NCT03059069RecruitingPhase 4
The Effect of Gliatamin (Chonline Alphoscerate) on Depressive Mood in Type 2 Diabetes Patients
Source: ClinicalTrials.gov · Last updated 24 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 15 Feb 2017
- Start date
- 1 Jun 2016
- Primary completion date
- 30 Jun 2025
- Lead sponsor
- Yonsei University
- Diseases
- Type 2 diabetes
- NCT number
- NCT03059069
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 60
- From 1 Jun 2016 to the primary completion date, 30 Jun 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of alcohol or drug abuse in the previous 3 months
Other illness
- 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
Lab values
- Abnormal liver function (AST/ALT \> x3 upper normal limit)
Other
- BDI ≥ 30 points
- Heavy alcoholics
- Premenopausal women who are nursing or pregnant
Who the study is looking for
- 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
Age in the registry: 50 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Yonsei University College of Medicine, Department of Internal Medicine, Division of Endocrinology, Severance Hospital, Diabetes Center Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.