Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05671185

rTMS 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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Schizophrenia and Related Disorders Mental Disorders Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Psychiatry, National Taiwan University Hospital Yunlin Branch

Douliu, Yunlin, 640, Taiwan

Location status: Recruiting

Location contact

Chia-Hao Ma, MD

CONTACT

[email protected]

+886-5-532-3911 ext. 7107

Chia-Hao Ma, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

repetitive transcranial magnetic stimulation

Device

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

Primary outcomes

  1. 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%.

Secondary outcomes

  1. Change from Baseline in Positive and Negative syndrome scale

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

    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.

  2. Change from Baseline in Negative symptoms assessment 16

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

    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.

  3. Change from Baseline in Clinical global impression

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

    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.

  4. 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

    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.

Other outcomes

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

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

    Measurement of parasympathetic activity.

  2. Change from Baseline in Physiological Parameters - Skin Conductance

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

    Measurement of sympathetic activity.

  3. Change from Baseline in Physiological Parameters - Body Temperature

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

    Measurement of autonomic nervous system.

  4. Change from Baseline in Physiological Parameters - Respiratory Rate

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

    Measurement of autonomic nervous system.

Study contacts

Contact information is provided by the study sponsor or research team.

Chia-Hao Ma, MD

CONTACT

[email protected]

+886-5-5323911 ext. 7107

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

Therapeutic Effect of Repetitive Transcranial Magnetic Stimulation for Depressive, Positive and Negative Symptoms, and Physiological Indices of Schizophrenia Patients

Important dates

Study start
2022
Primary completion
2028
Study completion
2028
First posted
Jan 4, 2023
Registry last updated
Jan 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.