Clinical trial NCT03043001: Memantine in Bipolar Patients With Alcoholism
Official title: Using Memantine in Treating Bipolar Disorder Comorbid With Alcoholism
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: AOD Effects and Consequences
Lead sponsor: National Cheng-Kung University Hospital
Sponsor class: OTHER
First posted: 2017-02-03
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: plasma BDNF change
timeFrame: baseline, week1, week2, week4, week8, week12
Secondary outcomes:
measure: attention change
timeFrame: baseline, 12-week
measure: Side effect change
timeFrame: baseline, week1, week2, week4, week8, week12
measure: cytokine level change
timeFrame: baseline, week1, week2, week4, week8, week12
Other outcomes:
measure: memory change
timeFrame: baseline, 12-week
measure: executive function change
timeFrame: baseline, 12-week
Locations:
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
Study officials:
affiliation: Department of Psychiatry, National Cheng Kung University
name: Ru-Band Lu, MD
role: PRINCIPAL_INVESTIGATOR
References: