Vilazodone for Corticosteroid-Induced Memory Impairment

NCT ID: NCT01828515

Last Updated: 2019-04-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-31
• Study Completion Date: 2014-04-30

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.

Conditions

Memory Impairment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Vilazodone

Intervention Type: DRUG

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.

Placebo

Intervention Type: DRUG

Hydrocortisone

Intervention Type: DRUG

Participants receive 160 mg x 4 days after vilazodone or placebo pre-treatment

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.

Group Type: EXPERIMENTAL

Vilazodone

Intervention Type: DRUG

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.

Placebo

Intervention Type: DRUG

Hydrocortisone

Intervention Type: DRUG

Participants receive 160 mg x 4 days after vilazodone or placebo pre-treatment

Interventions

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.

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Hydrocortisone

Participants receive 160 mg x 4 days after vilazodone or placebo pre-treatment

Intervention Type: DRUG

Other Intervention Names

Viibryd

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Forest Laboratories

INDUSTRY

Sponsor Role: collaborator

University of Texas Southwestern Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Sherwood Brown, MD, PhD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

E. Sherwood Brown, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

UT Southwestern Medical Center

Locations

UT Southwestern Medical Center

Dallas, Texas, United States

Countries

United States

Other Identifiers

082012-082

Identifier Type: -

Identifier Source: org_study_id