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Series Studies of Bipolar Disorder-Valproate add-on Memantine

NCT01188148 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 219

Last updated 2013-09-17

No results posted yet for this study

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

DRUG

Memantine

5 mg per day of memantine

DRUG

Placebo

Sponsors & Collaborators

  • National Science and Technology Council, Taiwan

    collaborator OTHER_GOV

  • National Cheng-Kung University Hospital

    lead OTHER

Principal Investigators

  • Ru-Band Lu, MD · National Cheng-Kung University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-08-31
Primary Completion
2012-10-31
Completion
2012-10-31

Countries

  • Taiwan

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01188148 on ClinicalTrials.gov