add-on Low Dose Memantine in Middle-to-old Aged Bipolar II Disorder Patients

NCT04035798 | Unknown Phase 2

• 1 other identifier: A-BR-107-095
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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 bipolar II disorder (BP-II) patients. In current proposal, the investigators will conduct a randomized double-blind placebo-controlled study. The investigators will recruit 100-120 patients with BP-II who are older than 40 years old in three years, and allocate them to add-on MM or placebo plus standard valproic acid treatment in a 1: 1 ratio. The investigators will follow up the participants for 12 weeks and measure the severity of mood symptoms, neuropsychological tests and inflammatory markers to evaluate the therapeutic effects of add-on MM.

Conditions

Bipolar II Disorder

Outcome Measures

Primary Outcomes (1)

• Memory function

  The participants will receive the exam of Wechsler Memory Scale-III (WMS-III) at baseline and at the endpoint (after receiving memantine or placebo treatment for 12 weeks). WMS-III composite scores were calculated for the eight standardized primary indices: Auditory Immediate (AIM, range from 50-156), Visual Immediate (VIM, range from 47-162 ), Immediate Memory (IM, range from 40-164 ), Auditory Delayed (ADM, range from 46-162), Visual Delayed (VDM, range from 43-156), Auditory Recognition Delayed (ARDM, range from 55-145), General Memory (GM, range from 40-168), and Working Memory (WM, range from 45-156 ). Higher scores indicate better performance.

  12 weeks

Secondary Outcomes (4)

• executive function

  12 weeks

• Attention

  12 weeks

• Processing speed

  12 weeks

• Inflammatory status

  12 weeks

Other Outcomes (1)

• Mood symptoms severity

  12 weeks

Study Arms (2)

memantine (MM)

EXPERIMENTAL

The participants will receive memantine 5mg (1 capsule) per day for 12 weeks.

Drug: Memantine or placebo

Placebo

PLACEBO COMPARATOR

The participants will receive one capsule of placebo per day for 12 weeks.

Drug: Memantine or placebo

Interventions

Memantine or placebo DRUG

BP-II patients who are older than 40 years old will be recruited, and allocate them to add-on memantine or placebo plus standard valproic acid treatment in a 1: 1 ratio. The participants will receive memantine 5mg/day or placebo treatment for 12 weeks.

Placebo; memantine (MM)

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• National Cheng-Kung University Hospital: lead
• Ministry of Science and Technology, Taiwan: collaborator

Study Sites (1)

Department of Psychiatry, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University

Tainan, 70428, Taiwan

RECRUITING

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Memantine

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Amantadine; Adamantane; Bridged-Ring Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Tzu-Yun Wang

  College of Medicine, National Cheng Kung University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tzu-Yun Wang

CONTACT

886-6-2353535; tzuyun0105@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 1, 2019
• First Posted: July 29, 2019
• Study Start: August 1, 2019
• Primary Completion: July 31, 2021
• Study Completion: July 31, 2022
• Last Updated: March 9, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)