SchizophreniaNCT04714970
rTMS on Appetite and Cognitive Function in Schizophrenia
A study testing iTBS in people with Schizophrenia, run by Central South University at 1 site in China.
Trial summary
The weight gain and metabolic dysfunction has been vital conditions for individuals with schizophrenia. rTMS is a promising novel intervention, which have strong potentials on moderating increased appetite 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?
- iTBS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 20 Apr 2021to 1 Dec 2022
- 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 with schizophrenia in accordance with DSM-5
- Commorbid with significant weight gain after antipsychotics
- Informed Consent
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: Repetitive Transcranial Magnetic Stimulation on Appetite and Cognitive Function in Schizophrenia
The weight gain and metabolic dysfunction has been vital conditions for individuals with schizophrenia. rTMS is a promising novel intervention, which have strong potentials on moderating increased appetite 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 rTMS, using iTBS pattern, on prevention and treatment for elevated appetite and cognitive deficiency in individual with schizophrenia.
Read the detailed description
The weight gain and metabolic dysfunction has been vital conditions for individuals with schizophrenia. The cognitive function deficit has also been a major symptom for schizophrenia. However, metabolic dysfunction could further impair the cognition. rTMS is a promising novel intervention, which have strong potentials on moderating increased appetite 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 rTMS, using iTBS pattern, on prevention of the elevated appetite and cognitive deficiency in individual with schizophrenia. The intervention will last for 5 continuous days and the follow-ups are scheduled at baseline, 6days and 36days. The primary outcomes include the change of MCCB score, TFEQ score and EEG data. Secondary outcomes include the change of serum metabolic indexes and anthropometry indexes.
- Conditions
- Schizophrenia
- Being tested
- iTBS, Shame stimulation
- Keywords
- Schizophrenia, rTMS, Appetite, Cognitive Function
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iTBSDevice
Intermittent theta burst stimulation (iTBS) on left dlPFC. 90% RMT, 50Hz within train and 5Hz train for 2 second and rest for 8 second. 600 train and 200 second in total.
Shame stimulationDevice
TMS coil vertical to the brain surface, with same protocol as iTBS
| Study group | Role | What they receive |
|---|---|---|
| iTBS stimulation | Experimental | The participants randomized into experimental group will receive iTBS stimulation of dlPFC 5 times a day, with 1h interval between two stimulations, and for 5 continuous days. Receives: Device: iTBS |
| Sham stimulation | Sham comparator | The participants randomized intoSham group will receive Sham stimulation, as the coil vertical to the brain surface, 5 times a day, with 1h interval between two stimulations, and for 5 continuous days. Receives: Device: Shame stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Appetite
Three-Factor Eating Questionnaire
Measured: Change from Baseline to 6days and 36days
Change of MCCB
The MATRICS™ Consensus Cognitive Battery
Measured: Change from Baseline to 6days and 36days
Change of ERP
Food picture ERP recorded by EEG
Measured: Change from Baseline to 6days and 36days
Secondary outcomes (7)
Change of fasting glucose
in mmol/l
Measured: Change from Baseline to 6days and 36days
Change of fasting insulin level
in mmol/l
Measured: Change from Baseline to 6days and 36days
Change of Triglyceride
in mmol/l
Measured: Change from Baseline to 6days and 36days
Change of Total Cholesterol
in mmol/l
Measured: Change from Baseline to 6days and 36days
Change of LDL
in mmol/l
Measured: Change from Baseline to 6days and 36days
Change of HDL
in mmol/l
Measured: Change from Baseline to 6days and 36days
Change of BMI
weight and height will be combined to report BMI in kg/m^2
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 Jan 2021
- Study start20 Apr 2021
- Primary completion1 Nov 2022
- Study completion1 Dec 2022 (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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 60 participants are randomized, through the predetermined random number list, into intervention group or sham stimulation group in equal.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 10 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
- Investigators
- Renrong Wu, Prof, Principal investigator, Central South University Psychiatry Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04714970
- Sponsor's protocol ID
- WU2021TMS
- Status last verified
- Nov 2022
- First submitted
- 13 Jan 2021
- Last updated
- 16 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repetitive Transcranial Magnetic Stimulation on Appetite and Cognitive Function in Schizophrenia
- ClinicalTrials.gov ID
- NCT04714970
- Acronym / sponsor ID
- WU2021TMS
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, rTMS, Appetite, Cognitive Function
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Central South UniversityUniversity, hospital or other
- Collaborators
- Shanghai Mental Health Center
- Study start
- 20 Apr 2021 (actual)
- Primary completion
- 1 Nov 2022 (actual)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 20 Jan 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.
The weight gain and metabolic dysfunction has been vital conditions for individuals with schizophrenia. rTMS is a promising novel intervention, which have strong potentials on moderating increased appetite 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 rTMS, using iTBS pattern, on prevention and treatment for elevated appetite and cognitive deficiency in individual with schizophrenia.
Detailed description
The weight gain and metabolic dysfunction has been vital conditions for individuals with schizophrenia. The cognitive function deficit has also been a major symptom for schizophrenia. However, metabolic dysfunction could further impair the cognition. rTMS is a promising novel intervention, which have strong potentials on moderating increased appetite 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 rTMS, using iTBS pattern, on prevention of the elevated appetite and cognitive deficiency in individual with schizophrenia. The intervention will last for 5 continuous days and the follow-ups are scheduled at baseline, 6days and 36days. The primary outcomes include the change of MCCB score, TFEQ score and EEG data. Secondary outcomes include the change of serum metabolic indexes and anthropometry indexes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 60 participants are randomized, through the predetermined random number list, into intervention group or sham stimulation group in equal.
| Arm | Type | Receives |
|---|---|---|
| iTBS stimulation | Experimental | Device: iTBSThe participants randomized into experimental group will receive iTBS stimulation of dlPFC 5 times a day, with 1h interval between two stimulations, and for 5 continuous days. |
| Sham stimulation | Sham comparator | Device: Shame stimulationThe participants randomized intoSham group will receive Sham stimulation, as the coil vertical to the brain surface, 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 with schizophrenia in accordance with DSM-5
- Commorbid with significant weight gain after antipsychotics
- Informed Consent
Key exclusion criteria (6 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
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 |
|---|---|---|
| iTBSIntermittent theta burst stimulation (iTBS) on left dlPFC. 90% RMT, 50Hz within train and 5Hz train for 2 second and rest for 8 second. 600 train and 200 second in total. | Device | iTBS stimulation |
| Shame stimulationTMS coil vertical to the brain surface, with same protocol as iTBS | Device | Sham stimulation |
Primary outcome
Change of Appetite
Time frame: Change from Baseline to 6days and 36days
Three-Factor Eating Questionnaire
Change of MCCB
Time frame: Change from Baseline to 6days and 36days
The MATRICS™ Consensus Cognitive Battery
Change of ERP
Time frame: Change from Baseline to 6days and 36days
Food picture ERP recorded by EEG
7 secondary outcomes
Change of fasting glucose
Time frame: Change from Baseline to 6days and 36days
Change of fasting insulin level
Time frame: Change from Baseline to 6days and 36days
Change of Triglyceride
Time frame: Change from Baseline to 6days and 36days
Change of Total Cholesterol
Time frame: Change from Baseline to 6days and 36days
Change of LDL
Time frame: Change from Baseline to 6days and 36days
Change of HDL
Time frame: Change from Baseline to 6days and 36days
Change of BMI
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 16 Nov 2022.
- Individual participant dataSharing planned: No
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.
Renrong Wu, Prof principal investigator
Central South University Psychiatry Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iTBS 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 6 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 16 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?
Change of Appetite (time frame: Change from Baseline to 6days and 36days). The study lists 3 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 16 Nov 2022.