MedDataX Logo

Memantine in Bipolar Patients With Alcoholism

NCT ID: NCT03043001

Last Updated: 2017-10-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-01

Study Completion Date

2017-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

AOD Effects and Consequences

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

add-on memantine therapy

add-on memantine treatment

Group Type OTHER

Memantine

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Memantine

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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

add-on therapy

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Cheng-Kung University Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Ru-Band Lu

Distinguished Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ru-Band Lu, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Psychiatry, National Cheng Kung University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

National Cheng Kung University Hospital

Tainan City, , Taiwan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Taiwan

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

BP_ALC_MM

Identifier Type: -

Identifier Source: org_study_id