Trials / Completed
CompletedNCT01828515
Vilazodone for Corticosteroid-Induced Memory Impairment
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 24 (actual)
- Sponsor
- University of Texas Southwestern Medical Center · Academic / Other
- Sex
- All
- Age
- 18 Years – 50 Years
- Healthy volunteers
- Accepted
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 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Vilazodone | 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. |
| DRUG | Placebo | |
| DRUG | Hydrocortisone | Participants receive 160 mg x 4 days after vilazodone or placebo pre-treatment |
Timeline
- Start date
- 2012-12-01
- Primary completion
- 2014-04-01
- Completion
- 2014-04-01
- First posted
- 2013-04-10
- Last updated
- 2019-04-11
- Results posted
- 2018-07-05
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01828515. Inclusion in this directory is not an endorsement.