Vilazodone for Corticosteroid-Induced Memory Impairment

• Status: Completed
• Trial end date: 2014-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Texas Southwestern Medical Center
• Collaborator: Forest Laboratories
• Treatments: Hydrocortisone; Vilazodone Hydrochloride

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