Lithium, Extended-Release |
Eskalith CR; Lithobid |
Clinical Trial: Combination Therapy for the Treatment of Bipolar Disorders
This study is currently recruiting patients.
|
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
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
Joseph R. Calabrese, MD, Principal Investigator, Case Western Reserve University / University Hospitals of Cleveland
More Information
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
Resources
- Eskalith CR (Drug Digest)
- Lithium, Extended-Release (Drug Digest)

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