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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.
 
ClinicalTrials.gov Identifier: NCT01828515
Recruitment Status : Completed
First Posted : April 10, 2013
Results First Posted : July 5, 2018
Last Update Posted : April 11, 2019
Sponsor:
Collaborator:
Forest Laboratories
Information provided by (Responsible Party):
Sherwood Brown, MD, PhD, 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 24 healthy controls.

Condition or disease Intervention/treatment Phase
Memory Impairment Drug: Vilazodone Drug: Placebo Drug: Hydrocortisone 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.

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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


Arm Intervention/treatment
Experimental: Vilazodone and Hydrocortisone, then Placebo and Hydrocortisone
Vilazodone titrated to 10 mg x 7 days, 20 mg x 7 days and 40 mg x 5 days (19 days) and hydrocortisone 160 mg x 4 days (days 16-19) following vilazodone pre-treatment. After a 23 day medication washout the procedure will be repeated using placebo daily for 19 days and hydrocortisone 160 mg x 4 days (days 16-19) following placebo pre-treatment.
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

Drug: Placebo
Drug: Hydrocortisone
Participants receive 160 mg x 4 days after vilazodone or placebo pre-treatment

Experimental: Placebo and Hydrocortisone, then Vilazodone and Hydrocortisone
Placebo daily for 19 days and hydrocortisone 160 mg x 4 days (days 16-19) following placebo pre-treatment. After a 23 day medication washout the procedure will be repeated using Vilazodone titrated to 10 mg x 7 days, 20 mg x 7 days and 40 mg x 5 days (19 days) and hydrocortisone 160 mg x 4 days (days 16-19) following vilazodone pre-treatment.
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

Drug: Placebo
Drug: Hydrocortisone
Participants receive 160 mg x 4 days after vilazodone or placebo pre-treatment




Primary Outcome Measures :
  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.



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

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 ClinicalTrials.gov identifier (NCT number): NCT01828515


Locations
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United States, Texas
UT Southwestern Medical Center
Dallas, Texas, United States, 75390
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Forest Laboratories
Investigators
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Principal Investigator: E. Sherwood Brown, M.D., Ph.D. UT Southwestern Medical Center
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Responsible Party: Sherwood Brown, MD, PhD, Professor, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT01828515    
Other Study ID Numbers: 082012-082
First Posted: April 10, 2013    Key Record Dates
Results First Posted: July 5, 2018
Last Update Posted: April 11, 2019
Last Verified: March 2019
Additional relevant MeSH terms:
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Memory Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Hydrocortisone
Vilazodone Hydrochloride
Anti-Inflammatory Agents
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