RecruitingNot Applicable

rTMS for Depressive, Positive and Negative Symptoms, and Physiological Indices of Schizophrenia Patients

Taiwan180 participantsStarted 2022-12-01

Plain-language summary

Around 40% of schizophrenia patients present depressive symptoms, which are associated with elevated suicide and violence risk and poor prognosis and quality of life. Recent meta-analysis showed the effect size of antidepressants for depressive symptoms of schizophrenia patients was as low as 0.25, so new therapeutic approach is warranted. Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive, anesthesia-free brain stimulation therapy for treatment refractory depression. Currently, rTMS is classified as high-frequency stimulation (\>5Hz, usually 10Hz or 20Hz) and low-frequency inhibition (usually 1Hz). Intermittent theta burst stimulation (iTBS) is a new variant of rTMS, with stimulation frequency as high as 50Hz. Compared with high-frequency rTMS, iTBS has similar therapeutic effect and shorter stimulation duration. Up to now, studies exploring treatment effect of rTMS or iTBS for schizophrenia patients mainly focused on negative symptoms rather than depressive symptoms. Therefore, this study aims to explore treatment effect of rTMS or iTBS of depressive symptoms, negative symptoms, cognitive function and physiological indices for schizophrenia patients.

Who can participate

Age range

20 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change from Baseline in Calgary Depression Scale for Schizophrenia

Timeframe: baseline (Day 1), Day 8, Day 15, Day 29, Day 57, Day 85

Trial details

NCT IDNCT05671185

SponsorNational Taiwan University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-12

Contact for this trial

Chia-Hao Ma, MD

+886-5-5323911 chiahaoma.tw@gmail.com

View on ClinicalTrials.gov More Schizophrenia and Related Disorders trials