Six Month Trial of Lamotrigine vs. Sodium Valproate for Treatment of Mixed Mania
This study has been completed.
Information provided by:
Beth Israel Medical Center
First received: September 16, 2005
Last updated: November 24, 2010
Last verified: November 2010
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.
Mixed Mania Bipolar Disorder
Drug: Sodium Valproate
Intervention Model: Crossover Assignment
Masking: Single Blind
Primary Purpose: Treatment
||A Randomized Open-Label 6 Month Acute and Maintenance Trial of Lamotrigine vs. Standard of Care Sodium Valproate Monotherapy for Treatment of Mixed Mania.
| Estimated Enrollment:
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||July 2007 (Final data collection date for primary outcome measure)
|Ages Eligible for Study:
||18 Years to 65 Years
|Genders 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
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, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00206778
|Beth Israel Medical Center
|New York, New York, United States, 10003 |
Beth Israel Medical Center
||Igor Galynker, MD, PhD
||Beth Israel Medical Center
No publications provided
||Igor Galynker, MD, Beth Israel Medical Center
History of Changes
|Other Study ID Numbers:
|Study First Received:
||September 16, 2005
||November 24, 2010
||United States: Food and Drug Administration
Keywords provided by Beth Israel Medical Center:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on February 27, 2015
Affective Disorders, Psychotic
Calcium Channel Blockers
Central Nervous System Agents
Central Nervous System Depressants
Excitatory Amino Acid Agents
Excitatory Amino Acid Antagonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Sodium Channel Blockers
Voltage-Gated Sodium Channel Blockers