Brain Network Mechanisms of Cognitive Impairments in Major Psychiatric Disorders and Their Clinical Applications

NCT07444463 | Not Yet Recruiting

• 1 other identifier: 20270101GWB
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

Previous and our studies have shown that cognitive impairments are core symptoms of three major psychiatric disorders-schizophrenia, bipolar disorder, and major depressive disorder, and are associated with underlying brain dysfunction. However, the specific brain networks involved in cognitive impairments (cognitive impairment brain networks) in these disorders, as well as whether their neuroimaging features can be applied to cognitive assessment, diagnosis, and precision treatment, remain unclear. This study aims to identify cognitive impairment brain networks using publicly available large-scale datasets and clinical research, and to explore whether the neuroimaging features of these networks can be utilized for cognitive assessment, diagnosis, and treatment response prediction. First, a "sensitive cognitive assessment model for major psychiatric disorders" will be established through meta-analysis based on sensitive scales. Second, cognitive impairment brain networks will be identified using publicly available large-scale datasets combined with the lesion network mapping method, and their validity will be examined by assessing their non-randomness, reproducibility, symptom specificity, and disease specificity. Third, cognitive assessment and diagnostic models will be developed based on neuroimaging features of these networks. Finally, a combination of cross-sectional and longitudinal study designs will be used in a clinical trial to validate the identified networks and models, and a treatment response prediction model will be established based on the neuroimaging features of cognitive impairment brain networks. This study will advance the understanding of the neurophysiological mechanisms underlying cognitive impairment in major psychiatric disorders, promote the application of neuroimaging in psychiatric diagnosis and treatment, and improve traditional diagnostic, therapeutic, and cognitive assessment approaches.

Conditions

Schizophrenia; Bipolar Disorder; Major Depressive Disorder (MDD)

Keywords

schizophrenia; cognitive impairments; brain imaging; bipolar disorder; major depressive disorder

Outcome Measures

Primary Outcomes (1)

• Cognitive changes

  Cognitive Changes Assessed with the MATRICS Consensus Cognitive Battery (MCCB) after Repetitive Transcranial Magnetic Stimulation (rTMS) Intervention

  From enrollment to the end of treatment at 8 weeks

Study Arms (4)

Patients with schizophrenia

EXPERIMENTAL

One hundred patients with schizophrenia (SZ) who are either drug-naïve at first episode or have relapsed after discontinuing medication for more than one month will be enrolled. Before treatment, all participants will undergo demographic and clinical assessments, along with structural and resting-state functional magnetic resonance imaging (MRI) scans. After the baseline MRI scan, patients will receive repetitive transcranial magnetic stimulation (rTMS) targeting the dorsolateral prefrontal cortex (dlPFC). Upon completion of the treatment course, clinical assessments and MRI scans will be repeated.

Device: repetitive transcranial magnetic stimulation (rTMS)

Patients with bipolar disorder

EXPERIMENTAL

One hundred patients with bipolar disorder who are either drug-naïve at first episode or have relapsed after discontinuing medication for more than one month will be enrolled. Before treatment, all participants will undergo demographic and clinical assessments, along with structural and resting-state functional magnetic resonance imaging (MRI) scans. After the baseline MRI scan, patients will receive repetitive transcranial magnetic stimulation (rTMS) targeting the dorsolateral prefrontal cortex (dlPFC). Upon completion of the treatment course, clinical assessments and MRI scans will be repeated.

Device: repetitive transcranial magnetic stimulation (rTMS)

Patients with major depressive disorder

EXPERIMENTAL

One hundred patients with major depressive disorder who are either drug-naïve at first episode or have relapsed after discontinuing medication for more than one month will be enrolled. Before treatment, all participants will undergo demographic and clinical assessments, along with structural and resting-state functional magnetic resonance imaging (MRI) scans. After the baseline MRI scan, patients will receive repetitive transcranial magnetic stimulation (rTMS) targeting the dorsolateral prefrontal cortex (dlPFC). Upon completion of the treatment course, clinical assessments and MRI scans will be repeated.

Device: repetitive transcranial magnetic stimulation (rTMS)

healthy controls

NO INTERVENTION

One hundred healthy controls will be enrolled. Before the baseline assessment, all participants will undergo demographic and clinical evaluations, along with structural and resting-state functional magnetic resonance imaging (MRI) scans. Healthy controls will undergo clinical assessments and MRI scans at corresponding time points without receiving rTMS treatment.

Interventions

repetitive transcranial magnetic stimulation (rTMS) DEVICE

Patients will receive repetitive transcranial magnetic stimulation (rTMS) targeting the dorsolateral prefrontal cortex (dlPFC).

Patients with bipolar disorder; Patients with major depressive disorder; Patients with schizophrenia

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• , For Patients (SZ, BD, MDD):
• Diagnosis of schizophrenia (SZ), bipolar disorder (BD), or major depressive disorder (MDD) according to standard diagnostic criteria
• First-episode drug-naïve patients or patients who have relapsed after discontinuing medication for more than one month
• Aged 18-60 years
• Completion of at least 6 years of formal education
• , For Healthy Controls:
• Aged 18-60 years
• Completion of at least 6 years of formal education
• No current or past psychiatric disorders
• No first-degree relatives with psychiatric disorders
• No history of treatment with psychotropic medications or physical therapy for psychiatric disorders

You may not qualify if:

• Prior use of psychotropic medications or receipt of physical treatment for psychiatric disorders (for patient group)
• Contraindications to MRI scanning
• History of brain injury
• History of substance abuse
• Presence of other neurological disorders
• Presence of severe medical or systemic physical illnesses.

Sponsors & Collaborators

• Central South University: lead

Study Sites (1)

Second Xiangya Hospital

Changsha, Hunan, 410011, China

Location

MeSH Terms

Conditions

Schizophrenia; Bipolar Disorder; Depressive Disorder, Major; Cognitive Dysfunction

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Bipolar and Related Disorders; Mood Disorders; Depressive Disorder; Cognition Disorders; Neurocognitive Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Wenbin Guo, Ph.D.

  Department of Psychiatry, National Clinical Research Center for Mental Disorders, and National Center for Mental Disorders, The Second Xiangya Hospital of Central South University, Changsha 410011, Hunan, China.

  STUDY CHAIR

Central Study Contacts

Wenbin Guo, Ph.D.

CONTACT

+8673185360921; guowenbin76@csu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: We will recruit 100 patients each with schizophrenia (SZ), bipolar disorder (BD), and major depressive disorder (MDD), who are either drug-naïve at first episode or have relapsed after discontinuing medication for more than one month, as well as 100 healthy controls. Before treatment, all participants will undergo demographic and clinical assessments, along with structural and resting-state functional magnetic resonance imaging (MRI) scans. After the baseline MRI scan, patients will receive repetitive transcranial magnetic stimulation (rTMS) targeting the dorsolateral prefrontal cortex (dlPFC). Upon completion of the treatment course, clinical scale assessments and MRI scans will be repeated. Healthy controls will undergo clinical assessments and MRI scans at corresponding time points without receiving rTMS treatment.

Study Record Dates

• First Submitted: February 26, 2026
• First Posted: March 3, 2026
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: March 4, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)