Vilazodone for Corticosteroid-Induced Memory Impairment
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ClinicalTrials.gov Identifier: NCT01828515 |
Recruitment Status :
Completed
First Posted : April 10, 2013
Results First Posted : July 5, 2018
Last Update Posted : April 11, 2019
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Condition or disease | Intervention/treatment | Phase |
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Memory Impairment | Drug: Vilazodone Drug: Placebo Drug: Hydrocortisone | Phase 2 |
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 |
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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.
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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.
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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 |
- 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 |
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

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
United States, Texas | |
UT Southwestern Medical Center | |
Dallas, Texas, United States, 75390 |
Principal Investigator: | E. Sherwood Brown, M.D., Ph.D. | UT Southwestern Medical Center |
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 |
Memory Disorders Neurobehavioral Manifestations Neurologic Manifestations Nervous System Diseases 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 |