Memantine in Bipolar Patients With Alcoholism

Phase 3

• Conditions: AOD Effects and Consequences
• Interventions: Drug: Memantine

• Registration Number: NCT03043001
• Lead Sponsor: National Cheng-Kung University Hospital

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.

Study Timeline

• Study Start: 2014-01-01
• Primary Completion: 2016-12-31
• Study First Submitted: 2017-01-26
• Study First Submitted QC: 2017-02-01
• Study First Posted: 2017-02-03
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-30
• Last Update Posted: 2017-10-03
• Study Completion: 2017-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
add-on memantine therapy	Memantine	add-on memantine treatment

Primary Outcome Measures

Name	Time	Method
plasma BDNF change	baseline, week1, week2, week4, week8, week12	treatment response change assessed by plasma BDNF

Secondary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

National Cheng Kung University Hospital; 🇨🇳 Tainan, Taiwan