Schizophrenia Schizophrenia
Conditions
Sponsors
Kishi Taro
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. The clinical trial will be described in detail to the individuals, and written informed consent will be obtained from all participants and their guardians 2. Individuals age: 18 >= years old and < 65 years old 3. Individuals who will meet the DSM-5-TR criteria for schizophrenia (based on SCID-5-RV) 4. Individuals who will have received appropriate pharmacological treatment with antipsychotics* * The definition Individuals who will have received at least two antipsychotics with a sufficient dose (within the doses approved in Japan) for 2 weeks or more (we will confirm the result from their medical records). If individuals are receiving combination therapy with two or more of these antipsychotics, we will select the antipsychotic with the highest dose among these antipsychotics (the Defined Daily Dose (https://www.who.int/tools/atc-ddd-toolkit/about-ddd)). If there are two or more antipsychotics that used the same equivalent dose during the same period, we will select one of these antipsychotics for the evaluation of the definition. 5. Individuals who will have a CGI-S score of 4 or higher for negative symptoms at baseline 6. Individuals who will have a CGI-S score of 3 or lower for positive symptoms at baseline
Exclusion criteria
Exclusion criteria: 1. Individuals with metal implants or devices close to the stimulation site (e.g., cochlear implants, surgical clips with magnetic properties, or neurostimulators such as deep brain stimulation or vagus nerve stimulation), individuals with a cardiac pacemaker 2. Individuals with metal implants or devices not close to the stimulation site (e.g., implanted medication pumps), titanium products in their heads, magnetic dentures/implants 3. Individuals with a history of seizures, a history of intracranial lesions at risk for seizures, individuals taking drugs that reduce seizure threshold (methylphenidate or ketamine), individuals with alcohol or stimulant use disorder or withdrawal, pregnant individuals, individuals with severe physical disease 4. Individuals with a history of receiving rTMS in the current depressive episode (with a diagnosis of major depressive disorder within the past 6 months) 5. Individuals diagnosed with dementia, organic or symptomatic psychosis 6. Individuals with unimproved negative symptoms due to poor adherence to pharmacological treatment 7. Individuals diagnosed with substance or medication-induced mood disorder 8. Individuals who will answer "yes" at baseline to the following questions: "Do you have any suicidal ideations although you do not have any plans for committing suicide? or "Do you have any suicidal ideations and any plans for committing suicide?" 9. Individuals judged to be inappropriate by researchers
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in negative symptoms (change from baseline to week 4 in BPRS negative subscale score) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in overall schizophrenia symptoms (change from baseline to day 5-7, week 2, 4, and 6 in BPRS total score) 2. Change in positive symptoms (change from baseline to day 5-7, week 2, 4, and 6 in BPRS positive subscale score) 3. Change in negative symptoms (change from baseline to day 5-7, week 2, and 6 in BPRS negative subscale score) 4. Change in cognitive functions (change from baseline to week 4 in PFT score) 5. Change in depression symptoms (change from baseline to day 5-7, week 2, 4, and 6 in MADRS total score) 6. Change in extrapyramidal symptoms (change from baseline to day 5-7, week 2, 4, and 6 in DIEPSS total score) 7. Change in social functioning (change from baseline to day 5-7, week 2, 4, and 6 in PSP total score) 8. Response* rate at any week of follow-up until week 4 * The definition Participant who will achieve a 50% or greater improvement in BPRS total score from baseline to week 4 9. Change in schizophrenia severity (change from baseline to day 5-7, week 2, 4, and 6 in CGI-S score) 10. Change in treatment efficacy for schizophrenia (change from baseline to day 5-7, week 2, 4, and 6 in CGI-I score) 11. Changes in the concentrations of the following brain metabolites (NAA, Glu, Gln, Glx, Cho, mI, GABA) from baseline to week 4 (MRS will be performed at baseline and at week 4) left dorsolateral prefrontal cortex left anterior cingulate cortex 12. Changes in the gut microbiota from baseline to week 4 (16S rRNA gene amplicon sequencing will be performed at baseline and at week 4) 13. All-cause discontinuation 14. Discontinuation due to adverse events 15. Incidence of total adverse events 16. Incidence of serious adverse events 17. Mortality rate 18. Incidences of individual adverse events | — |
Contacts
Public ContactTaro Kishi
Fujita Health University Hospital
Outcome results
None listed