Back to resultscTBS on First-episode Drug Naive Patients With Schizophrenia
Primary Purpose
Schizophrenia
Status
Active
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
transcranial magnetic stimulation
sham stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia
Eligibility Criteria
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
Sites / Locations
- Central South University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
cTBS stimulation
Sham stimulation
Arm 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.
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.
Outcomes
Primary Outcome Measures
Three-Factor Eating Questionnaire
min value 21, max value 84. The higher scores mean more unhealthy eating behavior.
MCCB
The MATRICS™ Consensus Cognitive Battery
The positive and negative syndrome scale
min score 30, max score 210. The higher score means more severe symptoms.
BMI
body mass index
Secondary Outcome Measures
Resting EEG
resting EEG (electroencephalogram) with eyes opened, eye closed and natural stimulation. The reEEG power spectra, functional connection will be calculated.
fasting glucose
in mmol/l
Triglyceride
in mmol/l
Total Cholesterol
in mmol/l
Low Density Lipoprotein
in mmol/l
High Density Lipoprotein
in mmol/l
Full Information
NCT ID
NCT05086133
First Posted
September 23, 2021
Last Updated
November 16, 2022
Sponsor
Central South University
Collaborators
Shanghai Mental Health Center
1. Study Identification
Unique Protocol Identification Number
NCT05086133
Brief Title
cTBS on First-episode Drug Naive Patients With Schizophrenia
Official Title
The Effect of cTBS on First-episode Drug Naive Patients With Schizophrenia
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 20, 2021 (Actual)
Primary Completion Date
November 15, 2022 (Actual)
Study Completion Date
June 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Central South University
Collaborators
Shanghai Mental Health Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
1 group for intervention and 1 group for sham stimulation
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
The participants will be randomized into experimental group or sham group by a predetermined randomization table. The participants, care provider, investigators and outcomes assessor will be blind to the grouping. The physician who perform the TMS intervention is not blind to the grouping.
Allocation
Randomized
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
cTBS stimulation
Arm Type
Experimental
Arm 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.
Arm Title
Sham stimulation
Arm Type
Sham Comparator
Arm 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.
Intervention Type
Device
Intervention Name(s)
transcranial magnetic stimulation
Intervention Description
transcranial magnetic stimulation with continuous theta burst pattern, 90% RMT, 50Hz within train and 5Hz train for 200 train and 40 second in total.
Intervention Type
Device
Intervention Name(s)
sham stimulation
Intervention Description
TMS coil vertical to the brain surface, with same protocol as cTBS
Primary Outcome Measure Information:
Title
Three-Factor Eating Questionnaire
Description
min value 21, max value 84. The higher scores mean more unhealthy eating behavior.
Time Frame
Change from Baseline to 6days and 36days
Title
MCCB
Description
The MATRICS™ Consensus Cognitive Battery
Time Frame
Change from Baseline to 6days and 36days
Title
The positive and negative syndrome scale
Description
min score 30, max score 210. The higher score means more severe symptoms.
Time Frame
Change from Baseline to 6days and 36days
Title
BMI
Description
body mass index
Time Frame
Change from Baseline to 6days and 36days
Secondary Outcome Measure Information:
Title
Resting EEG
Description
resting EEG (electroencephalogram) with eyes opened, eye closed and natural stimulation. The reEEG power spectra, functional connection will be calculated.
Time Frame
Change from Baseline to 6days and 36days
Title
fasting glucose
Description
in mmol/l
Time Frame
Change from Baseline to 6days and 36days
Title
Triglyceride
Description
in mmol/l
Time Frame
Change from Baseline to 6days and 36days
Title
Total Cholesterol
Description
in mmol/l
Time Frame
Change from Baseline to 6days and 36days
Title
Low Density Lipoprotein
Description
in mmol/l
Time Frame
Change from Baseline to 6days and 36days
Title
High Density Lipoprotein
Description
in mmol/l
Time Frame
Change from Baseline to 6days and 36days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410000
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
cTBS on First-episode Drug Naive Patients With Schizophrenia
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