SchizophreniaNCT05086133
cTBS on First-episode Drug Naive Patients With Schizophrenia
A study testing transcranial magnetic stimulation in people with Schizophrenia, run by Central South University at 1 site in China.
Trial summary
cTBS is a promising novel intervention, which have strong potentials on moderating disease syndrome, suck as verbal hallucination, and cognitive deficits in schizophrenia, as it has been proved for the treatment of depression. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- transcranial magnetic stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteChina
- Study dates
- 20 Nov 2021to 1 Jun 2023
- 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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients diagnosed with schizophrenia in accordance with DSM-5
- The course of the disease less then 2 years
- Accepting antipsychotics treatment for less then 2 months
Who cannot join
- Diagnosed with other mental disease in accordance with DSM-5
- Comorbid with other severe physiological disease
- Used antipsychotic, antidepressants, mood stabilizer, or other psychoactive substances before
- Drug or alcohol abuse
- Pregnant or lactating Contraindication to rTMS
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of cTBS on First-episode Drug Naive Patients With Schizophrenia
cTBS is a promising novel intervention, which have strong potentials on moderating disease syndrome, suck as verbal hallucination, and cognitive deficits in schizophrenia, as it has been proved for the treatment of depression.
Therefore, the investigators designed this randomized controlled clinical trial to evaluate the efficacy and safety of cTBS on prevention and treatment for cognitive deficiency, psychotic syndrome and metabolic side-effects in drug-naive first episode individual with schizophrenia.
Read the detailed description
cTBS is a promising novel intervention, which have strong potentials on moderating disease syndrome, suck as verbal hallucination, and cognitive deficits in schizophrenia, as it has been proved for the treatment of depression.
Therefore, the investigators designed this randomized controlled clinical trial to evaluate the efficacy and safety of cTBS on prevention and treatment for cognitive deficiency, psychotic syndrome and metabolic side-effects in drug-naive first episode individual with schizophrenia.
- Conditions
- Schizophrenia
- Being tested
- transcranial magnetic stimulation, sham stimulation
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial magnetic stimulationDevice
transcranial magnetic stimulation with continuous theta burst pattern, 90% RMT, 50Hz within train and 5Hz train for 200 train and 40 second in total.
sham stimulationDevice
TMS coil vertical to the brain surface, with same protocol as cTBS
| Study group | Role | What they receive |
|---|---|---|
| cTBS stimulation | Experimental | The participants randomized into experimental group will receive cTBS stimulation of left M1 area for 5 times a day, with 1h interval between two stimulations, and for 5 continuous days. Receives: Device: transcranial magnetic stimulation |
| Sham stimulation | Sham comparator | The participants randomized into experimental group will receive sham stimulation of left M1 area for 5 times a day, with 1h interval between two stimulations, and for 5 continuous days. Receives: Device: sham stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Three-Factor Eating Questionnaire
min value 21, max value 84. The higher scores mean more unhealthy eating behavior.
Measured: Change from Baseline to 6days and 36days
MCCB
The MATRICS™ Consensus Cognitive Battery
Measured: Change from Baseline to 6days and 36days
The positive and negative syndrome scale
min score 30, max score 210. The higher score means more severe symptoms.
Measured: Change from Baseline to 6days and 36days
BMI
body mass index
Measured: Change from Baseline to 6days and 36days
Secondary outcomes (6)
Resting EEG
resting EEG (electroencephalogram) with eyes opened, eye closed and natural stimulation. The reEEG power spectra, functional connection will be calculated.
Measured: Change from Baseline to 6days and 36days
fasting glucose
in mmol/l
Measured: Change from Baseline to 6days and 36days
Triglyceride
in mmol/l
Measured: Change from Baseline to 6days and 36days
Total Cholesterol
in mmol/l
Measured: Change from Baseline to 6days and 36days
Low Density Lipoprotein
in mmol/l
Measured: Change from Baseline to 6days and 36days
High Density Lipoprotein
in mmol/l
Measured: Change from Baseline to 6days and 36days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2021
- Study start20 Nov 2021
- Primary completion15 Nov 2022
- Study completion1 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1 group for intervention and 1 group for sham stimulation
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central South University
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Mental Health Center
- Responsible party
- Principal investigator, Renrong Wu, Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05086133
- Sponsor's protocol ID
- WU2021TBS
- Status last verified
- Nov 2022
- First submitted
- 23 Sep 2021
- Last updated
- 17 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kang D, Song C, Peng X, Yu G, Yang Y, Chen C, Long Y, Shao P, Wu R. The effect of continuous theta burst stimulation on antipsychotic-induced weight gain in first-episode drug-naive individuals with schizophrenia: a double-blind, randomized, sham-controlled feasibility trial. Transl Psychiatry. 2024 Jan 25;14(1):61. doi: 10.1038/s41398-024-02770-w.
PubMed 38272892Kang D, Zhang Y, Wu G, Song C, Peng X, Long Y, Yu G, Tang H, Gui Y, Wang Q, Yuan T, Wu R. The Effect of Accelerated Continuous Theta Burst Stimulation on Weight Loss in Overweight Individuals With Schizophrenia: A Double-Blind, Randomized, Sham-Controlled Clinical Trial. Schizophr Bull. 2024 Apr 30;50(3):589-599. doi: 10.1093/schbul/sbad144.
PubMed 37921353
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of cTBS on First-episode Drug Naive Patients With Schizophrenia
- ClinicalTrials.gov ID
- NCT05086133
- Acronym / sponsor ID
- WU2021TBS
- Conditions
- Schizophrenia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Central South UniversityUniversity, hospital or other
- Collaborators
- Shanghai Mental Health Center
- Study start
- 20 Nov 2021 (actual)
- Primary completion
- 15 Nov 2022 (actual)
- Study completion
- 1 Jun 2023 (estimated)
- First posted
- 20 Oct 2021 (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.
cTBS is a promising novel intervention, which have strong potentials on moderating disease syndrome, suck as verbal hallucination, and cognitive deficits in schizophrenia, as it has been proved for the treatment of depression.
Therefore, the investigators designed this randomized controlled clinical trial to evaluate the efficacy and safety of cTBS on prevention and treatment for cognitive deficiency, psychotic syndrome and metabolic side-effects in drug-naive first episode individual with schizophrenia.
Detailed description
cTBS is a promising novel intervention, which have strong potentials on moderating disease syndrome, suck as verbal hallucination, and cognitive deficits in schizophrenia, as it has been proved for the treatment of depression.
Therefore, the investigators designed this randomized controlled clinical trial to evaluate the efficacy and safety of cTBS on prevention and treatment for cognitive deficiency, psychotic syndrome and metabolic side-effects in drug-naive first episode individual with schizophrenia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 1 group for intervention and 1 group for sham stimulation
| Arm | Type | Receives |
|---|---|---|
| cTBS stimulation | Experimental | Device: transcranial magnetic stimulationThe participants randomized into experimental group will receive cTBS stimulation of left M1 area for 5 times a day, with 1h interval between two stimulations, and for 5 continuous days. |
| Sham stimulation | Sham comparator | Device: sham stimulationThe participants randomized into experimental group will receive sham stimulation of left M1 area for 5 times a day, with 1h interval between two stimulations, and for 5 continuous days. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients diagnosed with schizophrenia in accordance with DSM-5
- The course of the disease less then 2 years
- Accepting antipsychotics treatment for less then 2 months
Key exclusion criteria (5 listed)
- Diagnosed with other mental disease in accordance with DSM-5
- Comorbid with other severe physiological disease
- Used antipsychotic, antidepressants, mood stabilizer, or other psychoactive substances before
- Drug or alcohol abuse
- Pregnant or lactating Contraindication to rTMS
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 |
|---|---|---|
| transcranial magnetic stimulationtranscranial magnetic stimulation with continuous theta burst pattern, 90% RMT, 50Hz within train and 5Hz train for 200 train and 40 second in total. | Device | cTBS stimulation |
| sham stimulationTMS coil vertical to the brain surface, with same protocol as cTBS | Device | Sham stimulation |
Primary outcome
Three-Factor Eating Questionnaire
Time frame: Change from Baseline to 6days and 36days
min value 21, max value 84. The higher scores mean more unhealthy eating behavior.
MCCB
Time frame: Change from Baseline to 6days and 36days
The MATRICS™ Consensus Cognitive Battery
The positive and negative syndrome scale
Time frame: Change from Baseline to 6days and 36days
min score 30, max score 210. The higher score means more severe symptoms.
BMI
Time frame: Change from Baseline to 6days and 36days
body mass index
6 secondary outcomes
Resting EEG
Time frame: Change from Baseline to 6days and 36days
fasting glucose
Time frame: Change from Baseline to 6days and 36days
Triglyceride
Time frame: Change from Baseline to 6days and 36days
Total Cholesterol
Time frame: Change from Baseline to 6days and 36days
Low Density Lipoprotein
Time frame: Change from Baseline to 6days and 36days
High Density Lipoprotein
Time frame: Change from Baseline to 6days and 36days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2022.
- Derived from this study: PubMed 38272892Kang D, Song C, Peng X, Yu G, Yang Y, Chen C, Long Y, Shao P, Wu R. The effect of continuous theta burst stimulation on antipsychotic-induced weight gain in first-episode drug-naive individuals with schizophrenia: a double-blind, randomized, sham-controlled feasibility trial. Transl Psychiatry. 2024 Jan 25;14(1):61. doi: 10.1038/s41398-024-02770-w.
- Derived from this study: PubMed 37921353Kang D, Zhang Y, Wu G, Song C, Peng X, Long Y, Yu G, Tang H, Gui Y, Wang Q, Yuan T, Wu R. The Effect of Accelerated Continuous Theta Burst Stimulation on Weight Loss in Overweight Individuals With Schizophrenia: A Double-Blind, Randomized, Sham-Controlled Clinical Trial. Schizophr Bull. 2024 Apr 30;50(3):589-599. doi: 10.1093/schbul/sbad144.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcranial magnetic 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 3 inclusion and 5 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 17 Nov 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. Some participants in this study may receive a placebo. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Three-Factor Eating Questionnaire (time frame: Change from Baseline to 6days and 36days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05086133, which also lists 2 linked publications.
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 17 Nov 2022.