rTMS for Depressive, Positive and Negative Symptoms, and Physiological Indices of Schizophrenia Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Repetitive Transcranial Magnetic Stimulation.
- Who it may be relevant to
- Registry conditions: Schizophrenia and Related Disorders. Basic parameters: from 20 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Taiwan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Therapeutic Effect of Repetitive Transcranial Magnetic Stimulation for Depressive, Positive and Negative Symptoms, and Physiological Indices of Schizophrenia Patients
Overview
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.
Interventions
- Device Repetitive Transcranial Magnetic Stimulation
rTMS using Magstim TMS system is delivered at the left dorsolateral prefrontal cortex
Primary outcome measures
- Change from Baseline in Calgary Depression Scale for Schizophrenia [Time frame: baseline (Day 1), Day 8, Day 15, Day 29, Day 57, Day 85]
Secondary outcome measures (4)
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Taiwan · 1 center
- Department of Psychiatry, National Taiwan University Hospital Yunlin Branch — Douliu, Yunlin
Identifiers
NCT: NCT05671185 · 202210011DINC