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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. Identifier: NCT00206778
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : November 25, 2010
Information provided by:
Beth Israel Medical Center

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 treating mixed mania in patients with Bipolar Disorder.

Condition or disease Intervention/treatment Phase
Mixed Mania Bipolar Disorder Drug: Lamotrigine Drug: Sodium Valproate Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: A Randomized Open-Label 6 Month Acute and Maintenance Trial of Lamotrigine vs. Standard of Care Sodium Valproate Monotherapy for Treatment of Mixed Mania.
Study Start Date : July 2003
Actual Primary Completion Date : July 2007
Actual Study Completion Date : July 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bipolar Disorder

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00206778

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United States, New York
Beth Israel Medical Center
New York, New York, United States, 10003
Sponsors and Collaborators
Beth Israel Medical Center
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Principal Investigator: Igor Galynker, MD, PhD Beth Israel Medical Center

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Responsible Party: Igor Galynker, MD, Beth Israel Medical Center Identifier: NCT00206778    
Other Study ID Numbers: 100-03
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: November 25, 2010
Last Verified: November 2010
Keywords provided by Beth Israel Medical Center:
Mixed mania
Bipolar Disorder
Additional relevant MeSH terms:
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Bipolar Disorder
Bipolar and Related Disorders
Mental Disorders
Valproic Acid
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Sodium Channel Blockers
Enzyme Inhibitors
GABA Agents
Neurotransmitter Agents
Antimanic Agents