SchizophreniaNCT05448430
iTBS Can Increase Frontal Dopamine Release in PET Dopamine Imaging.
A study testing Theta burst stimulation in people with Schizophrenia, run by Central South University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Theta burst stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 15 Jul 2022to 1 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- drug or alcohol addiction
- diagnosed with other major mental disorders according to ICD-10 or DSM-V
Trial locations and contacts
1 site in 1 country.
China1 site
Central South University
Changsha, Hunan, 410000
Renrong Wu, Prof, +86 158 741 79855, wurenrong@csu.edu
Renrong Wu, Prof
About this study
Official title: iTBS Can Increase Frontal Dopamine Release and Improve Glucose Metabolism in PET Dopamine Imaging of Patients With Schizophrenia.
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.
- 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.
Read the 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.
- Conditions
- Schizophrenia
- Being tested
- Theta burst stimulation
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Theta burst stimulationDevice
a new paradigm of high frequency repetitive transcranial magnetic stimulation
| Study group | Role | What they receive |
|---|---|---|
| predominant negative symptoms | Experimental | iTBS for predominant negative symptoms Receives: Device: Theta burst stimulation |
| positive symptoms | No intervention | Not described |
| healthy control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
PET dopamine imaging and OGTT
PET dopamine imaging and OGTT after iTBS
Measured: immediate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2022
- Study start15 Jul 2022 (estimated)
- Primary completion1 Jul 2024 (estimated)
- Study completion1 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Renrong Wu, Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05448430
- Sponsor's protocol ID
- WU2022PETTMS
- Status last verified
- Jul 2022
- First submitted
- 3 Jul 2022
- Last updated
- 7 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- iTBS Can Increase Frontal Dopamine Release and Improve Glucose Metabolism in PET Dopamine Imaging of Patients With Schizophrenia.
- ClinicalTrials.gov ID
- NCT05448430
- Acronym / sponsor ID
- WU2022PETTMS
- Conditions
- Schizophrenia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Central South UniversityUniversity, hospital or other
- Study start
- 15 Jul 2022 (estimated)
- Primary completion
- 1 Jul 2024 (estimated)
- Study completion
- 1 Jul 2024 (estimated)
- First posted
- 7 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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 design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| predominant negative symptoms | Experimental | Device: Theta burst stimulationiTBS for predominant negative symptoms |
| positive symptoms | No intervention | – |
| healthy control | No intervention | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- drug or alcohol addiction
- diagnosed with other major mental disorders according to ICD-10 or DSM-V
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Theta burst stimulationa new paradigm of high frequency repetitive transcranial magnetic stimulation | Device | predominant negative symptoms |
Primary outcome
PET dopamine imaging and OGTT
Time frame: immediate
PET dopamine imaging and OGTT after iTBS
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Theta burst stimulation in people with Schizophrenia, run by Central South University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qiongqiong Wu, MD (8615084781635, 553733595@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PET dopamine imaging and OGTT (time frame: immediate). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2022.