SchizophreniaNCT07444463
Brain Network Mechanisms of Cognitive Impairments in Major Psychiatric Disorders and Their Clinical Applications
A study testing repetitive transcranial magnetic stimulation (rTMS) in people with Schizophrenia and Bipolar Disorder, run by Central South University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia, Bipolar Disorder, Major Depressive Disorder (MDD)
- What is being tested?
- repetitive transcranial magnetic stimulation (rTMS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2027to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 1, 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
- 2, For Healthy Controls:
Show all 11Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Second Xiangya Hospital
Changsha, Hunan, 410011
haohao Yan, Ph.D., 86+073185360921, yanhaohao1995@gmail.com
About this study
Official title: Study on the Brain Network Mechanisms of Cognitive Impairments in Major Psychiatric Disorders and Their Application in Cognitive Assessment, Diagnosis, and Precision Treatment
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.
- Being tested
- repetitive transcranial magnetic stimulation (rTMS)
- Keywords
- schizophrenia, cognitive impairments, brain imaging, bipolar disorder, major depressive disorder
- Medical subject headings
- Schizophrenia, Bipolar Disorder, Depressive Disorder, Major, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
repetitive transcranial magnetic stimulation (rTMS)Device
Patients will receive repetitive transcranial magnetic stimulation (rTMS) targeting the dorsolateral prefrontal cortex (dlPFC).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive changes
Cognitive Changes Assessed with the MATRICS Consensus Cognitive Battery (MCCB) after Repetitive Transcranial Magnetic Stimulation (rTMS) Intervention
Measured: From enrollment to the end of treatment at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2026
- Study start1 Jan 2027 (estimated)
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guo Wenbin, Central South University
- Investigators
- Wenbin Guo, Ph.D., Study chair, 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.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07444463
- Sponsor's protocol ID
- 20270101GWB
- Status last verified
- Mar 2026
- First submitted
- 26 Feb 2026
- Last updated
- 4 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Brain Network Mechanisms of Cognitive Impairments in Major Psychiatric Disorders and Their Application in Cognitive Assessment, Diagnosis, and Precision Treatment
- ClinicalTrials.gov ID
- NCT07444463
- Acronym / sponsor ID
- 20270101GWB
- Keywords
- schizophrenia, cognitive impairments, brain imaging, bipolar disorder, major depressive disorder
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Central South UniversityUniversity, hospital or other
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 3 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Patients with schizophrenia | Experimental | Device: repetitive transcranial magnetic stimulation (rTMS)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. |
| Patients with bipolar disorder | Experimental | Device: repetitive transcranial magnetic stimulation (rTMS)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. |
| Patients with major depressive disorder | Experimental | Device: repetitive transcranial magnetic stimulation (rTMS)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. |
| 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 1, 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| repetitive transcranial magnetic stimulation (rTMS)Patients will receive repetitive transcranial magnetic stimulation (rTMS) targeting the dorsolateral prefrontal cortex (dlPFC). | Device | Patients with bipolar disorder, Patients with major depressive disorder, Patients with schizophrenia |
Primary outcome
Cognitive changes
Time frame: From enrollment to the end of treatment at 8 weeks
Cognitive Changes Assessed with the MATRICS Consensus Cognitive Battery (MCCB) after Repetitive Transcranial Magnetic Stimulation (rTMS) Intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Schizophrenia
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Deep Brain Stimulation for Treatment-Resistant Schizophrenia
Treatment Resistant Disorders
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Active, not recruiting
Designing and Evaluating a Classroom-Based Mental Health Programme for Adolescents.
Mental Health Promotion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Wenbin Guo, Ph.D. study chair
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing repetitive transcranial magnetic stimulation (rTMS) in people with Schizophrenia and Bipolar Disorder, run by Central South University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wenbin Guo, Ph.D. (+8673185360921, guowenbin76@csu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive changes (time frame: From enrollment to the end of treatment at 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2026.