Back to resultsMemantine in Bipolar Patients With Alcoholism
Primary Purpose
AOD Effects and Consequences
Status
Unknown status
Phase
Phase 3
Locations
Taiwan
Study Type
Interventional
Intervention
Memantine
Sponsored by
About this trial
This is an interventional treatment trial for AOD Effects and Consequences
Eligibility Criteria
Inclusion Criteria:
- Male or female patient aged ≧18 and ≦65 years.
- Signed informed consent by patient or legal representative.
- The Chinese version of the modified Structural Interview of Affective Disorder and Schizophrenia-L(SADS-L), a semi-structured interview aimed at formulating the main bipolar II diagnoses based upon DSM-IV-TR criteria
- A 2-day minimum for hypomania to diagnose BP.
- Patient or a reliable caregiver was expected to ensure acceptable compliance and visit attendance for the duration of the study.
Exclusion Criteria:
- Females who are pregnant or nursing.
- Women of childbearing potential not using adequate contraception as per investigator judgment or not willing to comply with contraception for duration of study.
- Patient has received memantine, other anti-inflammatory medication within 1 week prior to first dose of double-blind medication, such as cyclo-oxygenase 2 (Cox-2) inhibitors.
- Clinically significant medical condition e.g., cardiac, hepatic and renal disease with current evidence of poor controlled.
- Patient has received electroconvulsive therapy (ECT) within 4 weeks prior to the first dose of double-blind medication.
- Increase in total SGOT, SGPT, BUN and creatinine by more than 3X upper limit of normal.
Sites / Locations
- National Cheng Kung University Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
add-on memantine therapy
Arm Description
add-on memantine treatment
Outcomes
Primary Outcome Measures
plasma BDNF change
treatment response change assessed by plasma BDNF
Secondary Outcome Measures
attention change
attention change assessed by CPT
Side effect change
adverse effect change assessed by Side-Effects Checklist
cytokine level change
cytokine change assessed by cytokines level (IL-6, IL-8, IL-10)
Full Information
NCT ID
NCT03043001
First Posted
January 26, 2017
Last Updated
September 30, 2017
Sponsor
National Cheng-Kung University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03043001
Brief Title
Memantine in Bipolar Patients With Alcoholism
Official Title
Using Memantine in Treating Bipolar Disorder Comorbid With Alcoholism
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2014 (Actual)
Primary Completion Date
December 31, 2016 (Actual)
Study Completion Date
December 31, 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Cheng-Kung University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Since memantine may not only inhibit overactivity of microglial cell, but also repair the damaged neurons and neurogenesis through activation of astroglial cell and release of neurotrophic factors, the investigators propose that the neurotrophic effect of memantine may benefit neurodegenerative diseases including bipolar disorders (BP) and alcohol dependence. In the current study, the investigator will investigate whether add-on memantine at a dose of 5 mg/day has a beneficial effect on BP comorbid with alcohol dependence.
Detailed Description
Each individual enter into this project will receive regulate treatment adding-on memantine medication. During each visit, patients will receive evaluation for their symptoms and plasma Brain-Derived Neurotropic Factor (BDNF), cytokines (e.g.., Interleukin-6(IL-6), IL-8) and neuropsychological performance.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
AOD Effects and Consequences
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
add-on memantine therapy
Arm Type
Other
Arm Description
add-on memantine treatment
Intervention Type
Drug
Intervention Name(s)
Memantine
Other Intervention Name(s)
add-on therapy
Intervention Description
All the subjects will receive add-on memantine for 12 week
Primary Outcome Measure Information:
Title
plasma BDNF change
Description
treatment response change assessed by plasma BDNF
Time Frame
baseline, week1, week2, week4, week8, week12
Secondary Outcome Measure Information:
Title
attention change
Description
attention change assessed by CPT
Time Frame
baseline, 12-week
Title
Side effect change
Description
adverse effect change assessed by Side-Effects Checklist
Time Frame
baseline, week1, week2, week4, week8, week12
Title
cytokine level change
Description
cytokine change assessed by cytokines level (IL-6, IL-8, IL-10)
Time Frame
baseline, week1, week2, week4, week8, week12
Other Pre-specified Outcome Measures:
Title
memory change
Description
memory change assessed by WMS
Time Frame
baseline, 12-week
Title
executive function change
Description
executive function change assessed by WCST
Time Frame
baseline, 12-week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female patient aged ≧18 and ≦65 years.
Signed informed consent by patient or legal representative.
The Chinese version of the modified Structural Interview of Affective Disorder and Schizophrenia-L(SADS-L), a semi-structured interview aimed at formulating the main bipolar II diagnoses based upon DSM-IV-TR criteria
A 2-day minimum for hypomania to diagnose BP.
Patient or a reliable caregiver was expected to ensure acceptable compliance and visit attendance for the duration of the study.
Exclusion Criteria:
Females who are pregnant or nursing.
Women of childbearing potential not using adequate contraception as per investigator judgment or not willing to comply with contraception for duration of study.
Patient has received memantine, other anti-inflammatory medication within 1 week prior to first dose of double-blind medication, such as cyclo-oxygenase 2 (Cox-2) inhibitors.
Clinically significant medical condition e.g., cardiac, hepatic and renal disease with current evidence of poor controlled.
Patient has received electroconvulsive therapy (ECT) within 4 weeks prior to the first dose of double-blind medication.
Increase in total SGOT, SGPT, BUN and creatinine by more than 3X upper limit of normal.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ru-Band Lu, MD
Organizational Affiliation
Department of Psychiatry, National Cheng Kung University
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Cheng Kung University Hospital
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Memantine in Bipolar Patients With Alcoholism
We'll reach out to this number within 24 hrs