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

Study Overview
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Brief Summary
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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.

Detailed Description
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The prevalence of depressive disorder is higher in individuals with chronic diseases, and the screening and management of depression is emphasized. Diabetes mellitus (DM) is a class of chronic disease and the incidence of DM has been increasing. According to previous study, 31.1% of patients with DM accompanied with depressive disorders which was higher than that of subjects without DM. Furthermore, DM as well as depression is known for risk factor for dementia. The choline metabolism involves in neuropathology of depressive disorders and individuals with depressive disorders showed the lower level of choline concentration. Choline alphoscerate is cholinergic precursor and showed the favorable clinical results in dementia management. As pseudodementia can be presented as depressive disorder and choline alphoscerate would be an option for these cases. Therefore, 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.

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

Conditions
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Type2 Diabetes With Depressive Mood

Intervention / Treatment
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* Drug: Chonline Alphoscerate
* Drug: Placebo Oral Tablet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Glitamin<br>800mg/day | Drug: Chonline Alphoscerate<br>* Patients treated with Chonline Alphoscerate as add on therapy to their medication<br>* Other names: Gliatamin;|
| Placebo Comparator: Placebo<br>same shape, color, size tablet as Glitamin | Drug: Placebo Oral Tablet<br>* Patients maintain their medication with either Gliatamin or placebo for 6 months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in Hamilton Depression Rating Scale (HDRS) | The HDRS will be scored by face-to-face interview. | 6 months after the treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in Mini-mental state examination (MMSE) score | MMSE questionnaire will be checked by careful interview and self-reported. | 6 months after the treatment |