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.
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
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.)
Parallel
Repetitive Transcranial Magnetic Stimulation
DevicerTMS using Magstim TMS system is delivered at the left dorsolateral prefrontal cortex
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%.
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.
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.
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.
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.
Change from Baseline in Physiological Parameters - Heart Rate Variability
Measurement of parasympathetic activity.
Change from Baseline in Physiological Parameters - Skin Conductance
Measurement of sympathetic activity.
Change from Baseline in Physiological Parameters - Body Temperature
Measurement of autonomic nervous system.
Change from Baseline in Physiological Parameters - Respiratory Rate
Measurement of autonomic nervous system.
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