cTBS on First-episode Drug Naive Patients With Schizophrenia

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

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 Overview

• Status: Active, not recruiting
• Conditions: Schizophrenia
• Intervention / Treatment: Device: transcranial magnetic stimulation; Device: sham stimulation

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 Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hunan
    • Changsha, Hunan, China, 410000
      • Central South University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: cTBS 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.	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 Comparator: 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.	Device: sham stimulation; TMS coil vertical to the brain surface, with same protocol as cTBS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
MCCB	The MATRICS™ Consensus Cognitive Battery	Change from Baseline to 6days and 36days
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
BMI	body mass index	Change from Baseline to 6days and 36days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
fasting glucose	in mmol/l	Change from Baseline to 6days and 36days
Triglyceride	in mmol/l	Change from Baseline to 6days and 36days
Total Cholesterol	in mmol/l	Change from Baseline to 6days and 36days
Low Density Lipoprotein	in mmol/l	Change from Baseline to 6days and 36days
High Density Lipoprotein	in mmol/l	Change from Baseline to 6days and 36days

Collaborators and Investigators

• Sponsor: Central South University
• Collaborators: Shanghai Mental Health Center

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2021
• Primary Completion (Actual): November 15, 2022
• Study Completion (Anticipated): June 1, 2023

Study Registration Dates

• First Submitted: September 23, 2021
• First Submitted That Met QC Criteria: October 6, 2021
• First Posted (Actual): October 20, 2021

Study Record Updates

• Last Update Posted (Actual): November 17, 2022
• Last Update Submitted That Met QC Criteria: November 16, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia
• Other Study ID Numbers: WU2021TBS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No