cTBS on First-episode Drug Naive Patients With Schizophrenia

Central South University

Status: Active, not recruiting

Conditions: Schizophrenia

Treatments: Device: transcranial magnetic stimulation; Device: sham stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT05086133

WU2021TBS

Details and patient eligibility

About

cTBS is a promising novel intervention, which have strong potentials on moderating disease syndrome, suck as verbal hallucination, and cognitive deficits in schizophrenia, as it has been proved for the treatment of depression.

Therefore, the investigators designed this randomized controlled clinical trial to evaluate the efficacy and safety of cTBS on prevention and treatment for cognitive deficiency, psychotic syndrome and metabolic side-effects in drug-naive first episode individual with schizophrenia.

Full description

cTBS is a promising novel intervention, which have strong potentials on moderating disease syndrome, suck as verbal hallucination, and cognitive deficits in schizophrenia, as it has been proved for the treatment of depression.

Therefore, the investigators designed this randomized controlled clinical trial to evaluate the efficacy and safety of cTBS on prevention and treatment for cognitive deficiency, psychotic syndrome and metabolic side-effects in drug-naive first episode individual with schizophrenia.

Enrollment: 44 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients diagnosed with schizophrenia in accordance with DSM-5
• The course of the disease less then 2 years
• Accepting antipsychotics treatment for less 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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44 participants in 2 patient groups

cTBS stimulation

Experimental group

Description:

The participants randomized into experimental group will receive cTBS stimulation of left M1 area for 5 times a day, with 1h interval between two stimulations, and for 5 continuous days.

Treatment:

Device: transcranial magnetic stimulation

Sham stimulation

Sham Comparator group

Description:

The participants randomized into experimental group will receive sham stimulation of left M1 area for 5 times a day, with 1h interval between two stimulations, and for 5 continuous days.

Treatment:

Device: sham stimulation