CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 28 enrolled
Drug / intervention
Lamotrigine (Drug)drug
Likely dose
Not stated in record
Key inclusion· 2
  • Current corticosteroid use of 7 mg or more daily for at least 6 months
  • Age 18-65 years
Key exclusion· 7
  • Currently taking Depakote (valproate)
  • Currently taking Rifampin
  • Diagnosis of major depressive disorder, schizophrenia, PTSD, or bipolar I/II disorder not related to corticosteroid use
  • Diseases with CNS involvement

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00223262
NCT00223262Phase 4Completed

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

University of Texas Southwestern Medical Center·interventional·Posted Sep 22, 2005·Updated Apr 16, 2019

In Brief

A Phase 4 clinical trial evaluating Lamotrigine (Drug) for Memory Impairment Due to Corticosteroid Use and 2 related conditions. Completed, enrolled 28 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 22, 2005
Enrollment StartAug 1, 2002
Primary CompletionSep 1, 2005
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 20.8 years ago

Interventions

Lamotrigine (Drug)drug