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

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ClinicalTrials.gov Identifier: NCT00223262
Recruitment Status : Completed
First Posted : September 22, 2005
Results First Posted : April 15, 2019
Last Update Posted : April 15, 2019
Sponsor:
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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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




Primary Outcome Measures :
  1. Rey Auditory Verbal Learning Test (RAVLT) [ Time Frame: 24 weeks ]
    Rey Auditory Verbal Learning Test (RAVLT) is a test of verbal learning and declarative memory. During the test, 15 nouns that are read aloud for 5 consecutive trials. Each trial is followed by a free recall test (participant is asked to recall the words that were just read to them). The sum of correctly recalled words across 5 trials is called the total raw score. On completion of Trial 5, an interference list of 15 words (List B) is presented, followed by a free recall test of that list. After a 20-min delay, the examinee is again required to recall the words from list A - this is called the delay raw score. The raw scores on both the total recall and the delay trials (number of words correct across trials 1-5) are converted to standardized T-scores (Mean=50; SD=10; range 20-100) based on participant age and gender. The scores below are presented as T-scores, with higher scores indicative of better performance.



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

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 ClinicalTrials.gov identifier (NCT number): NCT00223262


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

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Responsible Party: Sherwood Brown, UT Southwestern Medical Center at Dallas
ClinicalTrials.gov Identifier: NCT00223262     History of Changes
Other Study ID Numbers: LMC-R62
First Posted: September 22, 2005    Key Record Dates
Results First Posted: April 15, 2019
Last Update Posted: April 15, 2019
Last Verified: April 2019
Additional relevant MeSH terms:
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Atrophy
Pathological Conditions, Anatomical
Lamotrigine
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Sodium Channel Blockers