NCT07448675

Cognitive Impairment Characteristics and Biological Mechanisms in Untreated Severe Mental Illness

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 230 (estimated)
• Sponsor: Tianjin Anding Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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

Timeline

• Start date: 2023-02-07
• Primary completion: 2026-06-01
• Completion: 2026-06-30
• First posted: 2026-03-04
• Last updated: 2026-03-04

Locations

1 site across 1 country: China