Completed

Vilazodone for Prevention of Corticosteroid-Induced Memory Impairment

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What is being tested

Vilazodone

+ Placebo

+ Hydrocortisone

Drug
Who is being recruted

Nervous System Diseases+3

+ Neurologic Manifestations

+ Signs and Symptoms

From 18 to 50 Years
+11 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Prevention Study

Phase 2
Interventional
Study Start: December 2012
See protocol details

Summary

Principal SponsorUniversity of Texas Southwestern Medical Center
Last updated: April 11, 2019
Sourced from a government-validated database.Claim as a partner

Study start date: December 1, 2012

Actual date on which the first participant was enrolled.

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.

NCT01828515
Principal SponsorUniversity of Texas Southwestern Medical Center
Last updated: April 11, 2019
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

24 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 50 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Nervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsNeurobehavioral ManifestationsMemory Disorders

Criteria

3 inclusion criteria required to participate
BMI between 18.5-30 (not underweight or obese)
Education of >= 12 years and baseline RAVLT total words recalled score >= 35 (normal baseline memory)
Healthy men and women age 18-50 years
8 exclusion criteria prevent from participating
Baseline HRSD (Hamilton Rating Scale for Depression) > 7 or current suicidal ideation or history of suicide attempt
History of allergic reaction or medical contraindication to vilazodone or hydrocortisone
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
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
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 II

Experimental
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.

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

UT Southwestern Medical Center

Dallas, United StatesOpen UT Southwestern Medical Center in Google Maps
CompletedOne Study Center