Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Science and Technology Council, Taiwan | OTHER_GOV |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
All participants should fulfill the following criteria: aged between 18 and 65 years old, and of domestic Han descendants. Participants will be randomly assigned to either the (1) pharmacotherapy (valproate add-on memantine) group; (2) pharmacotherapy (valproate add-on memantine) plus Cognitive Behavior Group Therapy (CBGT) group; (3) valproate add-on placebo plus CBGT group, or (4) valproate add-on placebo only group. A total of 240-320 individuals (60-80 participants per group) will be recruited for this study. For each CBGT group, 12-weekly sessions are scheduled according to patients' preference. The investigators will attempt to understand the effects of pharmaceutical drugs for mood stabilizers add-on neuro-protective drugs, pharmacotherapy with CBGT, mood stabilizer with CBGT, and the use of only traditional mood stabilizers in the treatment of BP II. Comparisons will be made for each type of treatment and possible mechanisms will be examined regarding the pharmacotherapy and CBGT for bipolar disorder patients.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VPA & Placebo | Active Comparator | VPA & Placebo |
|
| VPA & memantine | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Memantine | Drug | 5 mg per day of memantine |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Young's Mania Rating Scale (YMRS) | Normally, YMRS is used to evaluate the Bipolar Disorder Patient's mood change. | baseline, 1, 2, 4, 8 and 12 weeks |
| Hamilton Depression Rating Scale (HDRS) | Normally, YMRS is used to evaluate the Bipolar Disorder Patient's mood change of depression. | baseline, 1, 2, 4, 8 and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| cytokines | baseline, 1, 2, 4, 8 and 12 weeks | |
| Clinical Global Impression (CGI) | CGI will be used to evaluate how the patient's adverse effect go on during the trial. | baseline, 1, 2, 4, 8 and the week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| genetics | ALDH2, ADH1B, COMT, DRD2, DRD3, BDNFVal66Met | baseline |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ru-Band Lu, MD | National Cheng-Kung University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ru-Band Lu | Tainan | 704 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24103632 | Derived | Lee SY, Chen SL, Chang YH, Chen SH, Chu CH, Huang SY, Tzeng NS, Wang CL, Wang LJ, Lee IH, Yeh TL, Yang YK, Hong JS, Lu RB. Genotype variant associated with add-on memantine in bipolar II disorder. Int J Neuropsychopharmacol. 2014 Feb;17(2):189-97. doi: 10.1017/S1461145713000825. Epub 2013 Oct 9. | |
| 23870798 | Derived |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D008559 | Memantine |
| ID | Term |
|---|---|
| D000547 | Amantadine |
| D000218 | Adamantane |
| D001952 | Bridged-Ring Compounds |
| D006844 | Hydrocarbons, Cyclic |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
|
| lipid profiles | HDL, LDL, cholesterol and etc. | baseline, 1, 2, 4, 8 and 12 weeks |
| Lee SY, Chen SL, Chang YH, Chen PS, Huang SY, Tzeng NS, Wang YS, Wang LJ, Lee IH, Yeh TL, Yang YK, Lu RB, Hong JS. Add-on memantine to valproate treatment increased HDL-C in bipolar II disorder. J Psychiatr Res. 2013 Oct;47(10):1343-8. doi: 10.1016/j.jpsychires.2013.06.017. Epub 2013 Jul 18. |
| 23826157 | Derived | Lee SY, Chen SL, Chang YH, Chen PS, Huang SY, Tzeng NS, Wang YS, Wang LJ, Lee IH, Wang TY, Yeh TL, Yang YK, Hong JS, Lu RB. Inflammation's Association with Metabolic Profiles before and after a Twelve-Week Clinical Trial in Drug-Naive Patients with Bipolar II Disorder. PLoS One. 2013 Jun 27;8(6):e66847. doi: 10.1371/journal.pone.0066847. Print 2013. |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |