cTBS on First-episode Drug Naive Patients With Schizophrenia

Schizophrenia Clinical Trial

Official title:

The Effect of cTBS on First-episode Drug Naive Patients With Schizophrenia

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05086133
• Other study ID #: WU2021TBS
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 20, 2021
• Est. completion date: June 1, 2023

Study information

• Verified date: November 2022
• Source: Central South University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 44
• Est. completion date: June 1, 2023
• Est. primary completion date: November 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Device:
• transcranial magnetic stimulation
transcranial magnetic stimulation with continuous theta burst pattern, 90% RMT, 50Hz within train and 5Hz train for 200 train and 40 second in total.
• sham stimulation
TMS coil vertical to the brain surface, with same protocol as cTBS

Locations

Country	Name	City	State
China	Central South University	Changsha	Hunan

Sponsors (2)

Lead Sponsor	Collaborator
Central South University	Shanghai Mental Health Center

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Three-Factor Eating Questionnaire	min value 21, max value 84. The higher scores mean more unhealthy eating behavior.	Change from Baseline to 6days and 36days
Primary	MCCB	The MATRICS™ Consensus Cognitive Battery	Change from Baseline to 6days and 36days
Primary	The positive and negative syndrome scale	min score 30, max score 210. The higher score means more severe symptoms.	Change from Baseline to 6days and 36days
Primary	BMI	body mass index	Change from Baseline to 6days and 36days
Secondary	Resting EEG	resting EEG (electroencephalogram) with eyes opened, eye closed and natural stimulation. The reEEG power spectra, functional connection will be calculated.	Change from Baseline to 6days and 36days
Secondary	fasting glucose	in mmol/l	Change from Baseline to 6days and 36days
Secondary	Triglyceride	in mmol/l	Change from Baseline to 6days and 36days
Secondary	Total Cholesterol	in mmol/l	Change from Baseline to 6days and 36days
Secondary	Low Density Lipoprotein	in mmol/l	Change from Baseline to 6days and 36days
Secondary	High Density Lipoprotein	in mmol/l	Change from Baseline to 6days and 36days