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Memantine in Bipolar Patients With Alcoholism

Sponsor
National Cheng-Kung University Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT03043001
Collaborator
(none)
60
Enrollment
1
Location
1
Arm
48
Anticipated Duration (Months)
1.3
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

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 Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Using Memantine in Treating Bipolar Disorder Comorbid With Alcoholism
Actual Study Start Date :
Jan 1, 2014
Actual Primary Completion Date :
Dec 31, 2016
Anticipated Study Completion Date :
Dec 31, 2017

Arms and Interventions

Arm Intervention/Treatment
Other: add-on memantine therapy

add-on memantine treatment

Drug: Memantine
All the subjects will receive add-on memantine for 12 week
Other Names:
  • add-on therapy

    		•

    Outcome Measures

    Primary Outcome Measures

    1. plasma BDNF change [baseline, week1, week2, week4, week8, week12]

      treatment response change assessed by plasma BDNF

    Secondary Outcome Measures

    1. attention change [baseline, 12-week]

      attention change assessed by CPT

    2. Side effect change [baseline, week1, week2, week4, week8, week12]

      adverse effect change assessed by Side-Effects Checklist

    3. cytokine level change [baseline, week1, week2, week4, week8, week12]

      cytokine change assessed by cytokines level (IL-6, IL-8, IL-10)

    Other Outcome Measures

    1. memory change [baseline, 12-week]

      memory change assessed by WMS

    2. executive function change [baseline, 12-week]

      executive function change assessed by WCST

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 National Cheng Kung University Hospital Tainan Taiwan 704

    Sponsors and Collaborators

    • National Cheng-Kung University Hospital

    Investigators

    • Principal Investigator: Ru-Band Lu, MD, Department of Psychiatry, National Cheng Kung University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ru-Band Lu, Distinguished Professor, National Cheng-Kung University Hospital
    ClinicalTrials.gov Identifier:
    NCT03043001
    Other Study ID Numbers:
    • BP_ALC_MM
    First Posted:
    Feb 3, 2017
    Last Update Posted:
    Oct 3, 2017
    Last Verified:
    Sep 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Additional relevant MeSH terms:
    Alcoholism
    Memantine

    Study Results

    No Results Posted as of Oct 3, 2017