Using brain stimulation to treat depression in schizophrenia patients
Therapeutic Effect of Repetitive Transcranial Magnetic Stimulation for Depressive, Positive and Negative Symptoms, and Physiological Indices of Schizophrenia Patients
This study is testing a new brain stimulation method to see if it can help people with schizophrenia who are also struggling with depression feel better when other treatments haven't worked.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 180 (estimated) |
| Ages | 20 Years and up |
| Sex | All |
| Sponsor | National Taiwan University Hospital Academic / other |
| Locations | 1 site (Douliu, Yunlin) |
| Trial ID | NCT05671185 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of repetitive transcranial magnetic stimulation (rTMS) on depressive symptoms in patients diagnosed with schizophrenia or schizoaffective disorder. The study focuses on patients who have not responded adequately to traditional antidepressant therapies, aiming to provide a new treatment option for those experiencing significant depressive symptoms. rTMS is a non-invasive procedure that uses magnetic fields to stimulate nerve cells in the brain, and this trial will specifically explore the efficacy of intermittent theta burst stimulation (iTBS), a newer variant of rTMS. The trial will assess changes in depressive symptoms, positive and negative symptoms of schizophrenia, and physiological indices.
Who should consider this trial
Good fit: Ideal candidates are adults aged 20 and older diagnosed with schizophrenia or schizoaffective disorder who exhibit moderate to severe depressive symptoms.
Not a fit: Patients with recent substance use disorders, significant cognitive impairments, or certain medical implants may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the quality of life for schizophrenia patients suffering from depression.
How similar studies have performed: Previous studies have shown promising results for rTMS in treating negative symptoms of schizophrenia, but the application for depressive symptoms is less explored, making this approach somewhat novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 20 years * Able to give informed consent * Diagnosed with schizophrenia or schizoaffective disorder according to DSM-5 * Has a score ≥ 7 on Calgary depression scale for schizophrenia * The principal psychotropic agents are not changed within one month of the first session of rTMS Exclusion Criteria: * DSM-5 defined substance use disorder (excluding tobacco) in the past 3 months * Have clinically relevant cognitive impairment (e.g., delirium, intellectual disability or MMSE \< 15) * With electronic and/or magnetic implants (e.g. pacemaker, implantable cardioverter defibrillator \[ICD\], cerebral shunts, cochlear implant, etc.) * With metallic or mechanic fragments (e.g., screws, plates, stents, clips, etc.) * Pregnant, or has a pregnancy plan within 3 months * With any known or history of neurological conditions including cerebral vascular accidents, epilepsy (or epileptiform waves detected by EEG prior to the first session of rTMS), brain tumor or space occupying lesion * Received rTMS or iTBS treatment within 3 months * Has a clinically significant abnormality on the screening examination that might affect safety, study participation, or confound interpretation of study results
Where this trial is running
Douliu, Yunlin
- Department of Psychiatry, National Taiwan University Hospital Yunlin Branch — Douliu, Yunlin, Taiwan (Recruiting)
Study contacts
- Principal investigator: Chia-Hao Ma, MD — Department of Psychiatry, National Taiwan University Hospital Yunlin Branch
- Study coordinator: Chia-Hao Ma, MD
- Email: chiahaoma.tw@gmail.com
- Phone: +886-5-5323911
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.