iTBS Can Increase Frontal Dopamine Release in PET Dopamine Imaging.

• Sponsor: Central South University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05448430
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 23.6
• Patients Per Site Per Month: 2.1

Study Details

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.

1. 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.

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia	Device: Theta burst stimulation	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 50 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: Double (Care Provider, Outcomes Assessor)
• Primary Purpose: Screening
• Official Title: iTBS Can Increase Frontal Dopamine Release and Improve Glucose Metabolism in PET Dopamine Imaging of Patients With Schizophrenia.
• Anticipated Study Start Date: Jul 15, 2022
• Anticipated Primary Completion Date: Jul 1, 2024
• Anticipated Study Completion Date: Jul 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: predominant negative symptoms iTBS for predominant negative symptoms	Device: Theta burst stimulation; a new paradigm of high frequency repetitive transcranial magnetic stimulation
No Intervention: positive symptoms
No Intervention: healthy control

Outcome Measures

Primary Outcome Measures

1. PET dopamine imaging and OGTT [immediate]

   PET dopamine imaging and OGTT after iTBS

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Central South University	Changsha	Hunan	China	410000

Sponsors and Collaborators

• Central South University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Renrong Wu, Professor, Central South University
• ClinicalTrials.gov Identifier: NCT05448430
• Other Study ID Numbers: WU2022PETTMS
• First Posted: Jul 7, 2022
• Last Update Posted: Jul 7, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Schizophrenia

Study Results

No Results Posted as of Jul 7, 2022