- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07444463
Brain Network Mechanisms of Cognitive Impairments in Major Psychiatric Disorders and Their Clinical Applications
Study on the Brain Network Mechanisms of Cognitive Impairments in Major Psychiatric Disorders and Their Application in Cognitive Assessment, Diagnosis, and Precision Treatment
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Wenbin Guo, Ph.D.
- Phone Number: +8673185360921
- Email: guowenbin76@csu.edu.cn
Study Locations
-
-
Hunan
-
Changsha, Hunan, China, 410011
- Second Xiangya Hospital
-
Contact:
- haohao Yan, Ph.D.
- Phone Number: 86+073185360921
- Email: yanhaohao1995@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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:
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
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Patients with schizophrenia
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 will receive repetitive transcranial magnetic stimulation (rTMS) targeting the dorsolateral prefrontal cortex (dlPFC).
|
|
Experimental: Patients with bipolar disorder
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 will receive repetitive transcranial magnetic stimulation (rTMS) targeting the dorsolateral prefrontal cortex (dlPFC).
|
|
Experimental: Patients with major depressive disorder
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. |
Patients will receive repetitive transcranial magnetic stimulation (rTMS) targeting the dorsolateral prefrontal cortex (dlPFC).
|
|
No Intervention: healthy controls
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
From enrollment to the end of treatment at 8 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: 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 record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Bipolar and Related Disorders
- Schizophrenia Spectrum and Other Psychotic Disorders
- Mental Disorders
- Neurocognitive Disorders
- Cognition Disorders
- Mood Disorders
- Depressive Disorder
- Schizophrenia
- Cognitive Dysfunction
- Bipolar Disorder
- Depressive Disorder, Major
- Therapeutics
- Magnetic Field Therapy
- Transcranial Magnetic Stimulation
Other Study ID Numbers
- 20270101GWB
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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