Status:
COMPLETED
Six Month Trial of Lamotrigine vs. Sodium Valproate for Treatment of Mixed Mania
Lead Sponsor:
Beth Israel Medical Center
Conditions:
Mixed Mania Bipolar Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
We are comparing the efficacy of Lamotrigine to that of Standard of Care Sodium Valproate for the treatment of Mixed Mania. The study hypothesis is that Lamotrigine will be more efficative for treatin...
Detailed Description
Mixed mania is a clinically distinct affective state which is likely to be more severe than classical euphoric mania and to have longer episode duration. Mixed mania is associated with longer duration...
Eligibility Criteria
Inclusion
- Males and females, ages 18-65.
- Ability to sign an informed consent
- Diagnosis of Bipolar Mood Disorder I, manic episode.
- Mania Rating Scale (MRS) score of at least 11
- HDRS score of at least 18
- Global Assessment Scale (GAS) scores more than 60.
Exclusion
- Alcohol or substance abuse within the last 6 months
- Current diagnosis of Obsessive-Compulsive Disorder
- Current diagnosis of Schizophrenia or Schizoaffective Disorder
- Previous adverse reaction or allergies to lamotrigine or sodium valproate
Key Trial Info
Start Date :
July 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2007
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00206778
Start Date
July 1 2003
End Date
July 1 2007
Last Update
November 25 2010
Active Locations (1)
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1
Beth Israel Medical Center
New York, New York, United States, 10003