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Clinical Trials in South Korea / NCT03059069
Recruiting Phase 4

The Effect of Gliatamin (Chonline Alphoscerate) on Depressive Mood in Type 2 Diabetes Patients

NCT03059069 · tracked via the Priya Life Science South Korea tracker
Sponsor
Yonsei University
Phase
Phase 4
Started
2016-06-01
Last updated
2025-02-24

Condition(s) studied

Type2 Diabetes With Depressive Mood

Investigational drug(s) / intervention(s)

Chonline AlphosceratePlacebo Oral Tablet

Chonline Alphoscerate: Patients treated with Chonline Alphoscerate as add on therapy to their medication

Placebo Oral Tablet: Patients maintain their medication with either Gliatamin or placebo for 6 months.

Study summary

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.

Eligibility

Sex
ALL
Min age
50 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • changes in Hamilton Depression Rating Scale (HDRS) — 6 months after the treatment
    The HDRS will be scored by face-to-face interview.

Trial sites (1)

FacilityCityRegionStatus
Yonsei University College of Medicine, Department of Internal Medicine, Division of Endocrinology, Severance Hospital, Diabetes Center Seoul South Korea Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03059069 on ClinicalTrials.gov ↗ ← All trials in South Korea