crucial indicator of a patient's capacity for independent living and social reintegration. Research into the mechanisms underlying cognitive impairment offers robust theoretical support for therapeutic interventions in SMI and remains a major focus in psychiatry. However, cognitive impairment is a complex phenomenon; studies focusing on any single cognitive dimension can only reveal partial characteristics and often lack disease specificity. Therefore, there is an urgent need to integrate multiple technical modalities, focusing on a specific biological pathway related to the symptoms of cognitive impairment, to deeply elucidate the process of its onset and to screen for reliable biomarkers. This study will recruit untreated SMI patients and healthy community controls. Upon enrollment, participants will undergo comprehensive assessments including psychiatric symptom evaluation, cognitive function testing, Electroencephalography (EEG), Magnetic Resonance Imaging (MRI), and collection of research blood samples. A follow-up assessment will be conducted at 12 weeks, re-evaluating psychiatric symptoms, cognitive functions, and EEG, while collecting follow-up blood samples and medication records. By integrating these assessment indicators, we aim to identify the potential biological mechanisms underlying cognitive dysfunction in untreated SMI patients, construct a predictive and identification model for cognitive impairment, and explore the concomitant changes in biological markers during the evolution of cognitive impairment through longitudinal follow-up, thus paving the way for prospective targeted interventions.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 18-65 years;
- •Matched to enrolled untreated patients in terms of age, sex, educational attainment, and place of residence (urban or rural).
排除标准
- •Psychotic symptoms caused by a general medical condition or substance use;
- •A history of mental retardation (estimated IQ below 70), dementia, head trauma, or brain disease, a history of seizures (epilepsy), or any history of violent or suicidal tendencies;
- •Any factor that prevents the participant from providing informed consent or participating in the study.
研究组 & 干预措施
Untreated Severe Mental Illness (SMI) Patients
We will enroll 150 patients who meet the following inclusion criteria: a current or past episode of a psychotic disorder meeting DSM-5 diagnostic criteria, including Schizophrenia, Schizoaffective Disorder, Acute and Transient Psychotic Disorder, Schizophreniform Disorder, Delusional Disorder, Other Specified or Unspecified Psychotic Disorder, or Bipolar Disorder with psychotic features; age between 18 and 65 years, inclusive; and willingness to participate and sign the informed consent form (ICF); in addition, untreated patients must meet the following specific criteria: no lifetime exposure to antipsychotic medication, or continuous use of antipsychotic medication for a period not exceeding 3 days, or a course of illness exceeding 5 years with no antipsychotic use in the last 5 years and a total lifetime cumulative use of antipsychotic medication of less than 30 days; traditional Chinese medicine used for treating psychotic symptoms will not be counted as antipsychotic medication.
Healthy Control
We will include 80 healthy controls who meet the following criteria: aged 18-65 years and matched to enrolled untreated patients in terms of age, sex, educational attainment, and place of residence (urban or rural).
结局指标
主要结局
Cognitive Function
时间窗: Baseline, week12
Cognitive function will be assessed using the MATRICS Consensus Cognitive Battery (MATRICS-CN). The following domains will be measured: processing speed, verbal learning, working memory, reasoning and problem-solving, visual learning, and attention/alertness. It possesses excellent psychometric properties, correlates with functional outcomes, and is brief, easy to administer, can be used for home-based assessments, is acceptable to participants, and has domain "robustness." The MATRICS-CN has been translated into Chinese and is available for purchase from PAR, Inc.
次要结局
- Positive and Negative Symptom Scale (PANSS)(Baseline, week12)
- Young Mania Rating Scale (YMRS)(Baseline, week12)
- Montgomery-Åsberg Depression Rating Scale (MADRS)(Baseline, week12)
- Global Assessment of Functioning (GAF) Scale(Baseline, week12)
- Antisaccade Task Error Rate(Baseline, week12)
- Auditory Paired Stimuli P50 Suppression Ratio(Baseline, week12)
- Auditory Oddball P300 Event-Related Potential Amplitude and Latency(Baseline, week12)
- Resting-State EEG Spectral Power in Theta and Alpha Bands(Baseline, week12)
- Gray Matter Volume from Structural MRI(Baseline, week12)
- Fractional Anisotropy from Diffusion Tensor Imaging (DTI)(Baseline, week12)
- Amplitude of Low-Frequency Fluctuations (ALFF) from Resting-State fMRI(Baseline, week12)
- Resting-State Functional Connectivity (Seed-Based)(Baseline, week12)