Bipolar Disorder II
Conditions
Keywords
dextromethorphan; memantine; treatment response
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.
Interventions
DRUGDextromethorphan
DRUGMemantine
DRUGdextromethorphan+memantine
DRUGplacebo+valproate
Sponsors
National Cheng-Kung University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| treatment change assessed by plasma levels of cytokines (e.g., IL-6, IL-8) | baseline, week 1, week 2, week 4, week 8, week 12 | change assessment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| depression change change | baseline, week 1, week 2, week 4, week 8, week 12 | depression change assessed by Hamilton Depression Rating Scale |
| manic state change | baseline, week 1, week 2, week 4, week 8, week 12 | Manic symptom assessed by Young Mania Rating Scale |
Other
| Measure | Time frame | Description |
|---|---|---|
| executive functioning change | baseline, week 12 | executive function change assessed by WCST |
| attention function change | baseline, week 12 | attention change assessed by CPT |
| memory change | baseline, week 12 | memory change assessed by WMS |
Countries
Taiwan
Outcome results
None listed