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iTBS Can Increase Frontal Dopamine Release in PET Dopamine Imaging.

C

Central South University

Status

Not yet enrolling

Conditions

Schizophrenia

Treatments

Device: Theta burst stimulation

Study type

Interventional

Funder types

Other

Identifiers

NCT05448430
WU2022PETTMS

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Screening

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

Double Blind

50 participants in 3 patient groups

predominant negative symptoms
Experimental group
Description:
iTBS for predominant negative symptoms
Treatment:
Device: Theta burst stimulation
positive symptoms
No Intervention group
healthy control
No Intervention group

Trial contacts and locations

1

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Central trial contact

Qiongqiong Wu, MD

Data sourced from clinicaltrials.gov

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