Vilazodone for Corticosteroid-Induced Memory Impairment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01828515
Recruitment Status : Completed
First Posted : April 10, 2013
Last Update Posted : March 26, 2015
Forest Laboratories
Information provided by (Responsible Party):
Sherwood Brown, University of Texas Southwestern Medical Center

Brief Summary:
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 or disease Intervention/treatment Phase
Memory Impairment Drug: Vilazodone Drug: Placebo Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Vilazodone for Corticosteroid-Induced Memory Impairment
Study Start Date : December 2012
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Memory Steroids

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 :
  1. A secondary outcome will be change in mood as measured by the ISS (Internal State Scale) from baseline. [ Time Frame: 19 days ]

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Responsible Party: Sherwood Brown, Professor, University of Texas Southwestern Medical Center Identifier: NCT01828515     History of Changes
Other Study ID Numbers: 082012-082
First Posted: April 10, 2013    Key Record Dates
Last Update Posted: March 26, 2015
Last Verified: March 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