NCT05448430

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable schizophrenia

Timeline
Completed

Started Jul 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 3, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 7, 2022

Completed
8 days until next milestone

Study Start

First participant enrolled

July 15, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
Last Updated

July 7, 2022

Status Verified

July 1, 2022

Enrollment Period

2 years

First QC Date

July 3, 2022

Last Update Submit

July 3, 2022

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

  • PET dopamine imaging and OGTT

    PET dopamine imaging and OGTT after iTBS

    immediate

Study Arms (3)

predominant negative symptoms

EXPERIMENTAL

iTBS for predominant negative symptoms

Device: Theta burst stimulation

positive symptoms

NO INTERVENTION

healthy control

NO INTERVENTION

Interventions

Theta burst stimulationDEVICE

a new paradigm of high frequency repetitive transcranial magnetic stimulation

predominant negative symptoms

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • PANSS for positive symptoms of 20 or more
  • drug-naive

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Central South University

Changsha, Hunan, 410000, China

Location

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Central Study Contacts

Qiongqiong Wu, MD

CONTACT

8615084781635553733595@qq.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 3, 2022

First Posted

July 7, 2022

Study Start

July 15, 2022

Primary Completion

July 1, 2024

Study Completion

July 1, 2024

Last Updated

July 7, 2022

Record last verified: 2022-07

Locations

CN(1)