Cognitive Impairment Characteristics and Biological Mechanisms in Untreated Severe Mental Illness
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Patients With Severe Mental Illness. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- Cognitive Function [Time frame: Baseline, week12]
Secondary outcome measures (12)
- Positive and Negative Symptom Scale (PANSS) [Time frame: Baseline, week12]
- Young Mania Rating Scale (YMRS) [Time frame: Baseline, week12]
- Montgomery-Åsberg Depression Rating Scale (MADRS) [Time frame: Baseline, week12]
- Global Assessment of Functioning (GAF) Scale [Time frame: Baseline, week12]
- Antisaccade Task Error Rate [Time frame: Baseline, week12]
- Auditory Paired Stimuli P50 Suppression Ratio [Time frame: Baseline, week12]
- Auditory Oddball P300 Event-Related Potential Amplitude and Latency [Time frame: Baseline, week12]
- Resting-State EEG Spectral Power in Theta and Alpha Bands [Time frame: Baseline, week12]
- Gray Matter Volume from Structural MRI [Time frame: Baseline, week12]
- Fractional Anisotropy from Diffusion Tensor Imaging (DTI) [Time frame: Baseline, week12]
- Amplitude of Low-Frequency Fluctuations (ALFF) from Resting-State fMRI [Time frame: Baseline, week12]
- Resting-State Functional Connectivity (Seed-Based) [Time frame: Baseline, week12]
Eligibility criteria
Inclusion criteria
- Aged 18-65 years;
- Matched to enrolled untreated patients in terms of age, sex, educational attainment, and place of residence (urban or rural).
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Tianjin Anding Hospital — Tianjin
Identifiers
NCT: NCT07448675 · SMI-UT