- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00223262
Clinical Trial of Lamotrigine to Reverse Cognitive Impairment in Chronic Corticosteroid-Treated Patients
April 12, 2019 updated by: University of Texas Southwestern Medical Center
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
28
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Texas
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Dallas, Texas, United States, 75390-8843
- The UT Southwestern Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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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24 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: E. Sherwood Brown, Ph.D., M.D., The UT Southwestern Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2002
Primary Completion (ACTUAL)
September 1, 2005
Study Completion (ACTUAL)
September 1, 2005
Study Registration Dates
First Submitted
September 15, 2005
First Submitted That Met QC Criteria
September 15, 2005
First Posted (ESTIMATE)
September 22, 2005
Study Record Updates
Last Update Posted (ACTUAL)
April 16, 2019
Last Update Submitted That Met QC Criteria
April 12, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nervous System Diseases
- Neurologic Manifestations
- Neurobehavioral Manifestations
- Mania
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Antipsychotic Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Membrane Transport Modulators
- Anticonvulsants
- Sodium Channel Blockers
- Calcium-Regulating Hormones and Agents
- Calcium Channel Blockers
- Lamotrigine
Other Study ID Numbers
- LMC-R62
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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