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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT03043001 |
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Date of registration:
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26/01/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Memantine in Bipolar Patients With Alcoholism
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Scientific title:
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Using Memantine in Treating Bipolar Disorder Comorbid With Alcoholism |
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Date of first enrolment:
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January 1, 2014 |
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Target sample size:
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60 |
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Recruitment status: |
Enrolling by invitation |
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URL:
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https://clinicaltrials.gov/show/NCT03043001 |
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Study type:
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Interventional |
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Study design:
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Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 3
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Countries of recruitment
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Taiwan
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Contacts
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Name:
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Ru-Band Lu, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Department of Psychiatry, National Cheng Kung University |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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AOD Effects and Consequences
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Intervention(s)
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Drug: Memantine
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Primary Outcome(s)
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plasma BDNF change
[Time Frame: baseline, week1, week2, week4, week8, week12]
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Secondary Outcome(s)
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Side effect change
[Time Frame: baseline, week1, week2, week4, week8, week12]
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cytokine level change
[Time Frame: baseline, week1, week2, week4, week8, week12]
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attention change
[Time Frame: baseline, 12-week]
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Secondary ID(s)
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BP_ALC_MM
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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