Status:
COMPLETED
Vilazodone for Corticosteroid-Induced Memory Impairment
Lead Sponsor:
University of Texas Southwestern Medical Center
Collaborating Sponsors:
Forest Laboratories
Conditions:
Memory Impairment
Eligibility:
All Genders
18-50 years
Phase:
PHASE2
Brief 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.
Detailed Description
In animals and humans, stress and corticosteroid excess are associated with changes in hippocampal structure and functioning. These findings have important implications to the millions of patients tak...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2014
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01828515
Start Date
December 1 2012
End Date
April 1 2014
Last Update
April 11 2019
Active Locations (1)
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1
UT Southwestern Medical Center
Dallas, Texas, United States, 75390