cTBS on First-episode Drug Naive Patients With Schizophrenia

Not Applicable

Active, not recruiting

• Conditions: Schizophrenia
• Interventions: Device: transcranial magnetic stimulation; Device: sham stimulation

• Registration Number: NCT05086133
• Lead Sponsor: Central South University

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2021-09-23
• Study First Submitted QC: 2021-10-06
• Study First Posted: 2021-10-20
• Study Start: 2021-11-20
• Status Verified: 2022-11
• Primary Completion: 2022-11-15
• Last Update Submitted: 2022-11-16
• Last Update Posted: 2022-11-17
• Study Completion: 2023-06-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 44

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
cTBS stimulation	transcranial magnetic stimulation	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.
Sham stimulation	sham stimulation	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.

Primary Outcome Measures

Name	Time	Method
The positive and negative syndrome scale	Change from Baseline to 6days and 36days	min score 30, max score 210. The higher score means more severe symptoms.
Three-Factor Eating Questionnaire	Change from Baseline to 6days and 36days	min value 21, max value 84. The higher scores mean more unhealthy eating behavior.
MCCB	Change from Baseline to 6days and 36days	The MATRICS™ Consensus Cognitive Battery
BMI	Change from Baseline to 6days and 36days	body mass index

Secondary Outcome Measures

Name	Time	Method
Total Cholesterol	Change from Baseline to 6days and 36days	in mmol/l
fasting glucose	Change from Baseline to 6days and 36days	in mmol/l
Low Density Lipoprotein	Change from Baseline to 6days and 36days	in mmol/l
Triglyceride	Change from Baseline to 6days and 36days	in mmol/l
High Density Lipoprotein	Change from Baseline to 6days and 36days	in mmol/l
Resting EEG	Change from Baseline to 6days and 36days	resting EEG (electroencephalogram) with eyes opened, eye closed and natural stimulation. The reEEG power spectra, functional connection will be calculated.

Trial Locations

Locations (1)

Central South University; 🇨🇳 Changsha, Hunan, China