Vilazodone for Corticosteroid-Induced Memory Impairment
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||Vilazodone for Corticosteroid-Induced Memory Impairment|
- The primary outcome measure will be change in declarative memory as assessed by the RAVLT (Rey Auditory Verbal Learning Test) from baseline. [ Time Frame: 19 days ] [ Designated as safety issue: No ]
- A secondary outcome will be change in mood as measured by the ISS (Internal State Scale) from baseline. [ Time Frame: 19 days ] [ Designated as safety issue: No ]
|Study Start Date:||December 2012|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||June 2014 (Final data collection date for primary outcome measure)|
Active Comparator: Vilazodone
vilazodone titrated to 10 mg x 7 days, 20 mg x 7 days and 40 mg x 5 days (19 days)
Participants will be randomized to either vilazodone or placebo titrated as follows: 10 mg x 7 days, 20 mg x 7 days and 40 mg x 5 days.
Other Name: Viibryd
Placebo Comparator: Placebo
placebo, daily for 19 days
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.
|United States, Texas|
|UT Southwestern Medical Center|
|Dallas, Texas, United States, 75390|
|Principal Investigator:||E. Sherwood Brown, M.D., Ph.D.||UT Southwestern Medical Center|