Combination of Dextromethorphan and Memantine in Treating Bipolar Disorder
Trial Snapshot
- Phase
- Phase 3
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- treatment change assessed by plasma levels of cytokines (e.g., IL-6, IL-8)
Study Overview
Brief Summary
This is a research clinical trial of double-blind, stratified randomized, parallel group, two-centre study. It will be conducted in a total of 250~300 male and female subjects from the Department of Psychiatry at National Cheng Kung University Hospital. Eligible subjects will be psychiatric out- and in-patients, aged between 18~65 years old, who have psychiatric evaluation with clinically suspected of having bipolar II disorder and fulfill the inclusion and exclusion criteria. The add-on double-blind study treatment with dextromethorphan/place will commence at randomization for while patients continue open-label valproate. Subjects will be enrolled for 12 weeks double-blind add-on treatment and randomly assigned to (1) 30mg dextromethorphan+valproate, (2) 5mg memantine+valproate, (3) dextromethorphan+memantine+valproate or (4) placebo+valproate. Concomitant benzodiazepine medication (preferably up to 8mg lorazepam) may be used for daytime sedation, agitation or insomnia during the study. For the consideration of the less influence to immune-system, resperidone 1-3mg/daily and fluoxetine maximum 20mg/daily will be chose. We will measure the treatment response and side effect to clarify the curative effect of DM and memantine add-on therapy to valproate in the treatment of bipolar disorders. This study is being performed to investigate the possibly significant beneficial effects on the subtypes of bipolar disorders psychopathology.
Detailed Description
A total of 250~300 male and female subjects from the Department of Psychiatry at National Cheng Kung University Hospital. Eligible subjects who are aged between 18~65 years old and clinically suspected of having bipolar II disorder are invited. The add-on double-blind study treatment with dextromethorphan/place will commence at randomization for while patients continue open-label valproate. Subjects will be enrolled for 12 weeks double-blind add-on treatment and randomly assigned to (1) 30mg dextromethorphan+valproate, (2) 5mg memantine+valproate, (3) dextromethorphan+memantine+valproate or (4) placebo+valproate. Concomitant benzodiazepine medication (preferably up to 8mg lorazepam) may be used for daytime sedation, agitation or insomnia during the study. For the consideration of the less influence to immune-system, resperidone 1-3mg/daily and fluoxetine maximum 20mg/daily will be chose. We will measure the treatment response and side effect to clarify the curative effect of DM and memantine add-on therapy to valproate in the treatment of bipolar disorders. This study is being performed to investigate the possibly significant beneficial effects on the subtypes of bipolar disorders psychopathology.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •A 2-day minimum for hypomania to diagnose bipolar II disorder
- •A total of Hamilton Rating Scale for Depression scored at least 18 or Young Mania Rating Scale scored at least 14 at the screening stage
- •Must allow to ensure acceptable compliance and visit
Exclusion Criteria
- •Pregnant females or nursing
- •Women of childbearing potential not using adequate contraception
- •Received dextromethorphan, memantine, other antiinflammatory medication within 1 week prior
- •Clinically significant medical condition (cardiac, hepatic and renal disease)
- •Received electroconvulsive therapy patients 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.
Arms & Interventions
30 mg DM
30mg dextromethorphan+valproate
Intervention: Dextromethorphan (Drug)
5 mg MM
5mg memantine+valproate
Intervention: Memantine (Drug)
DM+MM
dextromethorphan+memantine+ valproate
Intervention: dextromethorphan+memantine (Drug)
placebo
Placebo+valproate
Intervention: placebo+valproate (Drug)
Outcomes
Primary Outcomes
treatment change assessed by plasma levels of cytokines (e.g., IL-6, IL-8)
Time Frame: baseline, week 1, week 2, week 4, week 8, week 12
change assessment
Secondary Outcomes
- depression change change(baseline, week 1, week 2, week 4, week 8, week 12)
- manic state change(baseline, week 1, week 2, week 4, week 8, week 12)
Investigators
Ru-Band Lu
Distinguished Professor
National Cheng-Kung University Hospital