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Efficacy of Personalized iTBS in Real-World Clinical Settings for Alleviating Schizophrenia Symptoms : A Randomized Single-Blind Trial

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This study is designed to determine whether neuronavigation-guided, personalized Intermittent Theta-Burst Stimulation (iTBS) can produce clinically benefits for patients with schizophrenia when delivered in real-world treatment settings. By situating the intervention within real-world treatment settings-without imposing restrictions on concurrent pharmacotherapy-this trial seeks to generate evidence that is both scientifically rigorous and clinically relevant. The main questions it seeks to address are: Does the personalized iTBS target TMS protocol improve clinical symptoms in patients with schizophrenia within real-world treatment settings? What neural circuit changes, as assessed by functional MRI, occur following TMS treatment? Participants will: Undergo personalized,personalized iTBS target treatment daily for 2 weeks. Complete baseline and post-treatment assessments, including clinical symptom scales (PANSS, HAMA, HAMD) and neuropsychological tests (MoCA, DST, VFT, Stroop Test, and AVLT). Have structural and resting-state functional MRI scans before and after treatment. Be monitored for any treatment-related adverse events.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: f
View:

• Aged 18-60 years, any gender

• Meets DSM-5 criteria for schizophrenia

• Antipsychotic medication change (initiation, dose adjustment, or switch) occurred within the past 3 days

• Capable of understanding the study and providing written informed consent Able to comply with study procedures and complete assessments

Locations
Other Locations
China
Anhui Medical University
NOT_YET_RECRUITING
Hefei
Anhui Medical University
RECRUITING
Hefei
Contact Information
Primary
Kai Wang, MD
wangkai1964@126.com
0551 6516 7581
Backup
Gong-Jun Ji, PhD
jigongjun@163.com
+8618134516380
Time Frame
Start Date: 2025-10-20
Estimated Completion Date: 2026-09-20
Participants
Target number of participants: 40
Treatments
Experimental: Experimental:Neuronavigation-guided individualized intermittent theta burst stimulation (iTBS)
Participants will receive iTBS daily for 2 week within real-world treatment settings
No_intervention: Control group: ordinary drug treatment
The participants will receive regular medication treatment every day for 2 week.
Related Therapeutic Areas
Sponsors
Leads: Anhui Medical University

This content was sourced from clinicaltrials.gov