Series Studies of Bipolar Disorder-Valproate add-on Memantine (MM)
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|ClinicalTrials.gov Identifier: NCT01188148|
Recruitment Status : Completed
First Posted : August 25, 2010
Last Update Posted : September 17, 2013
|Condition or disease||Intervention/treatment||Phase|
|Bipolar Disorders||Drug: Memantine Drug: Placebo||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||219 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Series Studies of Bipolar Disorder-Valproate add-on Memantine Treatment|
|Study Start Date :||August 2009|
|Actual Primary Completion Date :||October 2012|
|Actual Study Completion Date :||October 2012|
Active Comparator: VPA & Placebo
VPA & Placebo
|Experimental: VPA & memantine||
5 mg per day of memantine
- Young's Mania Rating Scale (YMRS) [ Time Frame: baseline, 1, 2, 4, 8 and 12 weeks ]Normally, YMRS is used to evaluate the Bipolar Disorder Patient's mood change.
- Hamilton Depression Rating Scale (HDRS) [ 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.
- cytokines [ Time Frame: baseline, 1, 2, 4, 8 and 12 weeks ]
- Clinical Global Impression (CGI) [ 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.
- lipid profiles [ Time Frame: baseline, 1, 2, 4, 8 and 12 weeks ]HDL, LDL, cholesterol and etc.
- genetics [ Time Frame: baseline ]ALDH2, ADH1B, COMT, DRD2, DRD3, BDNFVal66Met
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01188148
|Tainan, Taiwan, 704|
|Principal Investigator:||Ru-Band Lu, MD||National Cheng-Kung University Hospital|