Memantine in Bipolar Patients With Alcoholism

Using Memantine in Treating Bipolar Disorder Comorbid With Alcoholism

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.

Study Overview

• Status: Unknown
• Conditions: AOD Effects and Consequences
• Intervention / Treatment: Drug: Memantine

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 3

Contacts and Locations

Study Locations

• Taiwan
  • Tainan, Taiwan, 704
    • National Cheng Kung University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
plasma BDNF change	treatment response change assessed by plasma BDNF	baseline, week1, week2, week4, week8, week12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
attention change	attention change assessed by CPT	baseline, 12-week
Side effect change	adverse effect change assessed by Side-Effects Checklist	baseline, week1, week2, week4, week8, week12
cytokine level change	cytokine change assessed by cytokines level (IL-6, IL-8, IL-10)	baseline, week1, week2, week4, week8, week12

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
memory change	memory change assessed by WMS	baseline, 12-week
executive function change	executive function change assessed by WCST	baseline, 12-week

Collaborators and Investigators

• Sponsor: National Cheng-Kung University Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2014
• Primary Completion (ACTUAL): December 31, 2016
• Study Completion (ANTICIPATED): December 31, 2017

Study Registration Dates

• First Submitted: January 26, 2017
• First Submitted That Met QC Criteria: February 1, 2017
• First Posted (ESTIMATE): February 3, 2017

Study Record Updates

• Last Update Posted (ACTUAL): October 3, 2017
• Last Update Submitted That Met QC Criteria: September 30, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Alcoholism; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Dopamine Agents; Antiparkinson Agents; Anti-Dyskinesia Agents; Memantine
• Other Study ID Numbers: BP_ALC_MM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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