Effect of liraglutide on depressive status in patients with type 2 diabetes mellitus and major depressive disorder: a single-center, observational cohort study

Effect of liraglutide on depressive status in patients with type 2 diabetes mellitus and major depressive disorder: a single-center, prospective cohort study

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR2300074947

Enrollment

Unknown

Registered

2023-08-21

Start date

2023-09-01

Completion date

Unknown

Last updated

2023-08-28

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

Conditions

type 2 diabetes mellitus and major depressive disorder

Interventions

Liraglutide Group:NA

Insulin group:NA

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1.To be aged 20 to 65 years; 2.Diagnosis of type 2 diabetes for more than 1 year; 3.Diagnosis of major depressive disorder by ICD-10 or DSM-5; 4.Treated with metformin/insulin secretagogue alone or in combination at a stable dosage for at least 3 months; 5.Without exposure to insulin, TZDs, GLP-1R agonist, DPP-4 inhibitor,alpha-Glucosidase during the last 3 months, or exposured to the above medication less than 7 days; 6. HbA1c concentration to be 7% to 9%; 7. Agreed to sign the informed consent file before screening and adhere the project

Exclusion criteria

Exclusion criteria: 1.Diabetic ketoacidosis or diabetic hyperosmolar attact; 2.Affected by multiple endocrine neoplasia type 2A or type 2B or with family history of medullary thyroid carcinoma; 3.Histories of persistent nausea, vomiting and other gastrointestinal symptoms, or stomach paralysis, uncontrolled gastroesophageal reflux disease, uncontrolled gastric ulcer within 6 months before enrollment; 4.Disease of the cardiovascular, liver, kidney, endocrine system or other systems, which makes it impossible to complete the research or affects the judgment of the research results; 5.Mental illness other than depression (depression with anxiety); 6.Cases of obstruction of the patient's compliance and completion of the study programme (known as the drug and alcohol abuse,etc.); 7.Pregnant or lactating women; 8.The patient's past allergies to this product; 9.In the screening of patients with adverse events, according to the researchers estimate is not suitable in this study.

Design outcomes

Primary

Measure	Time frame
HAMD-17;	—

Secondary

Measure	Time frame
TNF-a;IL-6;hs-CRP;	—

Countries

China

Contacts

Public ContactYunyi Le

Peking University Third Hospital

leyunyi@bjmu.edu.cn+86 82266722

Outcome results

None listed

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