SchizophreniaNCT05783063
iTBS for Increased Appetite Induced by Antipsychotics
A study testing Active iTBS in people with Schizophrenia, run by Central South University at 2 sites in China.
Trial summary
Antipsychotics are prone to cause metabolic side effects, including weight gain, hyperglycemia, insulin resistance, hyperlipidemia and so on, leading to a 2-3 times higher risk of death in patients with schizophrenia compared to healthy people. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Active iTBS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 2 sitesChina
- Study dates
- 1 Aug 2023to 1 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Age between 18-40 years old;
- Meeting the diagnostic criteria for schizophrenia in DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition);
- BMI ≥ 25kg/m 2 or over 10% weight gain after taking antipsychotics in the last year;
- Not receiving TMS therapy in the past month;
- Using no more than two antipsychotic medications (including olanzapine, haloperidol, amisulpride, asenapine, risperidone, paliperidone, clozapine, quetiapine, iloperidone, chlorpromazine, sertindole, zotepine), not using antidepressants, mood stabilizers and other drugs, but allowing short-term use of benzodiazepines, benzhexol and propranolol;
- Signing written informed consents voluntarily.
Who cannot join
- Other severe mental illnesses, mental retardation, dementia and severe cognitive impairment according to diagnostic criteria of ICD-10 or DSM-5;
- Abnormal brain structure or function owing to any major physical disease, neurological disease, traumatic brain injury, etc.;
- Metallic implants, pacemakers, epilepsy history or other contraindications of TMS;
- Suicidal thoughts or behaviors;
- Alcohol or substance abuse;
- Pregnant or lactating women;
Show all 9Show fewer
- Other contraindications of MRI;
- Receiving regular MECT, or weight-loss therapy in the latest month;
- Other abnormal examination results considered to be inappropriate for inclusion by researchers.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Not yet recruiting
Central South University
Changsha, Hunan, 410000
Renrong Wu, Prof, +86 158 741 79855, wurenrong@csu.edu
Renrong Wu, Prof
- Recruiting
The Second People's Hospital of Dali Bai Autonomous Prefecture
Dali, Yunnan, 671014
Jin Yang, MD
About this study
Official title: Effects of Intermittent Theta Burst Stimulation (iTBS) on Increased Appetite Induced by Antipsychotics in Patients With Schizophrenia
Antipsychotics are prone to cause metabolic side effects, including weight gain, hyperglycemia, insulin resistance, hyperlipidemia and so on, leading to a 2-3 times higher risk of death in patients with schizophrenia compared to healthy people. Conventional high-frequency rTMS have been used to treat people with obesity and showed certain effectiveness. However, studies involving schizophrenia patients and intermittent theta burst (iTBS) mode are rarely seen. The goal of this clinical trial is to evaluate the efficacy and safety of iTBS on ameliorating increased appetite induced by antipsychotics in people with schizophrenia.
Read the detailed description
The study will evaluate the efficacy and safety of iTBS on ameliorating increased appetite induced by antipsychotics in people with schizophrenia by measuring changes in clinical ratings at baseline, after all the treatments, and 2 weeks, 4 weeks after intervention. 60 schizophrenia patients will be randomized to receive active or sham interventions administered to the left dorsolateral prefrontal cortex. The experimental group will be applied to active iTBS rTMS involving 600 pulses (3 minutes), 5x daily at 60 minutes intervals for 5 days. Changes in appetite from baseline to the end of the study will be measured by Three Factor Eating Questionnaire (TFEQ), Food Cravings Questionnaire-Trait (FCQ-T), Food Cravings Questionnaire-State (FCQ-S) and Visual Analogue Scale (VAS). Clinical symptoms and mood status will be assessed by Positive and Negative Symptom Scale (PANSS), the Calgary Depression Scale for Schizophrenia (CDSS) and Clinical Global Impression (CGI). Improvement of cognition could be measured by Delay Discounting Task (DDT), Stop-signal task (SST) and MATRICS (Measurement and Treatment Research to Improve Cognition in Schizophrenia) Consensus Cognitive Battery (MCCB). Changes of appetite related Indicators of glycolipid metabolism and neuroregulatory factor, along with microflora before and after intervention will be recorded by collecting blood and feces specimens. The adverse effect will be evaluated by Treatment Emergent Symptom Scale (TESS) and Adverse Event Record Form (AERF). Task-based magnetic resonance imaging (MRI) and arterial spin labeling (ASL) will be used to measure changes of brain activity associated with food stimuli and cerebral blood flow(CBF) before and after treatment.
- Conditions
- Schizophrenia
- Being tested
- Active iTBS, Sham iTBS
- Keywords
- Schizophrenia, appetite, weight, antipsychotics, iTBS
- Medical subject headings
- Schizophrenia, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active iTBSDevice
Mag-TD
Sham iTBSDevice
Mag-TD
| Study group | Role | What they receive |
|---|---|---|
| active stimulation | Active comparator | Intermittent theta burst stimulation to the dorsolateral prefrontal cortex; 5 sessions per day, for 5 days. Receives: Device: Active iTBS |
| Sham stimulation | Sham comparator | Sham stimulation to the dorsolateral prefrontal cortex; 5 sessions per day, for 5 days. Receives: Device: Sham iTBS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in body mass index (BMI)
Weight gain will be assessed by BMI, caculated by weight in kilograms divided by height in meters squared
Measured: Baseline, after 5 treatment days, 2 weeks and 4 weeks post-treatment
Secondary outcomes (29)
Changes in Positive and Negative Symptom Scale (PANSS)
Range from 30 to 210, higher score indicates more severe positive and negative symptoms.
Measured: Baseline and 4 weeks post-treatment
Changes in Calgary Depression Scale for Schizophrenia (CDSS)
Range from 0 to 27, higher score indicates more severe affective symptoms.
Measured: Baseline and 4 weeks post-treatment
Changes in the Clinical Global Impressions (CGI)
The Clinical Global Impressions (CGI) scale, quantifying the severity of psychopathology, ranging from 1 to 7 and improvements, ranging from 1 to 7 after treatments
Measured: Baseline and 4 weeks post-treatment
Changes in brain perfusion.
The arterial spin labeling (ASL) pulse sequences to quantify the cerebral blood flow (CBF).
Measured: Baseline, after 5 treatment days and 4 weeks post-treatment
Changes in brain function.
Functional MRI (fMRI) based on the blood oxygen level dependent (BOLD) contrast that can detect changes in blood oxygenation to analyze the change of brain function after intervention.
Measured: Baseline, after 5 treatment days and 4 weeks post-treatment
Changes in MCCB
The MATRICS™ Consensus Cognitive Battery
Measured: Baseline and 4 weeks post-treatment
Changes in SST.
Stop-signal task (SST) will be used to assess cognitive control.
Measured: Baseline, after 5 treatment days, 2 weeks and 4 weeks post-treatment
Changes in DDT.
Delay Discounting Task (DDT) will be used to assess impulsiveness in decision making.
Measured: Baseline, after 5 treatment days, 2 weeks and 4 weeks post-treatment
Changes in the Three-factor Eating Questionnaire (TFEQ)
TFEQ includes three domains, cognitive restraint, uncontrolled eating and emotional eating, range from 21 to 84, higher scores indicates higher appetite.
Measured: Baseline, after 5 treatment days, 2 weeks and 4 weeks post-treatment
Changes in the Food Cravings Questionnaire-Trait (FCQ-T)
Food Cravings Questionnaire-Trait (FCQ-T) is a six-point Likert scale to measure individuals' stable food craving traits containing nine factors with 39 items.
Measured: Baseline, after 5 treatment days, 2 weeks and 4 weeks post-treatment
Changes in the Food Cravings Questionnaire-State (FCQ-S)
The Food Cravings Questionnaire-State (FCQ-S) is a five-point Likert scale that measures the intensity of momentary food craving.
Measured: Baseline, after 5 treatment days, 2 weeks and 4 weeks post-treatment
Changes in the visual analogue scale (VAS)
The visual analogue scale (VAS) will be used to assess the subjective sense of appetite covering hungry, satiety, desire to eat, and overeating, scoring from 0 = "not at all" to 10 = "extremely".
Measured: Everyday from baseline to 4 weeks after treatment
Changes in the types of intestinal flora.
Feces will be collected and DNA will be extraced for quantitative analysis of intestinal flora composition.
Measured: Baseline and 4 weeks post-treatment
Changes in plasma agouti related regulatory proteins.
in ng/mL.
Measured: Baseline, after 5 treatment days and 4 weeks post-treatment
Changes in plasma serum proopioid-melanocortin.
in ng/mL.
Measured: Baseline, after 5 treatment days and 4 weeks post-treatment
Changes in plasma serum ghrelin.
in ng/mL
Measured: Baseline, after 5 treatment days and 4 weeks post-treatment
Changes in plasma serum leptin.
in ng/mL.
Measured: Baseline, after 5 treatment days and 4 weeks post-treatment
Changes in the proportion of of intestinal flora.
Feces will be collected and DNA will be extraced for quantitative analysis of intestinal flora composition.
Measured: Baseline and 4 weeks post-treatment
Changes in plasma prolactin.
in mcg/L.
Measured: Baseline, after 5 treatment days and 4 weeks post-treatment
Changes in serum total bile acids.
in mmol/l.
Measured: Baseline, after 5 treatment days and 4 weeks post-treatment
Changes in glycosylated hemoglobin.
in mmol/mol.
Measured: Baseline, after 5 treatment days and 4 weeks post-treatment
Changes in serum Low-density lipoprotein cholesterol.
in mg/dl.
Measured: Baseline, after 5 treatment days and 4 weeks post-treatment
Changes in serum high-density lipoprotein cholesterol.
in mg/dl.
Measured: Baseline, after 5 treatment days and 4 weeks post-treatment
Changes in serum total cholesterol.
in mg/dl.
Measured: Baseline, after 5 treatment days and 4 weeks post-treatment
Changes in serum triglycerides.
in mmol/l.
Measured: Baseline, after 5 treatment days and 4 weeks post-treatment
Changes in serum glucagon-like peptide-1.
in pmol/l.
Measured: Baseline, after 5 treatment days and 4 weeks post-treatment
Changes in serum glucagon.
in ng/l.
Measured: Baseline, after 5 treatment days and 4 weeks post-treatment
Changes in serum fasting insulin.
in mmol/l.
Measured: Baseline, after 5 treatment days and 4 weeks post-treatment
Changes in serum fasting blood glucose.
in mmol/l.
Measured: Baseline, after 5 treatment days and 4 weeks post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2023
- Study start1 Aug 2023
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Randomized controlled clinical trial testing iTBS versus sham
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 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
- Investigators
- Renrong Wu, M.D. Ph.D, Principal investigator, Department of Psychiatry, The Second Xiangya Hospital of Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05783063
- Sponsor's protocol ID
- WU20221015
- Status last verified
- Mar 2025
- First submitted
- 28 Feb 2023
- Last updated
- 26 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data Sharing Plan The proposed study will involve a small sample (60 patients with schizophrenia) recruited from clinical institutions of the Second People's Hospital of Dali Bai Autonomous Prefecture and the Second Xiangya Hospital of Central South University in China. The final dataset will comprise self-reported demographic and clinical characteristics, behavioral and neuroimaging data, along with laboratory data from blood and stool specimens provided by the participants. Because schizophrenia is a reportable severe mental disorder, identifying information will be collected. Although the final dataset is deidentified before it is released for sharing, we believe it is still possible to infer the disclosure of subjects with psychotic characteristics. Patients with schizophrenia belong to a vulnerable group, often accompanied by a sense of stigma. Given the social distress of the participants and the relatively limited area in which we recruited the participants, we thought it would
Publications
Qin Y, Yang J, Xu B, Yang J, Chen H, Zou T, Teng Z, Liu J, Zhang T, Su Y, Wu R, Dong Z, Yang C, Huang J. Effects of intermittent theta burst stimulation (iTBS) on appetite change and body weight in inpatients with schizophrenia in China: study protocol for a randomised controlled trial. BMJ Open. 2025 Apr 8;15(4):e090932. doi: 10.1136/bmjopen-2024-090932.
PubMed 40204331
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Intermittent Theta Burst Stimulation (iTBS) on Increased Appetite Induced by Antipsychotics in Patients With Schizophrenia
- ClinicalTrials.gov ID
- NCT05783063
- Acronym / sponsor ID
- WU20221015
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, appetite, weight, antipsychotics, iTBS
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Central South UniversityUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 24 Mar 2023 (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.
Antipsychotics are prone to cause metabolic side effects, including weight gain, hyperglycemia, insulin resistance, hyperlipidemia and so on, leading to a 2-3 times higher risk of death in patients with schizophrenia compared to healthy people. Conventional high-frequency rTMS have been used to treat people with obesity and showed certain effectiveness. However, studies involving schizophrenia patients and intermittent theta burst (iTBS) mode are rarely seen. The goal of this clinical trial is to evaluate the efficacy and safety of iTBS on ameliorating increased appetite induced by antipsychotics in people with schizophrenia.
Detailed description
The study will evaluate the efficacy and safety of iTBS on ameliorating increased appetite induced by antipsychotics in people with schizophrenia by measuring changes in clinical ratings at baseline, after all the treatments, and 2 weeks, 4 weeks after intervention. 60 schizophrenia patients will be randomized to receive active or sham interventions administered to the left dorsolateral prefrontal cortex. The experimental group will be applied to active iTBS rTMS involving 600 pulses (3 minutes), 5x daily at 60 minutes intervals for 5 days. Changes in appetite from baseline to the end of the study will be measured by Three Factor Eating Questionnaire (TFEQ), Food Cravings Questionnaire-Trait (FCQ-T), Food Cravings Questionnaire-State (FCQ-S) and Visual Analogue Scale (VAS). Clinical symptoms and mood status will be assessed by Positive and Negative Symptom Scale (PANSS), the Calgary Depression Scale for Schizophrenia (CDSS) and Clinical Global Impression (CGI). Improvement of cognition could be measured by Delay Discounting Task (DDT), Stop-signal task (SST) and MATRICS (Measurement and Treatment Research to Improve Cognition in Schizophrenia) Consensus Cognitive Battery (MCCB). Changes of appetite related Indicators of glycolipid metabolism and neuroregulatory factor, along with microflora before and after intervention will be recorded by collecting blood and feces specimens. The adverse effect will be evaluated by Treatment Emergent Symptom Scale (TESS) and Adverse Event Record Form (AERF). Task-based magnetic resonance imaging (MRI) and arterial spin labeling (ASL) will be used to measure changes of brain activity associated with food stimuli and cerebral blood flow(CBF) before and after treatment.
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 controlled clinical trial testing iTBS versus sham
| Arm | Type | Receives |
|---|---|---|
| active stimulation | Active comparator | Device: Active iTBSIntermittent theta burst stimulation to the dorsolateral prefrontal cortex; 5 sessions per day, for 5 days. |
| Sham stimulation | Sham comparator | Device: Sham iTBSSham stimulation to the dorsolateral prefrontal cortex; 5 sessions per day, for 5 days. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age between 18-40 years old;
- Meeting the diagnostic criteria for schizophrenia in DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition);
- BMI ≥ 25kg/m 2 or over 10% weight gain after taking antipsychotics in the last year;
- Not receiving TMS therapy in the past month;
- Using no more than two antipsychotic medications (including olanzapine, haloperidol, amisulpride, asenapine, risperidone, paliperidone, clozapine, quetiapine, iloperidone, chlorpromazine, sertindole, zotepine), not using antidepressants, mood stabilizers and other drugs, but allowing short-term use of benzodiazepines, benzhexol and propranolol;
Key exclusion criteria (9 listed)
- Other severe mental illnesses, mental retardation, dementia and severe cognitive impairment according to diagnostic criteria of ICD-10 or DSM-5;
- Abnormal brain structure or function owing to any major physical disease, neurological disease, traumatic brain injury, etc.;
- Metallic implants, pacemakers, epilepsy history or other contraindications of TMS;
- Suicidal thoughts or behaviors;
- Alcohol or substance abuse;
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 |
|---|---|---|
| Active iTBSMag-TD | Device | active stimulation |
| Sham iTBSMag-TD | Device | Sham stimulation |
Primary outcome
Changes in body mass index (BMI)
Time frame: Baseline, after 5 treatment days, 2 weeks and 4 weeks post-treatment
Weight gain will be assessed by BMI, caculated by weight in kilograms divided by height in meters squared
29 secondary outcomes
Changes in Positive and Negative Symptom Scale (PANSS)
Time frame: Baseline and 4 weeks post-treatment
Changes in Calgary Depression Scale for Schizophrenia (CDSS)
Time frame: Baseline and 4 weeks post-treatment
Changes in the Clinical Global Impressions (CGI)
Time frame: Baseline and 4 weeks post-treatment
Changes in brain perfusion.
Time frame: Baseline, after 5 treatment days and 4 weeks post-treatment
Changes in brain function.
Time frame: Baseline, after 5 treatment days and 4 weeks post-treatment
Changes in MCCB
Time frame: Baseline and 4 weeks post-treatment
Changes in SST.
Time frame: Baseline, after 5 treatment days, 2 weeks and 4 weeks post-treatment
Changes in DDT.
Time frame: Baseline, after 5 treatment days, 2 weeks and 4 weeks post-treatment
Changes in the Three-factor Eating Questionnaire (TFEQ)
Time frame: Baseline, after 5 treatment days, 2 weeks and 4 weeks post-treatment
Changes in the Food Cravings Questionnaire-Trait (FCQ-T)
Time frame: Baseline, after 5 treatment days, 2 weeks and 4 weeks post-treatment
Changes in the Food Cravings Questionnaire-State (FCQ-S)
Time frame: Baseline, after 5 treatment days, 2 weeks and 4 weeks post-treatment
Changes in the visual analogue scale (VAS)
Time frame: Everyday from baseline to 4 weeks after treatment
Changes in the types of intestinal flora.
Time frame: Baseline and 4 weeks post-treatment
Changes in plasma agouti related regulatory proteins.
Time frame: Baseline, after 5 treatment days and 4 weeks post-treatment
Changes in plasma serum proopioid-melanocortin.
Time frame: Baseline, after 5 treatment days and 4 weeks post-treatment
Changes in plasma serum ghrelin.
Time frame: Baseline, after 5 treatment days and 4 weeks post-treatment
Changes in plasma serum leptin.
Time frame: Baseline, after 5 treatment days and 4 weeks post-treatment
Changes in the proportion of of intestinal flora.
Time frame: Baseline and 4 weeks post-treatment
Changes in plasma prolactin.
Time frame: Baseline, after 5 treatment days and 4 weeks post-treatment
Changes in serum total bile acids.
Time frame: Baseline, after 5 treatment days and 4 weeks post-treatment
Changes in glycosylated hemoglobin.
Time frame: Baseline, after 5 treatment days and 4 weeks post-treatment
Changes in serum Low-density lipoprotein cholesterol.
Time frame: Baseline, after 5 treatment days and 4 weeks post-treatment
Changes in serum high-density lipoprotein cholesterol.
Time frame: Baseline, after 5 treatment days and 4 weeks post-treatment
Changes in serum total cholesterol.
Time frame: Baseline, after 5 treatment days and 4 weeks post-treatment
Changes in serum triglycerides.
Time frame: Baseline, after 5 treatment days and 4 weeks post-treatment
Changes in serum glucagon-like peptide-1.
Time frame: Baseline, after 5 treatment days and 4 weeks post-treatment
Changes in serum glucagon.
Time frame: Baseline, after 5 treatment days and 4 weeks post-treatment
Changes in serum fasting insulin.
Time frame: Baseline, after 5 treatment days and 4 weeks post-treatment
Changes in serum fasting blood glucose.
Time frame: Baseline, after 5 treatment days and 4 weeks post-treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2025.
- Derived from this study: PubMed 40204331Qin Y, Yang J, Xu B, Yang J, Chen H, Zou T, Teng Z, Liu J, Zhang T, Su Y, Wu R, Dong Z, Yang C, Huang J. Effects of intermittent theta burst stimulation (iTBS) on appetite change and body weight in inpatients with schizophrenia in China: study protocol for a randomised controlled trial. BMJ Open. 2025 Apr 8;15(4):e090932. doi: 10.1136/bmjopen-2024-090932.
- Individual participant dataSharing planned: No. Data Sharing Plan The proposed study will involve a small sample (60 patients with schizophrenia) recruited from clinical institutions of the Second People's Hospital of Dali Bai Autonomous Prefecture and the Second Xiangya Hospital of Central South University in China. The final dataset will comprise self-reported demographic and clinical characteristics, behavioral and neuroimaging data, along with laboratory data from blood and stool specimens provided by the participants. Because schizophrenia is a reportable severe mental disorder, identifying information will be collected. Although the final dataset is deidentified before it is released for sharing, we believe it is still possible to infer the disclosure of subjects with psychotic characteristics. Patients with schizophrenia belong to a vulnerable group, often accompanied by a sense of stigma. Given the social distress of the participants and the relatively limited area in which we recruited the participants, we thought it would
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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.
Renrong Wu, M.D. Ph.D principal investigator
Department of Psychiatry, The Second Xiangya Hospital of Central South University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active iTBS in people with Schizophrenia, run by Central South University at 2 sites 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 9 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: looking for participants now, as of the sponsor's last update on 26 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Renrong Wu, M.D. Ph.D (+8615874179855, wurenrong@csu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in body mass index (BMI) (time frame: Baseline, after 5 treatment days, 2 weeks and 4 weeks post-treatment). 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 NCT05783063, which also lists 1 linked publication.
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 26 Mar 2025.