Phase 2
Completed N=24
Vilazodone for Corticosteroid-Induced Memory Impairment
Source: ClinicalTrials.gov NCT01828515 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Jul 2018
Primary outcomePrimary: Change From Baseline RAVLT (Rey Auditory Verbal Learning Test) Total T-Score at Day 19 — -3; 0 T-score
Summary
The purpose of this study is to examine whether vilazodone attenuates the memory and mood effects of corticosteroids on the human hippocampus in 24 healthy controls.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline RAVLT (Rey Auditory Verbal Learning Test) Total T-Score at Day 19 |
-3; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Healthy men and women age 18-50 years
- Education of ≥ 12 years and baseline RAVLT total words recalled score ≥ 35 (normal baseline memory)
- BMI between 18.5-30 (not underweight or obese)
Exclusion Criteria
- History of major psychiatric illness defined as major depressive disorder, bipolar disorder, posttraumatic stress disorder, panic disorder, schizoaffective disorder, schizophrenia, eating disorders, or drug/alcohol abuse/dependence or current tobacco use
- History of neurological disorders including seizures, brain surgery, multiple sclerosis, Parkinson's disease
- Taking CNS-acting medications within 30 days of study
- History of allergic reaction or medical contraindication to vilazodone or hydrocortisone
- Significant medical conditions (e.g., myocardial infarction, cancer, diabetes)
- Vulnerable population including pregnant or nursing women, the incarcerated, and severe cognitive disorders
- Baseline HRSD (Hamilton Rating Scale for Depression) > 7 or current suicidal ideation or history of suicide attempt
- History of systemic Corticosteroid (CS) use or recent (past 6 months) inhaled CS use
Data sourced from ClinicalTrials.gov (NCT01828515). 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.