drugset / Trial / NCT04035798
add-on Low Dose Memantine in Middle-to-old Aged Bipolar II Disorder Patients
Phase 2/3
Unknown
120 enrolled
National Cheng-Kung University Hospital
Ministry of Science and Technology, Taiwan · collab
RandomizedParallel-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 2019-08-01
- Primary completion
- 2021-07-31
- Completion
- 2022-07-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Memantine | Unknown | 5 mg | — |