Schizophrenia and Related DisordersNCT05671185
rTMS for Depressive, Positive and Negative Symptoms, and Physiological Indices of Schizophrenia Patients
A study testing Repetitive Transcranial Magnetic Stimulation in people with Schizophrenia and Related Disorders, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Schizophrenia and Related Disorders
- What is being tested?
- Repetitive Transcranial Magnetic Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Dec 2022to Dec 2028
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Department of Psychiatry, National Taiwan University Hospital Yunlin Branch
Douliu, Yunlin, 640
Chia-Hao Ma, MD, +886-5-532-3911 ext. 7107, chiahaoma.tw@gmail.com
Chia-Hao Ma, MD
About this study
Official title: Therapeutic Effect of Repetitive Transcranial Magnetic Stimulation for Depressive, Positive and Negative Symptoms, and Physiological Indices of Schizophrenia Patients
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.
- Conditions
- Schizophrenia and Related Disorders
- Being tested
- Repetitive Transcranial Magnetic Stimulation
- Keywords
- Schizophrenia, repetitive transcranial magnetic stimulation
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repetitive Transcranial Magnetic StimulationDevice
rTMS using Magstim TMS system is delivered at the left dorsolateral prefrontal cortex
| Study group | Role | What they receive |
|---|---|---|
| conventional rTMS | Experimental | target: left DLPFC
protocol: 10Hz for 4 seconds, 120% motor threshold, 75 trains with 26-second interval, 3000 pulses per session, one session per day, five sessions per week, two weeks in total Receives: Device: Repetitive Transcranial Magnetic Stimulation |
| iTBS | Experimental | target: left DLPFC
protocol: 3 pulses at 50Hz, 90% motor threshold, repeated at 5Hz, 60 trains of 10 bursts with 8-second intervals, 1800 pulses per session, one session per day, five sessions per week, two weeks in total Receives: Device: Repetitive Transcranial Magnetic Stimulation |
| sham rTMS | Sham comparator | target: left DLPFC
sham probe, the same protocol as active conventional rTMS Receives: Device: Repetitive Transcranial Magnetic Stimulation |
| sham iTBS | Sham comparator | target: left DLPFC
sham probe, the same protocol as active iTBS Receives: Device: Repetitive Transcranial Magnetic Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Calgary Depression Scale for Schizophrenia
A 9-item scale developed for detecting major depressive episode for schizophrenia patients. Total score ranges from 0 to 27. Lower score indicates less depressive symptoms. A cut-off of 7 points yields to sensitivity of 85% and specificity of 82%.
Measured: baseline (Day 1), Day 8, Day 15, Day 29, Day 57, Day 85
Secondary outcomes (4)
Change from Baseline in Positive and Negative syndrome scale
A 30-item scale developed to evaluating positive, negative and general symptoms for schizophrenia patients. Total score ranges from 30 to 210. Lower score indicates fewer schizophrenic symptoms.
Measured: baseline (Day 1), Day 8, Day 15, Day 29, Day 57, Day 85
Change from Baseline in Negative symptoms assessment 16
A scale developed to evaluating negative symptoms for schizophrenia patients. Items are scored based on behaviors during the interview (items 1-4, 6, 7, 9, 11, 15, 16) or previous 7 days (items 5, 8, 10, 12-14) on a 6-point scale from 1 to 6. The NSA-16 domain scores are the sum of item scores in each domain i.e. communication (min score 4, max score 24), emotion/affect (min 3, max 18), social involvement (min 3, max 18), motivation (min 4, max 24), and retardation (min 2, max 12); with higher scores denoting more severe negative symptoms in schizophrenia.
Measured: baseline (Day 1), Day 8, Day 15, Day 29, Day 57, Day 85
Change from Baseline in Clinical global impression
A scale for primary-care psychiatrist to evaluate global symptom severity of a patient in comparison with others with same diagnosis. Lower score indicates less severe illness.
Measured: baseline (Day 1), Day 8, Day 15, Day 29, Day 57, Day 85
Change from Baseline in Self-Reported Graphic version of the Personal and Social Performance Scale
A 22-item self-rated scale for schizophrenia patients, which includes four domains, i.e., global function (6 items, total scores 6-18), personal and social performance (5 items, total scores 5-15), self-care (6 items, total scores 6-18) and disturbing behaviors (5 items, total scores 5-15). Lower score indicates less severe illness.
Measured: baseline (Day 1), Day 8, Day 15, Day 29, Day 57, Day 85
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2023
- Study start1 Dec 2022
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Schizophrenia and Related DisordersStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chia-Hao Ma, MD, Principal investigator, Department of Psychiatry, National Taiwan University Hospital Yunlin Branch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05671185
- Sponsor's protocol ID
- 202210011DINC
- Status last verified
- Jan 2026
- First submitted
- 18 Dec 2022
- Last updated
- 22 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Effect of Repetitive Transcranial Magnetic Stimulation for Depressive, Positive and Negative Symptoms, and Physiological Indices of Schizophrenia Patients
- ClinicalTrials.gov ID
- NCT05671185
- Acronym / sponsor ID
- 202210011DINC
- Conditions
- Schizophrenia and Related Disorders
- Keywords
- Schizophrenia, repetitive transcranial magnetic stimulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 4 Jan 2023 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| conventional rTMS | Experimental | Device: Repetitive Transcranial Magnetic Stimulationtarget: left DLPFC protocol: 10Hz for 4 seconds, 120% motor threshold, 75 trains with 26-second interval, 3000 pulses per session, one session per day, five sessions per week, two weeks in total |
| iTBS | Experimental | Device: Repetitive Transcranial Magnetic Stimulationtarget: left DLPFC protocol: 3 pulses at 50Hz, 90% motor threshold, repeated at 5Hz, 60 trains of 10 bursts with 8-second intervals, 1800 pulses per session, one session per day, five sessions per week, two weeks in total |
| sham rTMS | Sham comparator | Device: Repetitive Transcranial Magnetic Stimulationtarget: left DLPFC sham probe, the same protocol as active conventional rTMS |
| sham iTBS | Sham comparator | Device: Repetitive Transcranial Magnetic Stimulationtarget: left DLPFC sham probe, the same protocol as active iTBS |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
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 StimulationrTMS using Magstim TMS system is delivered at the left dorsolateral prefrontal cortex | Device | conventional rTMS, iTBS, sham iTBS, sham rTMS |
Primary outcome
Change from Baseline in Calgary Depression Scale for Schizophrenia
Time frame: baseline (Day 1), Day 8, Day 15, Day 29, Day 57, Day 85
A 9-item scale developed for detecting major depressive episode for schizophrenia patients. Total score ranges from 0 to 27. Lower score indicates less depressive symptoms. A cut-off of 7 points yields to sensitivity of 85% and specificity of 82%.
4 secondary outcomes
Change from Baseline in Positive and Negative syndrome scale
Time frame: baseline (Day 1), Day 8, Day 15, Day 29, Day 57, Day 85
Change from Baseline in Negative symptoms assessment 16
Time frame: baseline (Day 1), Day 8, Day 15, Day 29, Day 57, Day 85
Change from Baseline in Clinical global impression
Time frame: baseline (Day 1), Day 8, Day 15, Day 29, Day 57, Day 85
Change from Baseline in Self-Reported Graphic version of the Personal and Social Performance Scale
Time frame: baseline (Day 1), Day 8, Day 15, Day 29, Day 57, Day 85
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 22 Jan 2026.
Related trials for Schizophrenia and Related Disorders
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 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
Recruiting
REACH Study (Recovery Environments: Assessing Cognitive & Brain Health in Community Mental Health)
Schizophrenia, Schizo Affective Disorder
RecruitingPhase 3
Safety and Tolerability Trial of Lumateperone in Pediatric Patients With Schizophrenia, Bipolar Disorder or Autism Spectrum Disorder
Schizophrenia, Bipolar Disorder
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.
Chia-Hao Ma, MD principal investigator
Department of Psychiatry, National Taiwan University Hospital Yunlin Branch
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 in people with Schizophrenia and Related Disorders, run by National Taiwan University Hospital at 1 site in Taiwan.
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 5 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 22 Jan 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 Taiwan. 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. Some participants in this study may receive a placebo. 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 Chia-Hao Ma, MD (+886-5-5323911 ext. 7107, chiahaoma.tw@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Calgary Depression Scale for Schizophrenia (time frame: baseline (Day 1), Day 8, Day 15, Day 29, Day 57, Day 85). 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 22 Jan 2026.