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Personalized iTBS in Real-World Clinical Settings for Schizophrenia

Study acronym: EPSREAL-SC
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated December 30, 2025 (before its estimated September 20, 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 1 to 2
    • Start date changed from estimate of Sep 20, 2025 to Oct 20, 2025
    v2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07176468
Lead Sponsor Anhui Medical University
Conditions
(from sponsor)		 Schizophrenia, Transcranial Magnetic Stimulation
Related terms Schizophrenia
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov