Using accelerated dTMS to help with antipsychotic-related weight gain in schizophrenia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study examines whether accelerated intermittent theta burst stimulation (ACC-iTBS) delivered via dTMS is safe and effective for reducing antipsychotic-induced weight gain. Participants with schizophrenia who have gained about 7% body weight within two years of antipsychotic treatment are randomized to active dTMS or sham, receiving three daily sessions for 10 days. Follow-ups occur at baseline, day 12, and day 42 after treatment to assess weight changes and other outcomes. The trial also aims to develop predictive models of response using radiomics and metabolomics to understand underlying mechanisms.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Aged between 18-60.
* Meeting the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnostic criteria for schizophrenia, confirmed by the Structured Clinical Interview for DSM-5 (SCID-5).
* Gaining body weight around 7% after intaking antipsychotics within 2 years.
* Participants were on a stable medication regimen at the time of enrollment. ●Written informed consent was obtained from both the participants and their legally authorized guardians.

Exclusion Criteria:

* Participants who switch antipsychotic drugs (APDs) or require a dose modification exceeding 25% of the baseline dosage during the study period.
* Diagnosed with other mental diseases in accordance with DSM-V.
* Comorbid with other severe physiological diseases.
* Active suicidal ideation.
* A history of alcohol or substance use disorder (or abuse).
* Presence of metal implants or any other conditions contraindicated for magnetic resonance imaging (MRI).
* Presence of intracranial metal or electronic devices, a personal or family history of epilepsy, or any other standard contraindications to deep transcranial magnetic stimulation.
* Receipt of regular transcranial magnetic stimulation (TMS), electroconvulsive therapy (ECT), or weight-loss interventions within the past month.
* Pregnant or lactating women

Where it's running

• The Second Xiangya Hospital of Central South University
  Changsha, Hunan, China Recruiting

Study contacts

• Study coordinator: Ping Shao
• Email: shp97jw@163.com
• Phone: +86-13755112445

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.