NCT01188148

Series Studies of Bipolar Disorder-Valproate add-on Memantine

Series Studies of Bipolar Disorder-Valproate add-on Memantine Treatment

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 219 (actual)
• Sponsor: National Cheng-Kung University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Bipolar Disorders

Interventions

Type	Name	Description
DRUG	Memantine	5 mg per day of memantine
DRUG	Placebo

Timeline

• Start date: 2009-08-01
• Primary completion: 2012-10-01
• Completion: 2012-10-01
• First posted: 2010-08-25
• Last updated: 2013-09-17

Locations

1 site across 1 country: Taiwan