Memantine in Bipolar Patients With Alcoholism

AOD Effects and Consequences Clinical Trial

Official title:

Using Memantine in Treating Bipolar Disorder Comorbid With Alcoholism

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03043001
• Other study ID #: BP_ALC_MM
• Status: Enrolling by invitation
• Phase: Phase 3
• First received: January 26, 2017
• Last updated: September 30, 2017
• Start date: January 1, 2014
• Est. completion date: December 31, 2017

Study information

• Verified date: September 2017
• Source: National Cheng-Kung University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 60
• Est. completion date: December 31, 2017
• Est. primary completion date: December 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alcoholism
• AOD Effects and Consequences

Intervention

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

Locations

Country	Name	City	State
Taiwan	National Cheng Kung University Hospital	Tainan

Sponsors (1)

Lead Sponsor	Collaborator
National Cheng-Kung University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	memory change	memory change assessed by WMS	baseline, 12-week
Other	executive function change	executive function change assessed by WCST	baseline, 12-week
Primary	plasma BDNF change	treatment response change assessed by plasma BDNF	baseline, week1, week2, week4, week8, week12
Secondary	attention change	attention change assessed by CPT	baseline, 12-week
Secondary	Side effect change	adverse effect change assessed by Side-Effects Checklist	baseline, week1, week2, week4, week8, week12
Secondary	cytokine level change	cytokine change assessed by cytokines level (IL-6, IL-8, IL-10)	baseline, week1, week2, week4, week8, week12