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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.
ClinicalTrials.gov IDNCT03059069
PhasePHASE4
Enrollment60
SponsorYonsei University
Age50 Years
SexALL
Conditions studied
Type2 Diabetes With Depressive Mood
About this study
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.
Interventions
- Drug: Chonline Alphoscerate — Patients treated with Chonline Alphoscerate as add on therapy to their medication
- Drug: Placebo Oral Tablet — Patients maintain their medication with either Gliatamin or placebo for 6 months.
Primary outcomes
- changes in Hamilton Depression Rating Scale (HDRS) (6 months after the treatment)
Eligibility information
Inclusion Criteria:
* 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 Criteria:
* 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
Study locations
- Yonsei University College of Medicine, Department of Internal Medicine, Division of Endocrinology, Severance Hospital, Diabetes Center, Seoul, 03722 South Korea
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.