QPS study for Schizophrenia and Autism Spectrum Disorder

Not Applicable

Recruiting

• Conditions: Schizophrenia, Autism spectrum disorder; Schizophrenia, Autism spectrum disorder, Transcranial Magnetic Stimulation, TMS, QPS; D012559,D000067877

• Registration Number: JPRN-jRCTs032220691
• Lead Sponsor: Kitahata Ryosuke

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-03-09
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

1) Patients who meet the diagnostic criteria for schizophrenia/schizoaffective disorder or autism spectrum disorder in the DSM-5
2) Patients who have provided written informed consent to participate in this study
3) Male and female patients aged 20 to 65 at the time of obtaining written informed consent
4) Patients who have been attending the hospital regularly and have not changed their psychotropic drug for the past 3 months

Exclusion Criteria

1) Patients with cerebral organic diseases (intermediate intracranial organic lesions or neurodegenerative diseases, etc.)
2) Patients with a history of seizures or epilepsy
3) Patients with a history of substance use disorders in the past 6 months
4) Patients who has received electroconvulsivetherapy in the past 6 months
5) Patients with serious or unstable physical illness
6) Patients being pregnant, breastfeeding, or hoping to become pregnant
7) Patients with alcohol allergy
8) Patients with contraindications to TMS or MRI procedures such as metal implants, pacemakers, claustrophobia, tattoos (including art makeup) larger than a single point (2 x 2 cm) on the head and neck
9) Patients whose head, neck, or body size is not suitable for MRI scanner
10) Patients who are judged to be inappropriate by the principal investigator or co-investigators

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
For patients with schizophrenia<br>Changes in PANSS score from baseline<br>Changes in BNSS score from baseline<br><br>For patients with autistic spectrum disorder:<br>Changes in RBS-R score from baseline

Secondary Outcome Measures

Name	Time	Method
Adverse events associated with TMS treatment by QPS protocol<br><br>Changes in the following items from baseline<br>For patients with schizophrenia <br> CDSS, RBANS, LNST, SNST, TMT, EXI25<br><br>For patients with autistic spectrum disorder<br> VABS2, SP