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Cognitive Impairment Characteristics and Biological Mechanisms in Untreated Severe Mental Illness

NCT07448675 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 230

Last updated 2026-03-04

No results posted yet for this study

Summary

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.

Conditions

  • Patients With Severe Mental Illness

Sponsors & Collaborators

  • Tianjin Anding Hospital

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-02-07
Primary Completion
2026-06-01
Completion
2026-06-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07448675 on ClinicalTrials.gov