CClinicalTrials.gg
RecruitingNCT05671185Updated Jan 22, 2026

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

An interventional study of Repetitive Transcranial Magnetic Stimulation in Schizophrenia and Related Disorders, sponsored by National Taiwan University Hospital. Recruiting at 1 site in Taiwan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2026-01-22.

Sponsored by National Taiwan University Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Dec 2022; still recruiting 3 years 10 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
180
Allocation
Randomized
Ages
20 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Schizophrenia and Related Disorders

Browse trials for

Keywords

  • Schizophrenia
  • repetitive transcranial magnetic stimulation
03

In context

Schizophrenia

3,471 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.

This study's planned enrollment of 180 is above the median of 70 across 2,872 interventional studies indexed under Schizophrenia.

Browse Schizophrenia studies →

Lead sponsor

National Taiwan University Hospital is the lead sponsor of 2,563 studies on the registry; 569 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
180 participants (estimated)

Study arms

  • Experimental
    conventional rTMS

    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

    Device: Repetitive Transcranial Magnetic Stimulation

  • Experimental
    iTBS

    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

    Device: Repetitive Transcranial Magnetic Stimulation

  • Sham comparator
    sham rTMS

    target: left DLPFC sham probe, the same protocol as active conventional rTMS

    Device: Repetitive Transcranial Magnetic Stimulation

  • Sham comparator
    sham iTBS

    target: left DLPFC sham probe, the same protocol as active iTBS

    Device: Repetitive Transcranial Magnetic Stimulation

Interventions

  • DeviceRepetitive Transcranial Magnetic Stimulation

    rTMS using Magstim TMS system is delivered at the left dorsolateral prefrontal cortex

06

What researchers measure

Primary outcomes

  1. 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%.

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

Secondary outcomes

  1. 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.

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

  2. 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.

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

  3. 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.

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

  4. 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.

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

Other outcomes

  1. Change from Baseline in Physiological Parameters - Heart Rate Variability

    Measurement of parasympathetic activity.

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

  2. Change from Baseline in Physiological Parameters - Skin Conductance

    Measurement of sympathetic activity.

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

  3. Change from Baseline in Physiological Parameters - Body Temperature

    Measurement of autonomic nervous system.

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

  4. Change from Baseline in Physiological Parameters - Respiratory Rate

    Measurement of autonomic nervous system.

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

07

Study locations

1 of 1 sites recruiting
  • Department of Psychiatry, National Taiwan University Hospital Yunlin Branch
    Douliu, Yunlin, 640, Taiwan
    • Chia-Hao Ma, MD · Contact · chiahaoma.tw@gmail.com · +886-5-532-3911
    • Chia-Hao Ma, MD · Principal investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05671185
Lead sponsor
National Taiwan University Hospital
Responsible party
Sponsor
First posted
Jan 4, 2023
Start date
Dec 1, 2022
Primary completion
Dec 2028 (estimated)
Completion
Dec 2028 (estimated)
Last update
Jan 22, 2026

Study contacts

Chia-Hao Ma, MD
Contact
chiahaoma.tw@gmail.com
+886-5-5323911 ext. 7107
Chia-Hao Ma, MD
principal investigator · Department of Psychiatry, National Taiwan University Hospital Yunlin Branch

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion