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NCT00223262 · ClinicalTrials.gov registry record · Phase 4
Clinical Trial of Lamotrigine to Reverse Cognitive Impairment in Chronic Corticosteroid-Treated Patients
A Phase 4 study, sponsored by University of Texas Southwestern Medical Center.
- Completed
- Registry status
- Phase 4
- Development phase
- 28
- Enrollment target
NCT00223262: Completed Phase 4 study, sponsored by University of Texas Southwestern Medical Center.
NCT00223262 is a Phase 4 study that has completed, run by University of Texas Southwestern Medical Center. The registered enrollment target is 28 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00223262, a Phase 4 study, has completed, sponsored by University of Texas Southwestern Medical Center.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 28 participants
- Enrollment target
Study 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.
Primary Outcome
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
Interventions
- DRUG Lamotrigine (Drug)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2002-08 |
| Est. Completion | 2005-09 |
| Phase | Phase 4 |
What the finished NCT00223262 record still lists
NCT00223262 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 1 intervention - of which Lamotrigine (Drug) is the first listed.
NCT00223262 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00223262 about?
NCT00223262 is a clinical study titled "Clinical Trial of Lamotrigine to Reverse Cognitive Impairment in Chronic Corticosteroid-Treated Patients". 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 antidepre...
What is the current status of trial NCT00223262?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 28 participants. The study started on 2002-08. Estimated completion is 2005-09.
What interventions are being tested in trial NCT00223262?
The interventions under investigation include: Lamotrigine (Drug) (DRUG).
Who is sponsoring clinical trial NCT00223262?
This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00223262's enrollment target sits among peer trials
28 1635th of 2000 higher than 350 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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