<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03043001</url>
  </required_header>
  <id_info>
    <org_study_id>BP_ALC_MM</org_study_id>
    <nct_id>NCT03043001</nct_id>
  </id_info>
  <brief_title>Memantine in Bipolar Patients With Alcoholism</brief_title>
  <official_title>Using Memantine in Treating Bipolar Disorder Comorbid With Alcoholism</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Cheng-Kung University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Cheng-Kung University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Since memantine may not only inhibit overactivity of microglial cell, but also repair the&#xD;
      damaged neurons and neurogenesis through activation of astroglial cell and release of&#xD;
      neurotrophic factors, the investigators propose that the neurotrophic effect of memantine may&#xD;
      benefit neurodegenerative diseases including bipolar disorders (BP) and alcohol dependence.&#xD;
      In the current study, the investigator will investigate whether add-on memantine at a dose of&#xD;
      5 mg/day has a beneficial effect on BP comorbid with alcohol dependence.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Each individual enter into this project will receive regulate treatment adding-on memantine&#xD;
      medication. During each visit, patients will receive evaluation for their symptoms and plasma&#xD;
      Brain-Derived Neurotropic Factor (BDNF), cytokines (e.g.., Interleukin-6(IL-6), IL-8) and&#xD;
      neuropsychological performance.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date type="Actual">January 1, 2014</start_date>
  <completion_date type="Anticipated">December 31, 2017</completion_date>
  <primary_completion_date type="Actual">December 31, 2016</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>plasma BDNF change</measure>
    <time_frame>baseline, week1, week2, week4, week8, week12</time_frame>
    <description>treatment response change assessed by plasma BDNF</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>attention change</measure>
    <time_frame>baseline, 12-week</time_frame>
    <description>attention change assessed by CPT</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Side effect change</measure>
    <time_frame>baseline, week1, week2, week4, week8, week12</time_frame>
    <description>adverse effect change assessed by Side-Effects Checklist</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>cytokine level change</measure>
    <time_frame>baseline, week1, week2, week4, week8, week12</time_frame>
    <description>cytokine change assessed by cytokines level (IL-6, IL-8, IL-10)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>memory change</measure>
    <time_frame>baseline, 12-week</time_frame>
    <description>memory change assessed by WMS</description>
  </other_outcome>
  <other_outcome>
    <measure>executive function change</measure>
    <time_frame>baseline, 12-week</time_frame>
    <description>executive function change assessed by WCST</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>AOD Effects and Consequences</condition>
  <arm_group>
    <arm_group_label>add-on memantine therapy</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>add-on memantine treatment</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Memantine</intervention_name>
    <description>All the subjects will receive add-on memantine for 12 week</description>
    <arm_group_label>add-on memantine therapy</arm_group_label>
    <other_name>add-on therapy</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or female patient aged ≧18 and ≦65 years.&#xD;
&#xD;
          2. Signed informed consent by patient or legal representative.&#xD;
&#xD;
          3. The Chinese version of the modified Structural Interview of Affective Disorder and&#xD;
             Schizophrenia-L(SADS-L), a semi-structured interview aimed at formulating the main&#xD;
             bipolar II diagnoses based upon DSM-IV-TR criteria&#xD;
&#xD;
          4. A 2-day minimum for hypomania to diagnose BP.&#xD;
&#xD;
          5. Patient or a reliable caregiver was expected to ensure acceptable compliance and visit&#xD;
             attendance for the duration of the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Females who are pregnant or nursing.&#xD;
&#xD;
          2. Women of childbearing potential not using adequate contraception as per investigator&#xD;
             judgment or not willing to comply with contraception for duration of study.&#xD;
&#xD;
          3. Patient has received memantine, other anti-inflammatory medication within 1 week prior&#xD;
             to first dose of double-blind medication, such as cyclo-oxygenase 2 (Cox-2)&#xD;
             inhibitors.&#xD;
&#xD;
          4. Clinically significant medical condition e.g., cardiac, hepatic and renal disease with&#xD;
             current evidence of poor controlled.&#xD;
&#xD;
          5. Patient has received electroconvulsive therapy (ECT) within 4 weeks prior to the first&#xD;
             dose of double-blind medication.&#xD;
&#xD;
          6. Increase in total SGOT, SGPT, BUN and creatinine by more than 3X upper limit of&#xD;
             normal.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ru-Band Lu, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Psychiatry, National Cheng Kung University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>National Cheng Kung University Hospital</name>
      <address>
        <city>Tainan</city>
        <zip>704</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>January 26, 2017</study_first_submitted>
  <study_first_submitted_qc>February 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 3, 2017</study_first_posted>
  <last_update_submitted>September 30, 2017</last_update_submitted>
  <last_update_submitted_qc>September 30, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 3, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>National Cheng-Kung University Hospital</investigator_affiliation>
    <investigator_full_name>Ru-Band Lu</investigator_full_name>
    <investigator_title>Distinguished Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alcoholism</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Memantine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03043001
org study id: BP_ALC_MM
nct id: NCT03043001
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
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.
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.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: plasma BDNF change
time frame: baseline, week1, week2, week4, week8, week12
description: treatment response change assessed by plasma BDNF
measure: attention change
time frame: baseline, 12-week
description: attention change assessed by CPT
measure: Side effect change
time frame: baseline, week1, week2, week4, week8, week12
description: adverse effect change assessed by Side-Effects Checklist
measure: cytokine level change
time frame: baseline, week1, week2, week4, week8, week12
description: cytokine change assessed by cytokines level (IL-6, IL-8, IL-10)
measure: memory change
time frame: baseline, 12-week
description: memory change assessed by WMS
measure: executive function change
time frame: baseline, 12-week
description: executive function change assessed by WCST
arm group label: add-on memantine therapy
arm group type: Other
description: add-on memantine treatment
intervention type: Drug
intervention name: Memantine
description: All the subjects will receive add-on memantine for 12 week
arm group label: add-on memantine therapy
other name: add-on therapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Ru-Band Lu, MD
role: Principal Investigator
affiliation: Department of Psychiatry, National Cheng Kung University
facility: 
country: Taiwan
responsible party type: Principal Investigator
investigator affiliation: National Cheng-Kung University Hospital
investigator full name: Ru-Band Lu
investigator title: Distinguished Professor
mesh term: Alcoholism
mesh term: Memantine
sharing ipd: No