NCT07589647 Research on the Efficacy and Safety of Targeted Suprachiasmatic Nucleus Electrical Stimulation for Improving Metabolic Disorders in Patients With Stable Bipolar Disorder Comorbid With Obesity
| NCT ID | NCT07589647 |
| Status | Recruiting |
| Phase | — |
| Sponsor | First Affiliated Hospital of Zhejiang University |
| Condition | Bipolar Disorder (BD) |
| Study Type | INTERVENTIONAL |
| Enrollment | 70 participants |
| Start Date | 2026-04-27 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 70 participants in total. It began in 2026-04-27 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study aims to stabilize the patients with bipolar disorder (BD) comorbid with obesity in the stable phase by using temporal interference stimulation (TIS ) intervention. It intends to investigate the changes in key metabolic molecules such as GLP-1 circadian rhythm, and further explore the molecular mechanism of their metabolic disorders.
Eligibility Criteria
Inclusion Criteria: 1. Both biological parents are of Han ethnicity; 2. Age range: 18 to 45 years old, gender not restricted; 3. Meets the clinical diagnostic criteria for bipolar disorder as stipulated in the 5th edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5); 4. Body Mass Index (BMI) ≥ 28 kg/m2, or for males, waist circumference ≥ 90 cm and for females, waist circumference ≥ 85 cm; 5. HAMD-24 score \< 7 points, YMRS score \< 5 points; 6. All included researchers and their family members have given informed consent for this study. Exclusion Criteria: 221/5000 1. Individuals with other DSM-5 spectrum disorders; 2. Mental disorders caused by substance abuse (such as alcohol, drugs, etc.), and those with severe physical illnesses; 3. Those who consumed food or microecological preparations containing probiotics, prebiotics, etc. within one week before enrollment, and had a history of respiratory, urinary, digestive system infections and antibiotic use within one month before enrollment; 4. Those currently having serious suicidal thoughts or behaviors, or those with severe agitation; 5. Those who cannot follow medical advice for treatment, or those without guardians; 6. Pregnant or lactating women, or those planning to become pregnant; 7. Those who cannot complete MRI examinations due to special conditions such as having metal implants or pacemakers in their bodies.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07589647 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 45 Years, studying Bipolar Disorder (BD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07589647 currently recruiting?
Yes, NCT07589647 is actively recruiting participants. Contact the research team at dorhushaohua@zju.deu.cn for enrollment information.
Where is the NCT07589647 trial being conducted?
This trial is being conducted at Hangzhou, China.
Who is sponsoring the NCT07589647 clinical trial?
NCT07589647 is sponsored by First Affiliated Hospital of Zhejiang University. The trial plans to enroll 70 participants.
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