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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
219
5 mg per day of memantine
Ru-Band Lu
Tainan, Taiwan
Young's Mania Rating Scale (YMRS)
Normally, YMRS is used to evaluate the Bipolar Disorder Patient's mood change.
Time frame: 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.
Time frame: baseline, 1, 2, 4, 8 and 12 weeks
cytokines
Time frame: 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.
Time frame: baseline, 1, 2, 4, 8 and the week 12
lipid profiles
HDL, LDL, cholesterol and etc.
Time frame: baseline, 1, 2, 4, 8 and 12 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.