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

Completed · Phase 2

Conditions studied: Mixed Mania Bipolar Disorder

In brief

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.

Key facts

Study ID

NCT00206778

Run by

Beth Israel Medical Center

People needed

36

Starts

2003-07-01

Expected to finish

2007-07-01

Last updated by the study team

2010-11-25

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Beth Israel Medical Center — New York, New York, United States

Full record on ClinicalTrials.gov

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