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Набор по приглашению NCT07448675

Cognitive Impairment Characteristics and Biological Mechanisms in Untreated Severe Mental Illness

— Наблюдательное Patients With Severe Mental Illness

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Patients With Severe Mental Illness. Базовые параметры: 18 лет — 65 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай
Следующий шаг
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Обзор

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.

Первичные конечные точки

  • Cognitive Function [Срок оценки: Baseline, week12]
Вторичные конечные точки (12)
  • Positive and Negative Symptom Scale (PANSS) [Срок оценки: Baseline, week12]
  • Young Mania Rating Scale (YMRS) [Срок оценки: Baseline, week12]
  • Montgomery-Åsberg Depression Rating Scale (MADRS) [Срок оценки: Baseline, week12]
  • Global Assessment of Functioning (GAF) Scale [Срок оценки: Baseline, week12]
  • Antisaccade Task Error Rate [Срок оценки: Baseline, week12]
  • Auditory Paired Stimuli P50 Suppression Ratio [Срок оценки: Baseline, week12]
  • Auditory Oddball P300 Event-Related Potential Amplitude and Latency [Срок оценки: Baseline, week12]
  • Resting-State EEG Spectral Power in Theta and Alpha Bands [Срок оценки: Baseline, week12]
  • Gray Matter Volume from Structural MRI [Срок оценки: Baseline, week12]
  • Fractional Anisotropy from Diffusion Tensor Imaging (DTI) [Срок оценки: Baseline, week12]
  • Amplitude of Low-Frequency Fluctuations (ALFF) from Resting-State fMRI [Срок оценки: Baseline, week12]
  • Resting-State Functional Connectivity (Seed-Based) [Срок оценки: Baseline, week12]

Критерии участия

Критерии включения

  • Aged 18-65 years;
  • Matched to enrolled untreated patients in terms of age, sex, educational attainment, and place of residence (urban or rural).

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Китай · 1 центр
  • Tianjin Anding Hospital — Тяньцзинь

Идентификаторы

NCT: NCT07448675 · SMI-UT

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗