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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 20
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Taiwan
Department of Psychiatry, National Taiwan University Hospital Yunlin Branch
RECRUITING
Douliu, Yunlin
Contact Information
Primary
Chia-Hao Ma, MD
chiahaoma.tw@gmail.com
+886-5-5323911
Time Frame
Start Date: 2022-12-01
Estimated Completion Date: 2025-12
Participants
Target number of participants: 180
Treatments
Experimental: conventional rTMS
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
Experimental: iTBS
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
Sham_comparator: sham rTMS
target: left DLPFC~sham probe, the same protocol as active conventional rTMS
Sham_comparator: sham iTBS
target: left DLPFC~sham probe, the same protocol as active iTBS
Related Therapeutic Areas
Sponsors
Leads: National Taiwan University Hospital

This content was sourced from clinicaltrials.gov