Clinical Trial of Lamotrigine to Reverse Cognitive Impairment in Chronic Corticosteroid-Treated Patients

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: NCT00223262
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : August 3, 2011
Information provided by:
University of Texas Southwestern Medical Center

Brief Summary:
The purpose of this study is to determine if lamotrigine therapy is associated with improvement in mood, memory and hippocampal size and function in patients receiving chronic corticosteroid therapy. Standard care for mood changes associated with corticosteroid therapy, if severe, includes antidepressants or other medications which can influence mood. No therapies, other than dose reduction or discontinuation, are currently available for memory loss associated with corticosteroid treatment. However, very little information is available on the treatment of either mood or memory changes associated with corticosteroid treatment, thus the proposed project may improve standard care.

Condition or disease Intervention/treatment Phase
Memory Impairment Due to Corticosteroid Use. Hypomania Due to Corticosteroid Use. Hippocampal Atrophy Due to Corticosteroid. Drug: Lamotrigine (Drug) Phase 4

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Study Start Date : August 2002
Actual Primary Completion Date : September 2005
Actual Study Completion Date : September 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Steroids
Drug Information available for: Lamotrigine
U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All

Inclusion Criteria:

  • Current Corticosteroid Use of 7 mg or more for 6+ months
  • 18-65 years of age

Exclusion Criteria:

  • Primarily non-English speaking
  • Pregnant/nursing woman
  • Currently taking Depakote
  • Currently taking Rifampin
  • Has diagnosis of major depressive disorder, schizophrenia, PTSD, bipolar I or bipolar II (not related to corticosteroid use)
  • Diseases with CNS involvement
  • Is to start a brief steroid taper
  • History of Alcohol/drug abuse/dependence

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): NCT00223262

United States, Texas
The UT Southwestern Medical Center
Dallas, Texas, United States, 75390-8843
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Principal Investigator: E. Sherwood Brown, Ph.D., M.D. The UT Southwestern Medical Center

Responsible Party: Sherwood Brown, UT Southwestern Medical Center at Dallas Identifier: NCT00223262     History of Changes
Other Study ID Numbers: LMC-R62
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: August 3, 2011
Last Verified: January 2010

Additional relevant MeSH terms:
Pathological Conditions, Anatomical
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers