Clinical trial NCT05671185: rTMS for Depressive, Positive and Negative Symptoms, and Physiological Indices of Schizophrenia Patients
Official title: Therapeutic Effect of Repetitive Transcranial Magnetic Stimulation for Depressive, Positive and Negative Symptoms, and Physiological Indices of Schizophrenia Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Schizophrenia and Related Disorders
Keywords: Schizophrenia
repetitive transcranial magnetic stimulation
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2023-01-04
Enrollment: 180
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change from Baseline in Calgary Depression Scale for Schizophrenia
timeFrame: baseline (Day 1), Day 8, Day 15, Day 29, Day 57, Day 85
Secondary outcomes:
measure: Change from Baseline in Positive and Negative syndrome scale
timeFrame: baseline (Day 1), Day 8, Day 15, Day 29, Day 57, Day 85
measure: Change from Baseline in Negative symptoms assessment 16
timeFrame: baseline (Day 1), Day 8, Day 15, Day 29, Day 57, Day 85
measure: Change from Baseline in Clinical global impression
timeFrame: baseline (Day 1), Day 8, Day 15, Day 29, Day 57, Day 85
measure: Change from Baseline in Self-Reported Graphic version of the Personal and Social Performance Scale
timeFrame: baseline (Day 1), Day 8, Day 15, Day 29, Day 57, Day 85
Other outcomes:
measure: Change from Baseline in Physiological Parameters - Heart Rate Variability
timeFrame: baseline (Day 1), Day 8, Day 15, Day 29, Day 57, Day 85
measure: Change from Baseline in Physiological Parameters - Skin Conductance
timeFrame: baseline (Day 1), Day 8, Day 15, Day 29, Day 57, Day 85
measure: Change from Baseline in Physiological Parameters - Body Temperature
timeFrame: baseline (Day 1), Day 8, Day 15, Day 29, Day 57, Day 85
measure: Change from Baseline in Physiological Parameters - Respiratory Rate
timeFrame: baseline (Day 1), Day 8, Day 15, Day 29, Day 57, Day 85
Locations:
city: Douliu, Yunlin
country: Taiwan
facility: Department of Psychiatry, National Taiwan University Hospital Yunlin Branch
Study officials:
affiliation: Department of Psychiatry, National Taiwan University Hospital Yunlin Branch
name: Chia-Hao Ma, MD
role: PRINCIPAL_INVESTIGATOR
References: