Six Month Trial of Lamotrigine vs. Sodium Valproate for Treatment of Mixed Mania

• Status: Completed
• Trial end date: 2007-07-01
• Target enrollment: 0
• Participant gender: All

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 treating mixed mania in patients with Bipolar Disorder.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beth Israel Medical Center
• Treatments: Anticonvulsants; Lamotrigine; Valproic Acid

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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