Ru-Band Lu
Tainan, 704, Taiwan
NCT Number: NCT01188148
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.
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Notify Me18 year–65 year
All sexes
Interventional
Phase 2 / Phase 3
Tainan, 704, Taiwan
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
5 mg per day of memantine
Time frame: baseline, 1, 2, 4, 8 and 12 weeks
Normally, YMRS is used to evaluate the Bipolar Disorder Patient's mood change.
Time frame: baseline, 1, 2, 4, 8 and 12 weeks
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
Time frame: baseline, 1, 2, 4, 8 and the week 12
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 12 weeks
HDL, LDL, cholesterol and etc.
Time frame: baseline
ALDH2, ADH1B, COMT, DRD2, DRD3, BDNFVal66Met
National Cheng-Kung University Hospital
Other
Series Studies of Bipolar Disorder-Valproate add-on Memantine Treatment
Acronym: MM
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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