Vilazodone for Corticosteroid-Induced Memory Impairment



Status:Completed
Conditions:Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - 50
Updated:5/3/2014
Start Date:December 2012
End Date:December 2014
Contact:Kimberly K Anderson, BS
Email:kimberlyk.anderson@utsouthwestern.edu
Phone:2146456954

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The purpose of this study is to examine whether vilazodone attenuates the memory and mood
effects of corticosteroids on the human hippocampus in 18 healthy controls.

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 taking prescription corticosteroids and to patients with major
depressive disorder or bipolar disorder who have elevated cortisol levels and memory
impairment. The investigators believe that vilazodone may be a medication that can block the
effects of hydrocortisone on the human hippocampus. The investigators propose to examine
whether vilazodone attenuates the effects of corticosteroids in a randomized, double-blind,
placebo-controlled pilot study using a within-subject crossover design.

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
We found this trial at
1
site
2201 Inwood Rd
Dallas, Texas 75235
(214) 645-8300
U.T. Southwestern Medical Center The story of UT Southwestern Medical Center is one of commitment...
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Dallas, TX
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