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Clinical effects and mechanisms of GLP-1 agonist in the treatment of patients with mood disorders combined with overweight or obesity——a single-center randomized controlled intervention study

Clinical effects and mechanisms of GLP-1 agonist in the treatment of patients with mood disorders combined with overweight or obesity——a single-center randomized controlled intervention study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500114218
Enrollment
Unknown
Registered
2025-12-09
Start date
2024-11-07
Completion date
Unknown
Last updated
2025-12-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Interventions

Group A:On the basis of continuing their existing psychiatric treatment, participants will receive a 24-week intervention with the GLP-1 receptor agonist semaglutide injection (Novo Nordisk: Ozempic).
Group B:Continue existing psychiatric treatment and undergo regular psychiatric follow-up visits.

Sponsors

The Third Affiliated Hospital of Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Meets DSM-5 diagnostic criteria for either unipolar or bipolar depressive disorder in the current episode, with active disease status (non-remission) as defined by: Self-Rating Depression Scale (SDS) score >= 53 and Mood Disorder Questionnaire (MDQ) score = 30 kg/m^2; or BMI 27–29.9 kg/m^2 with at least one weight-related comorbidity, including but not limited to: impaired glucose metabolism; hypertension; dyslipidemia; obstructive sleep apnea; established cardiovascular disease; 3. Age 18–60 years (inclusive) with no gender restrictions; 4. Han Chinese, right-handed, at least completing junior high school education; 5. Willing and able to provide written informed consent after full explanation of study protocols, risks, and benefits.

Exclusion criteria

Exclusion criteria: 1.Patients with secondary obesity (e.g., hypothyroidism, Cushing's syndrome, etc.) or hyperthyroidism; 2.History or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN-2), allergy to GLP-1 receptor agonists, or other contraindications; 3. Patients who have used weight-loss medications (e.g., orlistat, GLP-1 receptor agonists, etc.) in the past 3 months; 4.History of neurological disorders or major somatic diseases (e.g., epilepsy, lupus erythematosus, infections, major trauma, glaucoma, etc.); 5.Current or past history of psychiatric disorders such as schizophrenia, bipolar disorder with psychotic features, depressive disorder with psychotic features, or substance/alcohol-induced mental disorders; 6.Hearing impairment (rough assessment: inability to hear finger-rubbing sounds) or color blindness; 7.Coagulation disorders; severe primary diseases of major organs (severe liver impairment: ALT/AST =5× upper limit of normal on two consecutive tests within the past 6 months; moderate to severe renal insufficiency (CKD stage 3 or above), eGFR <60 (CKD-EPI formula); heart failure NYHA class III-IV); 8.History of treated or untreated malignancy within the past 5 years; 9.Pregnant or breastfeeding women, or those planning to conceive in the near future; 10.Inability to fully understand the potential risks and benefits of the study; 11.Any other factors deemed by the investigator as potentially affecting the evaluation of the study’s efficacy or safety; 12.Inability to tolerate head MRI examinations.

Design outcomes

Primary

MeasureTime frame
Changes in body weight and BMI at 6 months;SDS psychological rating scale score;

Secondary

MeasureTime frame
Brain function MRI;Glucose metabolism;Lipid metabolism;Inflammatory index;Other psychiatric score;

Countries

China

Contacts

Public ContactChen Yanming

The Third Affiliated Hospital of Sun Yat-sen University

chyanm@mail.sysu.edu.cn+86 189 2210 2818

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026