SchizophreniaNCT05358899
Accelerated cTBS on Metabolic Dysfunction in People With Schizophrenia
A study testing accelerated theta burst stimulation in people with Schizophrenia and Metabolic Disturbance, run by Central South University at 1 site in China.
Trial summary
cTBS is a promising novel intervention, which has strong potential on moderating disease syndrome. However, the most effective pattern of the cTBS is still under debate. Therefore, the investigators designed this randomized controlled clinical trial to evaluate the efficacy and safety of accelerated cTBS, with 1800… Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Schizophrenia, Metabolic Disturbance, Eating Behavior
- What is being tested?
- accelerated theta burst stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2022to 1 May 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
- BMI over 24
- Accepting antipsychotics stable treatment for more 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.
China1 site, 1 recruiting
- Recruiting
Second Xiangya Hospital Central South University
Changsha, Hunan, 410000
Dongyu Kang, MD, +86 13787142461, kangdongyu@csu.edu.cn
About this study
Official title: The Effect and Safety of Accelerated Continuous Theta-burst Stimulation on Metabolic Dysfunction in People With Schizophrenia
cTBS is a promising novel intervention, which has strong potential on moderating disease syndrome. However, the most effective pattern of the cTBS is still under debate. Therefore, the investigators designed this randomized controlled clinical trial to evaluate the efficacy and safety of accelerated cTBS, with 1800 stimulation per session, on intervention to metabolic side effects in individuals with schizophrenia.
- Being tested
- accelerated theta burst stimulation, Sham stimulation
- Keywords
- schizophrenia, metabolic disturbance, cTBS, Event related potentials
- Medical subject headings
- Schizophrenia, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
accelerated theta burst stimulationDevice
cTBS was administered at 80% of each participant's M1 area in a burst-firing pattern (3 pulses at 50 Hz) with a repetition frequency of 5 Hz (200 ms intervals). During each session, participants received 1800 pulses (120 s).
Sham stimulationDevice
Similar process with the accelerated theta burst stimulation with the coil 90 degrees tilted to the surface of the scalp, which could produce identical sound and vibration while avoiding real magnetic stimulation.
| Study group | Role | What they receive |
|---|---|---|
| Real stimulation | Experimental | Participants in the real stimulation group will receive accelerated cTBS with 1800 stimulation per session for 10 consecutive days, 5 sessions per day with a gap at least one hour, 50 sessions in total. The stimulation will be conducted at left M1 area. Receives: Device: accelerated theta burst stimulation |
| Sham stimulation | Sham comparator | Participants in the sham stimulation group will receive the stimulation with coil vertical to the surface with other settings same as the real stimulation group. Receives: Device: Sham stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of body weight
the change of participants weight
Measured: from baseline to 6 weeks
Change of body mass index
the change of participants BMI
Measured: from baseline to 6 weeks
Secondary outcomes (5)
Positive and Negative syndrome rating scale
Positive and Negative syndrome rating scale, from 30-210, higher score means worse symptoms.
Measured: from baseline to 6 weeks
Three Factor Eating Questionnaire
three domain regarding eating behavior, from 0-51, higher score means better.
Measured: from baseline to 6 weeks
Barrat impulsiveness scale
four domains regarding impulsiveness, from 26-104 higher score means higher impulse.
Measured: from baseline to 6 weeks
Self-Control Scale
five domains regarding self control ability, from 36-180 higher score means better self control.
Measured: from baseline to 6 weeks
Food picture stimulation Event-related potentials
Several components of event-related potentials were analyzed regarding various cognitive processes. The data were analyzed using previously widely used pipelines to extract the characters of ERP components, for example, P3 and LPP, and compare its difference within groups and between groups through time. ERP analysis will be conducted using EEGLAB and FieldTrip in MATLAB, and statistic analysis will be conducted using R studio and SPSS.
Measured: from baseline to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2022
- Study start1 Jun 2022
- Primary completion1 Dec 2022 (estimated)
- Study completion1 May 2023 (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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Quadro-blind clinical trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 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
- NCT05358899
- Sponsor's protocol ID
- wu2022acTBS
- Status last verified
- Nov 2022
- First submitted
- 28 Apr 2022
- Last updated
- 21 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The data will be provided for scientific study only with the permission of the principle investigator.
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect and Safety of Accelerated Continuous Theta-burst Stimulation on Metabolic Dysfunction in People With Schizophrenia
- ClinicalTrials.gov ID
- NCT05358899
- Acronym / sponsor ID
- wu2022acTBS
- Keywords
- schizophrenia, metabolic disturbance, cTBS, Event related potentials
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Central South UniversityUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 May 2023 (estimated)
- First posted
- 3 May 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.
cTBS is a promising novel intervention, which has strong potential on moderating disease syndrome. However, the most effective pattern of the cTBS is still under debate. Therefore, the investigators designed this randomized controlled clinical trial to evaluate the efficacy and safety of accelerated cTBS, with 1800 stimulation per session, on intervention to metabolic side effects in individuals 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
- Randomized Quadro-blind clinical trial
| Arm | Type | Receives |
|---|---|---|
| Real stimulation | Experimental | Device: accelerated theta burst stimulationParticipants in the real stimulation group will receive accelerated cTBS with 1800 stimulation per session for 10 consecutive days, 5 sessions per day with a gap at least one hour, 50 sessions in total. The stimulation will be conducted at left M1 area. |
| Sham stimulation | Sham comparator | Device: Sham stimulationParticipants in the sham stimulation group will receive the stimulation with coil vertical to the surface with other settings same as the real stimulation group. |
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
- BMI over 24
- Accepting antipsychotics stable treatment for more 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 |
|---|---|---|
| accelerated theta burst stimulationcTBS was administered at 80% of each participant's M1 area in a burst-firing pattern (3 pulses at 50 Hz) with a repetition frequency of 5 Hz (200 ms intervals). During each session, participants received 1800 pulses (120 s). | Device | Real stimulation |
| Sham stimulationSimilar process with the accelerated theta burst stimulation with the coil 90 degrees tilted to the surface of the scalp, which could produce identical sound and vibration while avoiding real magnetic stimulation. | Device | Sham stimulation |
Primary outcome
Change of body weight
Time frame: from baseline to 6 weeks
the change of participants weight
Change of body mass index
Time frame: from baseline to 6 weeks
the change of participants BMI
5 secondary outcomes
Positive and Negative syndrome rating scale
Time frame: from baseline to 6 weeks
Three Factor Eating Questionnaire
Time frame: from baseline to 6 weeks
Barrat impulsiveness scale
Time frame: from baseline to 6 weeks
Self-Control Scale
Time frame: from baseline to 6 weeks
Food picture stimulation Event-related potentials
Time frame: from baseline to 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2022.
- Individual participant dataSharing planned: Undecided. The data will be provided for scientific study only with the permission of the principle investigator.
Related trials for Schizophrenia
RecruitingPhase 1
A Study of the Feasibility, Safety and Tolerability of Aticaprant as Adjunctive Treatment in Participants With Schizophrenia
Schizophrenia
Not yet recruiting
NEURO-COGS: Neurometabolic Mechanisms of Cognitive Training in Schizophrenia
Schizophrenia, Schizoaffective Disorder
Active, not recruiting
The Acupuncture Treatment Effect in Patients With Schizophrenia
Mental Health
RecruitingPhase 2
A Study to Assess the Efficacy and Safety of ITI-1284 in the Treatment of Psychosis Associated With Alzheimer's Disease
Psychotic Disorders, Alzheimer Disease
Not yet recruitingObservational study
Real-World Impact of TV-44749 in Adults With Schizophrenia
Schizophrenia
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 accelerated theta burst stimulation in people with Schizophrenia and Metabolic Disturbance, 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 21 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?
Contact Renrong Wu, Prof (15874179855, wurenrong@csu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of body weight (time frame: from baseline to 6 weeks). The study lists 2 primary outcomes in all. 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 21 Nov 2022.