iTBS Can Increase Frontal Dopamine Release in PET Dopamine Imaging.

Not Applicable

• Conditions: Schizophrenia
• Interventions: Device: Theta burst stimulation

• Registration Number: NCT05448430
• Lead Sponsor: Central South University

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.

Study Timeline

• Status Verified: 2022-07
• Study First Submitted: 2022-07-03
• Study First Submitted QC: 2022-07-03
• Last Update Submitted: 2022-07-03
• Study First Posted: 2022-07-07
• Last Update Posted: 2022-07-07
• Study Start: 2022-07-15
• Primary Completion: 2024-07-01
• Study Completion: 2024-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

Exclusion Criteria

• drug or alcohol addiction
• diagnosed with other major mental disorders according to ICD-10 or DSM-V

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
predominant negative symptoms	Theta burst stimulation	iTBS for predominant negative symptoms

Primary Outcome Measures

Name	Time	Method
PET dopamine imaging and OGTT	immediate	PET dopamine imaging and OGTT after iTBS

Trial Locations

Locations (1)

Central South University; 🇨🇳 Changsha, Hunan, China