NCT05671185

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
31mo left

Started Dec 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress57%
Dec 2022Dec 2028

Study Start

First participant enrolled

December 1, 2022

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

December 18, 2022

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 4, 2023

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

January 22, 2026

Status Verified

January 1, 2026

Enrollment Period

6 years

First QC Date

December 18, 2022

Last Update Submit

January 20, 2026

Conditions

Schizophrenia and Related Disorders

Keywords

Schizophreniarepetitive transcranial magnetic stimulation

Outcome Measures

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%.

    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

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

  • Change from Baseline in Negative symptoms assessment 16

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

  • Change from Baseline in Clinical global impression

    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

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

Other Outcomes (4)

  • Change from Baseline in Physiological Parameters - Heart Rate Variability

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

  • Change from Baseline in Physiological Parameters - Skin Conductance

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

  • Change from Baseline in Physiological Parameters - Body Temperature

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

  • +1 more other outcomes

Study Arms (4)

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

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

Device: Repetitive Transcranial Magnetic Stimulation

sham rTMS

SHAM COMPARATOR

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

Device: Repetitive Transcranial Magnetic Stimulation

sham iTBS

SHAM COMPARATOR

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

Device: Repetitive Transcranial Magnetic Stimulation

Interventions

Repetitive Transcranial Magnetic StimulationDEVICE

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

conventional rTMSiTBSsham iTBSsham rTMS

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Psychiatry, National Taiwan University Hospital Yunlin Branch

Douliu, Yunlin, 640, Taiwan

RECRUITING

MeSH Terms

Conditions

Schizophrenia

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Study Officials

  • Chia-Hao Ma, MD

    Department of Psychiatry, National Taiwan University Hospital Yunlin Branch

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chia-Hao Ma, MD

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 18, 2022

First Posted

January 4, 2023

Study Start

December 1, 2022

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2028

Last Updated

January 22, 2026

Record last verified: 2026-01

Locations

TW(1)