Six Month Trial of Lamotrigine vs. Sodium Valproate for Treatment of Mixed Mania
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.
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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study:
18 Years to 65 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.
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