Back to resultsVilazodone for Corticosteroid-Induced Memory Impairment
Primary Purpose
Memory Impairment
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Vilazodone
Placebo
Hydrocortisone
Sponsored by
About this trial
This is an interventional prevention trial for Memory Impairment
Eligibility 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
Sites / Locations
- UT Southwestern Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Vilazodone and Hydrocortisone, then Placebo and Hydrocortisone
Placebo and Hydrocortisone, then Vilazodone and Hydrocortisone
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Change From Baseline RAVLT (Rey Auditory Verbal Learning Test) Total T-Score at 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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01828515
First Posted
November 7, 2012
Last Updated
March 29, 2019
Sponsor
University of Texas Southwestern Medical Center
Collaborators
Forest Laboratories
1. Study Identification
Unique Protocol Identification Number
NCT01828515
Brief Title
Vilazodone for Corticosteroid-Induced Memory Impairment
Official Title
Vilazodone for Corticosteroid-Induced Memory Impairment
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
April 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas Southwestern Medical Center
Collaborators
Forest Laboratories
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Memory Impairment
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vilazodone and Hydrocortisone, then Placebo and Hydrocortisone
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo and Hydrocortisone, then Vilazodone and Hydrocortisone
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Vilazodone
Other Intervention Name(s)
Viibryd
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Type
Drug
Intervention Name(s)
Hydrocortisone
Intervention Description
Participants receive 160 mg x 4 days after vilazodone or placebo pre-treatment
Primary Outcome Measure Information:
Title
Change From Baseline RAVLT (Rey Auditory Verbal Learning Test) Total T-Score at Day 19
Description
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.
Time Frame
Baseline and Day 19
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
E. Sherwood Brown, M.D., Ph.D.
Organizational Affiliation
UT Southwestern Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
UT Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Vilazodone for Corticosteroid-Induced Memory Impairment
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