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Combination Therapy for the Treatment of Bipolar Disorders

This study has been terminated.
(F Funding Expiration)
Sponsor:
Information provided by:
National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:
NCT00063362
First received: June 25, 2003
Last updated: February 8, 2008
Last verified: February 2008
History of Changes
  Purpose

This study will compare triple and double drug regimens in the treatment of patients with depression, hypomania, or mania.


Condition Intervention Phase
Bipolar Disorder
 Drug: Lithium
Drug: Lamotrigine
Drug: Divalproex
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Combination Therapy in Bipolar Rapid Cycling

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Institute of Mental Health (NIMH):

Estimated Enrollment: 90
Study Start Date: February 2002
Study Completion Date: July 2007
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Detailed Description:

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 7 months. Symptoms of depression and mania will be assessed with scales and patient questionnaires.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00063362

Locations
United States, Ohio
University Hospitals of Cleveland
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Keming Gao, MD, PhD Case Western Reserve University / University Hospitals of Cleveland
  More Information

No publications provided

Responsible Party: Joseph R. Calabrese, University Hospitals Case Medical Center
ClinicalTrials.gov Identifier: NCT00063362     History of Changes
Other Study ID Numbers: R21 MH62650, DSIR AT-SO
Study First Received: June 25, 2003
Last Updated: February 8, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by National Institute of Mental Health (NIMH):
Depression

Additional relevant MeSH terms:
Bipolar Disorder
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Lithium
Lamotrigine
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
 Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Antimanic Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Anticonvulsants

ClinicalTrials.gov processed this record on May 19, 2013