AOD Effects and ConsequencesPhase 3NCT03043001
Memantine in Bipolar Patients With Alcoholism
A Phase 3 study testing Memantine in people with AOD Effects and Consequences, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- AOD Effects and Consequences
- What is being tested?
- Memantine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2014to 31 Dec 2017
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- AOD Effects and Consequences
- Being tested
- Memantine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MemantineDrug
Also called add-on therapy
All the subjects will receive add-on memantine for 12 week
| Study group | Role | What they receive |
|---|---|---|
| add-on memantine therapy | Other | add-on memantine treatment Receives: Drug: Memantine |
What is being measured
The primary outcome is the main question the study is designed to answer.
plasma BDNF change
treatment response change assessed by plasma BDNF
Measured: baseline, week1, week2, week4, week8, week12
Secondary outcomes (3)
attention change
attention change assessed by CPT
Measured: baseline, 12-week
Side effect change
adverse effect change assessed by Side-Effects Checklist
Measured: baseline, week1, week2, week4, week8, week12
cytokine level change
cytokine change assessed by cytokines level (IL-6, IL-8, IL-10)
Measured: baseline, week1, week2, week4, week8, week12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2017 (estimated)
- Study start1 Jan 2014
- Primary completion31 Dec 2016
- Study completion31 Dec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AOD Effects and ConsequencesStudies of the same condition, open and under way.
- More trials run by National Cheng-Kung University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cheng-Kung University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ru-Band Lu, National Cheng-Kung University Hospital
- Investigators
- Ru-Band Lu, MD, Principal investigator, Department of Psychiatry, National Cheng Kung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03043001
- Sponsor's protocol ID
- BP_ALC_MM
- Status last verified
- Sep 2017
- First submitted
- 26 Jan 2017
- Last updated
- 3 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Memantine in Treating Bipolar Disorder Comorbid With Alcoholism
- ClinicalTrials.gov ID
- NCT03043001
- Acronym / sponsor ID
- BP_ALC_MM
- Conditions
- AOD Effects and Consequences
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- National Cheng-Kung University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Dec 2017 (estimated)
- First posted
- 3 Feb 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| add-on memantine therapy | Other | Drug: Memantineadd-on memantine treatment |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MemantineAlso: add-on therapyAll the subjects will receive add-on memantine for 12 week | Drug | add-on memantine therapy |
Primary outcome
plasma BDNF change
Time frame: baseline, week1, week2, week4, week8, week12
treatment response change assessed by plasma BDNF
3 secondary outcomes
attention change
Time frame: baseline, 12-week
Side effect change
Time frame: baseline, week1, week2, week4, week8, week12
cytokine level change
Time frame: baseline, week1, week2, week4, week8, week12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2017.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ru-Band Lu, MD principal investigator
Department of Psychiatry, National Cheng Kung University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Memantine in people with AOD Effects and Consequences, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
plasma BDNF change (time frame: baseline, week1, week2, week4, week8, week12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2017.