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Combination Therapy for the Treatment of Bipolar Disorders - Article


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Lithium, Extended-Release

Eskalith CR; Lithobid



Clinical Trial: Combination Therapy for the Treatment of Bipolar Disorders

This study is currently recruiting patients.

Sponsored by: National Institute of Mental Health (NIMH)
Information provided by: National Institute of Mental Health (NIMH)

Purpose

The purpose of this study is to determine the effectiveness of a triple drug regimen and a double drug regimen in treating patients with depression, hypomania, or mania.

Condition Treatment or Intervention Phase
Bipolar Disorder
 Drug: Lithium
 Drug: Lamotrigine
 Drug: Divalproex
Phase III

MedlinePlus related topics:  Bipolar Disorder

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study

Official Title: Combination Therapy in Bipolar Rapid Cycling

Further Study Details: 

Expected Total Enrollment:  90

Study start: February 2002;  Expected completion: January 2006

Early studies have shown lithium to produce a high percentage of satisfactory clinical response in patients with bipolar disorders. These studies, however, do not include lithium-refractory subgroups, such as bipolar II disorder patients. When the wide spectrum of bipolar disorders is considered, the lithium response rate decreases significantly. More broadly effective regimens are needed.

Participants in this study will be randomly assigned to receive either lithium plus divalproex or lithium, divalproex, and lamotrigine for 6 months. Symptoms of depression and mania will be assessed with scales and patient questionnaires.

Eligibility

Ages Eligible for Study:  16 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

  • Bipolar I or II Disorder
  • Meet criteria for rapid cycling, defined as four or more episodes over the past 12 months
  • Meet criteria for a major depressive episode

Exclusion Criteria:

  • History of intolerability of lithium, divalproex, or lamotrigine

Location and Contact Information


Ohio
      University Hospitals of Cleveland, Cleveland,  Ohio,  44106,  United States; Recruiting
Renee T. Slembarski  216-844-2864    renee.slembarski@uhhs.com 

Study chairs or principal investigators

Joseph R. Calabrese, MD,  Principal Investigator,  Case Western Reserve University / University Hospitals of Cleveland   

More Information

Study ID Numbers:  62650-01A1
Record last reviewed:  January 2005
Last Updated:  January 26, 2005
Record first received:  June 25, 2003
ClinicalTrials.gov Identifier:  NCT00063362
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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November 18, 2008



Page Updated: June 1, 2005
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