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

This study has been completed.
Sponsor:
Information provided by:
University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT00223262
First received: September 15, 2005
Last updated: August 2, 2011
Last verified: January 2010
  Purpose

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 Intervention 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
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind

Resource links provided by NLM:


Further study details as provided by University of Texas Southwestern Medical Center:

Study Start Date: August 2002
Study Completion Date: September 2005
Primary Completion Date: September 2005 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00223262

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

No publications provided

Responsible Party: Sherwood Brown, UT Southwestern Medical Center at Dallas
ClinicalTrials.gov Identifier: NCT00223262     History of Changes
Other Study ID Numbers: LMC-R62
Study First Received: September 15, 2005
Last Updated: August 2, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Lamotrigine
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers

ClinicalTrials.gov processed this record on September 18, 2014