Memantine in Bipolar Patients With Alcoholism

NCT03043001 | Unknown Phase 3

• 1 other identifier: BP_ALC_MM
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

AOD Effects and Consequences

Outcome Measures

Primary Outcomes (1)

• plasma BDNF change

  treatment response change assessed by plasma BDNF

  baseline, week1, week2, week4, week8, week12

Secondary Outcomes (3)

• attention change

  baseline, 12-week

• Side effect change

  baseline, week1, week2, week4, week8, week12

• cytokine level change

  baseline, week1, week2, week4, week8, week12

Other Outcomes (2)

• memory change

  baseline, 12-week

• executive function change

  baseline, 12-week

Study Arms (1)

add-on memantine therapy

OTHER

add-on memantine treatment

Drug: Memantine

Interventions

Memantine DRUG

All the subjects will receive add-on memantine for 12 week

Also known as: add-on therapy

add-on memantine therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patient aged ≧18 and ≦65 years.
• Signed informed consent by patient or legal representative.
• 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
• A 2-day minimum for hypomania to diagnose BP.
• Patient or a reliable caregiver was expected to ensure acceptable compliance and visit attendance for the duration of the study.

You may not qualify if:

• Females who are pregnant or nursing.
• Women of childbearing potential not using adequate contraception as per investigator judgment or not willing to comply with contraception for duration of study.
• 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.
• Clinically significant medical condition e.g., cardiac, hepatic and renal disease with current evidence of poor controlled.
• Patient has received electroconvulsive therapy (ECT) within 4 weeks prior to the first dose of double-blind medication.
• Increase in total SGOT, SGPT, BUN and creatinine by more than 3X upper limit of normal.

Sponsors & Collaborators

• National Cheng-Kung University Hospital: lead

Study Sites (1)

National Cheng Kung University Hospital

Tainan, 704, Taiwan

Location

MeSH Terms

Interventions

Memantine

Intervention Hierarchy (Ancestors)

Amantadine; Adamantane; Bridged-Ring Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Ru-Band Lu, MD

  Department of Psychiatry, National Cheng Kung University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Distinguished Professor

Study Record Dates

• First Submitted: January 26, 2017
• First Posted: February 3, 2017
• Study Start: January 1, 2014
• Primary Completion: December 31, 2016
• Study Completion: December 31, 2017
• Last Updated: October 3, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)