The Effect of Gliatamin (Chonline Alphoscerate) on Depressive Mood in Type 2 Diabetes Patients
Recruiting now · Phase 4 · Has a placebo group
Conditions studied: Type2 Diabetes With Depressive Mood
In brief
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.
Key facts
- Study ID
- NCT03059069
- Run by
- Yonsei University
- People needed
- 60
- Starts
- 2016-06-01
- Expected to finish
- 2025-06-30
- Last updated by the study team
- 2025-02-24
Who can join
Age: 50 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- Type 1 diabetes, Secondary diabetes, gestational diabetes
- Ongoing dementia treatment or anti-depressive disorder medication
- Uncontrolled psychiatric disorder
- BDI ≥ 30 points
- Heavy alcoholics
- 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
- Abnormal liver function (AST/ALT > x3 upper normal limit)
- History of alcohol or drug abuse in the previous 3 months
- Premenopausal women who are nursing or pregnant
- Human immunodeficiency virus (HIV) or human immunodeficiency virus (AIDS)
- chronic pancreatitis or pancreatic cancer
Where it is running
- Yonsei University College of Medicine, Department of Internal Medicine, Division of Endocrinology, Severance Hospital, Diabetes Center — Seoul, South Korea (enrolling)
Full record on ClinicalTrials.gov
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