iTBS Can Increase Frontal Dopamine Release in PET Dopamine Imaging.

Schizophrenia Clinical Trial

Official title:

iTBS Can Increase Frontal Dopamine Release and Improve Glucose Metabolism in PET Dopamine Imaging of Patients With Schizophrenia.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05448430
• Other study ID #: WU2022PETTMS
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 15, 2022
• Est. completion date: July 1, 2024

Study information

• Verified date: July 2022
• Source: Central South University
• Contact: Qiongqiong Wu, MD
• Phone: 8615084781635
• Email: 553733595[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: July 1, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Device:
• Theta burst stimulation
a new paradigm of high frequency repetitive transcranial magnetic stimulation

Locations

Country	Name	City	State
China	Central South University	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Central South University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PET dopamine imaging and OGTT	PET dopamine imaging and OGTT after iTBS	immediate