Accelerated cTBS on Metabolic Dysfunction in People With Schizophrenia

Central South University

Status: Enrolling

Conditions: Schizophrenia; Eating Behavior; Transcranial Magnetic Stimulation; Metabolic Disturbance

Treatments: Device: accelerated theta burst stimulation; Device: Sham stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT05358899

wu2022acTBS

Details and patient eligibility

About

cTBS is a promising novel intervention, which has strong potential on moderating disease syndrome. However, the most effective pattern of the cTBS is still under debate. Therefore, the investigators designed this randomized controlled clinical trial to evaluate the efficacy and safety of accelerated cTBS, with 1800 stimulation per session, on intervention to metabolic side effects in individuals with schizophrenia.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients diagnosed with schizophrenia in accordance with DSM-5
• BMI over 24
• Accepting antipsychotics stable treatment for more then 2 months

Exclusion criteria

• Diagnosed with other mental disease in accordance with DSM-5
• Comorbid with other severe physiological disease
• Used antipsychotic, antidepressants, mood stabilizer, or other psychoactive substances before
• Drug or alcohol abuse
• Pregnant or lactating Contraindication to rTMS

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups

Real stimulation

Experimental group

Description:

Participants in the real stimulation group will receive accelerated cTBS with 1800 stimulation per session for 10 consecutive days, 5 sessions per day with a gap at least one hour, 50 sessions in total. The stimulation will be conducted at left M1 area.

Treatment:

Device: accelerated theta burst stimulation

Sham stimulation

Sham Comparator group

Description:

Participants in the sham stimulation group will receive the stimulation with coil vertical to the surface with other settings same as the real stimulation group.

Treatment:

Device: Sham stimulation