Ignite Creation Date:
2024-05-05 @ 10:46 PM
Last Modification Date:
2024-10-26 @ 10:24 AM
Study NCT ID:
NCT01188148
Status:
COMPLETED
Last Update Posted:
2013-09-17
First Post:
2010-08-23
Brief Title:
Series Studies of Bipolar Disorder-Valproate add-on Memantine
Sponsor:
National Cheng-Kung University Hospital
Organization:
National Cheng-Kung University Hospital
Study Overview
Official Title:
Series Studies of Bipolar Disorder-Valproate add-on Memantine Treatment
Status:
COMPLETED
Status Verified Date:
2009-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MM
Brief Summary:
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None