Back to resultsThe Effect of Gliatamin (Chonline Alphoscerate) on Depressive Mood in Type 2 Diabetes Patients
Primary Purpose
Type2 Diabetes With Depressive Mood
Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Chonline Alphoscerate
Placebo Oral Tablet
Sponsored by
About this trial
This is an interventional treatment trial for Type2 Diabetes With Depressive Mood
Eligibility Criteria
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
Sites / Locations
- Yonsei University College of Medicine, Department of Internal Medicine, Division of Endocrinology, Severance Hospital, Diabetes CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Glitamin
Placebo
Arm Description
800mg/day
same shape, color, size tablet as Glitamin
Outcomes
Primary Outcome Measures
changes in Hamilton Depression Rating Scale (HDRS)
The HDRS will be scored by face-to-face interview.
Secondary Outcome Measures
changes in Mini-mental state examination (MMSE) score
MMSE questionnaire will be checked by careful interview and self-reported.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03059069
Brief Title
The Effect of Gliatamin (Chonline Alphoscerate) on Depressive Mood in Type 2 Diabetes Patients
Official Title
The Effect of Gliatamin (Chonline Alphoscerate) on Depressive Mood in Type 2 Diabetes Patients
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2016 (Actual)
Primary Completion Date
June 30, 2019 (Anticipated)
Study Completion Date
June 30, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type2 Diabetes With Depressive Mood
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Glitamin
Arm Type
Experimental
Arm Description
800mg/day
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
same shape, color, size tablet as Glitamin
Intervention Type
Drug
Intervention Name(s)
Chonline Alphoscerate
Other Intervention Name(s)
Gliatamin
Intervention Description
Patients treated with Chonline Alphoscerate as add on therapy to their medication
Intervention Type
Drug
Intervention Name(s)
Placebo Oral Tablet
Intervention Description
Patients maintain their medication with either Gliatamin or placebo for 6 months.
Primary Outcome Measure Information:
Title
changes in Hamilton Depression Rating Scale (HDRS)
Description
The HDRS will be scored by face-to-face interview.
Time Frame
6 months after the treatment
Secondary Outcome Measure Information:
Title
changes in Mini-mental state examination (MMSE) score
Description
MMSE questionnaire will be checked by careful interview and self-reported.
Time Frame
6 months after the treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bong-Soo Cha, MD, Ph.D
Phone
82-2-2228-5457
Email
bscha@yuhs.ac
Facility Information:
Facility Name
Yonsei University College of Medicine, Department of Internal Medicine, Division of Endocrinology, Severance Hospital, Diabetes Center
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bong Soo Cha, MD
Phone
+82-2-2228-1932
Email
bscha@yuhs.ac
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
The Effect of Gliatamin (Chonline Alphoscerate) on Depressive Mood in Type 2 Diabetes Patients
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