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Vilazodone for Corticosteroid-Induced Memory Impairment

This study has been completed.
Forest Laboratories
Information provided by (Responsible Party):
Sherwood Brown, University of Texas Southwestern Medical Center Identifier:
First received: November 7, 2012
Last updated: March 24, 2015
Last verified: March 2015
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.

Condition Intervention Phase
Memory Impairment Drug: Vilazodone Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Vilazodone for Corticosteroid-Induced Memory Impairment

Resource links provided by NLM:

Further study details as provided by Sherwood Brown, University of Texas Southwestern Medical Center:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • A secondary outcome will be change in mood as measured by the ISS (Internal State Scale) from baseline. [ Time Frame: 19 days ]

Enrollment: 24
Study Start Date: December 2012
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Vilazodone
vilazodone titrated to 10 mg x 7 days, 20 mg x 7 days and 40 mg x 5 days (19 days)
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.
Other Name: Viibryd
Placebo Comparator: Placebo
placebo, daily for 19 days
Drug: Placebo

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.

Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01828515

United States, Texas
UT Southwestern Medical Center
Dallas, Texas, United States, 75390
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Forest Laboratories
Principal Investigator: E. Sherwood Brown, M.D., Ph.D. UT Southwestern Medical Center
  More Information

Responsible Party: Sherwood Brown, Professor, University of Texas Southwestern Medical Center Identifier: NCT01828515     History of Changes
Other Study ID Numbers: 082012-082
Study First Received: November 7, 2012
Last Updated: March 24, 2015

Additional relevant MeSH terms:
Memory Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Vilazodone Hydrochloride
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists processed this record on September 20, 2017