Vilazodone for Corticosteroid-Induced Memory Impairment

The University of Texas System (UT)

Status and phase: Completed; Phase 2

Conditions: Memory Impairment

Treatments: Drug: Vilazodone; Drug: Hydrocortisone; Drug: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01828515

082012-082

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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24 participants in 2 patient groups

Vilazodone and Hydrocortisone, then Placebo and Hydrocortisone

Experimental group

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.

Treatment:

Drug: Vilazodone

Drug: Hydrocortisone

Drug: Placebo

Placebo and Hydrocortisone, then Vilazodone and Hydrocortisone

Experimental group

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.

Treatment:

Drug: Vilazodone

Drug: Hydrocortisone

Drug: Placebo