Memantine in Bipolar Patients With Alcoholism | NCT03043001

Studies
Memantine in Bipolar Patients With Alcoholism

NCT03043001

Sponsor

National Cheng-Kung University Hospital

Status

Unknown status

Last Update Posted

Oct 3, 2017Actual

Enrollment

60Estimated

Phase

Phase 3

Conditions

AOD Effects and Consequences

Interventions

Memantine

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2014Actual

Primary Completion Date

Dec 31, 2016Actual

Completion Date

Dec 31, 2017Estimated

First Submitted Date

Jan 26, 2017

First Submission Date that Met QC Criteria

Feb 1, 2017

First Posted Date

Feb 3, 2017Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 30, 2017

Last Update Posted Date

Oct 3, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
add-on memantine therapy	Other	add-on memantine treatment	Drug: Memantine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Memantine	Drug	All the subjects will receive add-on memantine for 12 week	add-on memantine therapy

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

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

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Ru-Band Lu, MD	Department of Psychiatry, National Cheng Kung University	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
National Cheng Kung University Hospital		Tainan		704	Taiwan

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D000547	Amantadine
D000218	Adamantane
D001952	Bridged-Ring Compounds
D006844	Hydrocarbons, Cyclic