Status:
UNKNOWN
add-on Low Dose Memantine in Middle-to-old Aged Bipolar II Disorder Patients
Lead Sponsor:
National Cheng-Kung University Hospital
Collaborating Sponsors:
Ministry of Science and Technology, Taiwan
Conditions:
Bipolar II Disorder
Eligibility:
All Genders
40+ years
Phase:
PHASE2
PHASE3
Brief Summary
The investigators hypothesized that add-on memantine (MM) 5 mg/day may reduce chronic inflammation, and subsequently improve neuro-progression process and cognitive function in middle-to-old aged bipo...
Detailed Description
Emerging evidence showed that chronic inflammation and neuro-progression underlie bipolar disorder (BP). There were several neurobiological similarities between neuro-progression in BP and aging. Pati...
Eligibility Criteria
Inclusion
- Signed informed consent by patient or legal representative.
- Male or female patient aged ≧40 years.
- A diagnosis of bipolar II disorder according to Diagnostic and Statistical Manual of Mental Disorders criteria made by a specialist in psychiatry.
- Patient or a reliable caregiver can be expected to ensure acceptable compliance and visit attendance for the duration of the study.
Exclusion
- The presence of any of the following will exclude a patient from study enrollment:
- Women of childbearing potential, not using adequate contraception as per investigator judgment or not willing to comply with contraception for the duration of the study.
- Females who are pregnant or lactation.
- Comorbid with substance-related disorders, borderline personality disorder, schizophrenia, mental retardation, dementia or other major psychiatric disorders. But comorbid with anxiety disorder or tobacco use disorder is not an exclusion criteria.
- Current evidence of an uncontrolled and/or clinically significant medical condition, e.g., cardiac, hepatic and renal failure that would compromise patient safety or preclude study participation.
- History of allergy or intolerable side effects of valproic acid, memantine, risperidone, fluoxetine, lorazepam.
- History of receiving electroconvulsive therapy.
- Levels of total bilirubin, aspartate aminotransferase(AST)、alanine transaminase(ALT) were elevated more than twice of normal range. Levels of Blood urea nitrogen(BUN) and creatinine were elevated more than three times of normal range.
- Presence of alcohol abuse/dependence or illicit drug abuse/dependence in previous 6 months before beginning of study.
Key Trial Info
Start Date :
August 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2022
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04035798
Start Date
August 1 2019
End Date
July 31 2022
Last Update
March 9 2021
Active Locations (1)
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1
Department of Psychiatry, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University
Tainan, Taiwan, 70428