Back to resultsiTBS Can Increase Frontal Dopamine Release in PET Dopamine Imaging.
Primary Purpose
Schizophrenia
Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Theta burst stimulation
Sponsored by
About this trial
This is an interventional screening trial for Schizophrenia
Eligibility Criteria
Inclusion Criteria for negative group
- diagnosed with schizophrenia according to ICD-10 or DSM-V
- Positive and Negative Syndrome Scale factor score for negative symptoms of 24 or moreand score of 4 or more on at least two of three core negative PANSS items
- PANSS for positive symptoms of 19 or less, and HAMD depression scale of 16 or less.
- drug-naive Inclusion Criteria for positive group
- PANSS for positive symptoms of 20 or more
- drug-naive
Exclusion Criteria:
- drug or alcohol addiction
- diagnosed with other major mental disorders according to ICD-10 or DSM-V
Sites / Locations
- Central South University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
No Intervention
No Intervention
Arm Label
predominant negative symptoms
positive symptoms
healthy control
Arm Description
iTBS for predominant negative symptoms
Outcomes
Primary Outcome Measures
PET dopamine imaging and OGTT
PET dopamine imaging and OGTT after iTBS
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05448430
Brief Title
iTBS Can Increase Frontal Dopamine Release in PET Dopamine Imaging.
Official Title
iTBS Can Increase Frontal Dopamine Release and Improve Glucose Metabolism in PET Dopamine Imaging of Patients With Schizophrenia.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 15, 2022 (Anticipated)
Primary Completion Date
July 1, 2024 (Anticipated)
Study Completion Date
July 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Central South University
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
Aim: 1. To confirm that patients with predominant negative symptoms in schizophrenia have deficits in frontal cortical dopamine release when compared with healthy control and patients with positive symptoms.
2. Our previous study found patients with negative symptoms have more possibilities to have disorders in glucose metabolism, we wonder whether dopamine release, negative symptoms or glucose metabolism can be improved by iTBS.
Study design: Case control study.
Detailed Description
Eligibility Criteria: Predominant negative symptoms for Positive and Negative Syndrome Scale factor score for negative symptoms of 24 or more, and score of 4 or more on at least two of three core negative PANSS items, PANSS for positive symptoms of 19 or less, HAMD depression scale of 16 or less. Predominant positive symptoms for PANSS for positive symptoms of 20 or more. Healthy control will be recruited matching the age and sex of patient groups, Outcome Measures: Oral glucose tolerance test (OGTT), PET dopamine imaging.
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
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Non-Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
predominant negative symptoms
Arm Type
Experimental
Arm Description
iTBS for predominant negative symptoms
Arm Title
positive symptoms
Arm Type
No Intervention
Arm Title
healthy control
Arm Type
No Intervention
Intervention Type
Device
Intervention Name(s)
Theta burst stimulation
Intervention Description
a new paradigm of high frequency repetitive transcranial magnetic stimulation
Primary Outcome Measure Information:
Title
PET dopamine imaging and OGTT
Description
PET dopamine imaging and OGTT after iTBS
Time Frame
immediate
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria for negative group
diagnosed with schizophrenia according to ICD-10 or DSM-V
Positive and Negative Syndrome Scale factor score for negative symptoms of 24 or moreand score of 4 or more on at least two of three core negative PANSS items
PANSS for positive symptoms of 19 or less, and HAMD depression scale of 16 or less.
drug-naive Inclusion Criteria for positive group
PANSS for positive symptoms of 20 or more
drug-naive
Exclusion Criteria:
drug or alcohol addiction
diagnosed with other major mental disorders according to ICD-10 or DSM-V
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qiongqiong Wu, MD
Phone
8615084781635
Email
553733595@qq.com
Facility Information:
Facility Name
Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410000
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Renrong Wu, Prof
Phone
+86 158 741 79855
Email
wurenrong@csu.edu
First Name & Middle Initial & Last Name & Degree
Renrong Wu, Prof
First Name & Middle Initial & Last Name & Degree
Qiongqiong Wu, M.D.
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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iTBS Can Increase Frontal Dopamine Release in PET Dopamine Imaging.
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