AOD Effects and Consequences
Conditions
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.
Interventions
DRUGMemantine
All the subjects will receive add-on memantine for 12 week
Sponsors
National Cheng-Kung University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Male or female patient aged ≧18 and ≦65 years. 2. Signed informed consent by patient or legal representative. 3. 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 4. A 2-day minimum for hypomania to diagnose BP. 5. Patient or a reliable caregiver was expected to ensure acceptable compliance and visit attendance for the duration of the study.
Exclusion criteria
1. Females who are pregnant or nursing. 2. Women of childbearing potential not using adequate contraception as per investigator judgment or not willing to comply with contraception for duration of study. 3. 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. 4. Clinically significant medical condition e.g., cardiac, hepatic and renal disease with current evidence of poor controlled. 5. Patient has received electroconvulsive therapy (ECT) within 4 weeks prior to the first dose of double-blind medication. 6. Increase in total SGOT, SGPT, BUN and creatinine by more than 3X upper limit of normal.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| plasma BDNF change | baseline, week1, week2, week4, week8, week12 | treatment response change assessed by plasma BDNF |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| attention change | baseline, 12-week | attention change assessed by CPT |
| Side effect change | baseline, week1, week2, week4, week8, week12 | adverse effect change assessed by Side-Effects Checklist |
| cytokine level change | baseline, week1, week2, week4, week8, week12 | cytokine change assessed by cytokines level (IL-6, IL-8, IL-10) |
Other
| Measure | Time frame | Description |
|---|---|---|
| memory change | baseline, 12-week | memory change assessed by WMS |
| executive function change | baseline, 12-week | executive function change assessed by WCST |
Countries
Taiwan
Outcome results
None listed