Tests Gliatamin for low mood in people with type 2 diabetes
Tests Gliatamin against a placebo tablet in adults with type 2 diabetes and low mood.
Plain-language title generated from the registry record
Registry title: The Effect of Gliatamin (Chonline Alphoscerate) on Depressive Mood in Type 2 Diabetes Patients
Key facts
- Where
- Seoul, South KoreaSee the site
- Phase
- Phase 4
Where in South Korea
- Yonsei University College of Medicine, Department of Internal Medicine, Division of Endocrinology, Severance Hospital, Diabetes CenterSeoul, South KoreaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Yonsei University
- Trial code
- NCT03059069
- Record updated
- 24 February 2025
- Original description
The aim of this study is to investigate the effect of Gliatamin (chonline alphoscerate) on depressive mood in type 2 diabetes patients and demonstrate the impact of improved depressive mood could be influence the patient's quality of life and glycemic control.Read full original descriptionShow less
The Effect of Gliatamin (Chonline Alphoscerate) on Depressive Mood in Type 2 Diabetes Patients
The aim of this study is to investigate the effect of Gliatamin (chonline alphoscerate) on depressive mood in type 2 diabetes patients and demonstrate the impact of improved depressive mood could be influence the patient's quality of life and glycemic control.
Inclusion: Type 2 diabetic patients; Age ≥ 50; Glycemic control: HbA1c ≤ 10.0%; 10 ≤ Beck Depression Inventory (BDI) <30 points; Participants who can undergo contraception in case of being in childbearing period; Understands the study procedure, alternatives, and risks and voluntarily agrees to participate by giving written informed concent.
Exclusion: History of alcohol or drug abuse in the previous 3 months; Type 1 diabetes, Secondary diabetes, gestational diabetes; Ongoing dementia treatment or anti-depressive disorder medication; Uncontrolled psychiatric disorder; Underlying chronic liver disease (hemochromatosis, liver cell carcinoma, autoimmune liver disease, liver cirrhosis, chronic viral hepatitis); Allergy or hypersensitivity to target medication or any of its components; Renal failure, moderate or severe renal impairment (estimated glomerular filtration rate < 30 mL/min/1.73 m2), or ongoing dialysis; Human immunodeficiency virus (HIV) or human immunodeficiency virus (AIDS); chronic pancreatitis or pancreatic cancer; Abnormal liver function (AST/ALT > x3 upper normal limit); BDI ≥ 30 points; Heavy alcoholics; Premenopausal women who are nursing or pregnant.