Using brain stimulation to treat early psychosis

Repetitive Transcranial Magnetic Stimulation in Subjects With Early Psychosis and The Functional Connectivity Biotypes

This study is testing if a special brain stimulation treatment can help people with early psychosis feel better by targeting their specific symptoms and brain functions.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 300 (estimated)
• Ages: 14 Years to 45 Years
• Sex: All
• Sponsor: Shanghai Jiao Tong University School of Medicine (Academic / other)
• Locations: 6 sites (Guangzhou, Guangdong and 5 other locations)
• Trial ID: NCT04853485 on ClinicalTrials.gov

What this trial studies

This study explores the use of repetitive transcranial magnetic stimulation (rTMS) to target different brain areas in individuals experiencing early psychosis, including those at clinical high risk and those in their first episode. The approach aims to optimize treatment by tailoring rTMS protocols based on patients' specific symptoms and cognitive deficits. Participants will undergo MRI scans to assess brain functional connectivity, which will be correlated with the efficacy of the rTMS treatment. The goal is to improve outcomes for patients who often do not respond well to traditional antipsychotic medications.

Who should consider this trial

Good fit: Ideal candidates for this study are individuals aged 14-45 who are at clinical high risk for psychosis or have recently experienced their first episode of schizophrenia.

Not a fit: Patients with contraindications to TMS or MRI, those with substance abuse issues, or individuals with neurological disorders may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a more effective treatment option for patients with early psychosis, potentially improving their long-term outcomes.

How similar studies have performed: Previous studies have shown promising results for rTMS in treating negative symptoms of schizophrenia, but this specific approach targeting early psychosis is relatively novel.

Eligibility criteria

For subjects at clinical high-risk for psychosis

Inclusion Criteria:

* Meeting the syndrome of clinical high risk of psychosis, identified by a face-to-face interview using the Chinese version of Structured Interview for Prodromal Syndromes / Scale of Prodromal Symptoms (SIPS/SOPS);
* Given the written consent for participation.
* Age between 14-45 years old;
* IQ\>69;
* PANSS total scores \>= 55 or BVMT-R score \<= 26;

Exclusion Criteria:

* any contraindication to TMS treatment or magnetic resonance imaging (MRI)
* substance or alcohol abuse within recent three months
* any sensorimotor disorder (e.g., hearing disorder, lose one's sight), or any neurological disease (brain injury, epilepsy ) or any other physical disease which may lead to psychotic symptoms.

For subjects with first-episode schizophrenia

Inclusion Criteria:

* Meeting the DSM-V diagnostic criteria for schizophrenia spectrum disorders;
* Given the written consent for participation.
* Age between 14-45 years old;
* IQ\>69;
* during the first episode without a full remission;
* PANSS total scores \>= 55 or BVMT-R score \<= 26;
* within receiving rTMS, patients can receive second-generation antipsychotics except clozapine with stable dosages

Exclusion Criteria:

* any contraindication to TMS treatment or magnetic resonance imaging (MRI)
* substance or alcohol abuse within recent three months
* any sensorimotor disorder (e.g., hearing disorder, lose one's sight), or any neurological disease (brain injury, epilepsy) or any other physical disease which may lead to psychotic symptoms.

Where this trial is running

Guangzhou, Guangdong and 5 other locations

• The Affiliated Brain Hospital of Guangzhou Medical University — Guangzhou, Guangdong, China (Not_yet_recruiting)
• Nantong Fourth People's Hospital & Nantong Brain Hospital — Nantong, Jiang Su, China (Recruiting)
• Suzhou Guangji Hospital — Suzhou, Jiangsu, China (Recruiting)
• Shanghai Mental Health Center — Shanghai, Shanghai, China (Recruiting)
• Shenzhen Kangning Hospital — Shenzhen, China (Recruiting)
• Tianjin Anding Hospital — Tianjin, China (Recruiting)

Study contacts

• Principal investigator: Jijun Wang, M.D., Ph.D — Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine
• Study coordinator: Jijun Wang, M.D, Ph.D

Conditions Schizophrenia; Psychosis; First Episode Psychosis; Clinical High Risk; schizophrenia; prodromal phase; biotypes; target optimizing