Phase 4
Completed N=28
Clinical Trial of Lamotrigine to Reverse Cognitive Impairment in Chronic Corticosteroid-Treated Patients
Memory Impairment Due to Corticosteroid Use · Hypomania Due to Corticosteroid Use · Hippocampal Atrophy Due to Corticosteroid
Source: ClinicalTrials.gov NCT00223262 ↗
Enrolled (actual)
28
Serious AEs
0.0%
Results posted
Apr 2019
Primary outcomePrimary: Rey Auditory Verbal Learning Test (RAVLT) — 46.1; 40.1 T-scores
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rey Auditory Verbal Learning Test (RAVLT) |
46.1; 40.1 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00223262). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.