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Completed

NCT Number: NCT01828515

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 24 healthy controls.

Completed

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vilazodone

Drug

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 names: Viibryd

Placebo

Drug

Hydrocortisone

Drug

Participants receive 160 mg x 4 days after vilazodone or placebo pre-treatment

Primary outcomes

  1. Change From Baseline RAVLT (Rey Auditory Verbal Learning Test) Total T-Score at Day 19

    Time frame: Baseline and Day 19

    The Rey Auditory Verbal Learning Test (RAVLT) measures verbal or declarative learning and memory. The test consists of 15 nouns read aloud for five consecutive trials with each trial followed by a free-recall trial. Following the fifth trial, an interference list of 15 different words is presented followed by a free-recall trial of that list. Delayed recall of the first list is tested immediately following the interference list and after a 20-minute delay. Equivalent, alternative versions (different words) were used to minimize practice or learning effects from repeated administration. The raw scores (number of words correct across trials 1-5) are converted to standardized T-scores (M=50; SD=10). This score is used to determine the participant's performance in relation to norm-referenced expectations based on age and sex. Higher score reflects better performance, and the values reflect scores at baseline minus the scores at Day 19.

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Collaborators

  • Forest Laboratories

Registry information

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Apr 10, 2013
Registry last updated
Apr 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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