Vilazodone for Corticosteroid-Induced Memory Impairment

NCT01828515 | Completed Phase 2 Results

• 1 other identifier: 082012-082
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Memory Impairment

Outcome Measures

Primary Outcomes (1)

• Change From Baseline RAVLT (Rey Auditory Verbal Learning Test) Total T-Score at 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.

  Baseline and Day 19

Study Arms (2)

Vilazodone and Hydrocortisone, then Placebo and Hydrocortisone

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.

Drug: Vilazodone; Drug: Placebo; Drug: Hydrocortisone

Placebo and Hydrocortisone, then Vilazodone and Hydrocortisone

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.

Drug: Vilazodone; Drug: Placebo; Drug: Hydrocortisone

Interventions

Vilazodone 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.

Also known as: Viibryd

Placebo and Hydrocortisone, then Vilazodone and Hydrocortisone; Vilazodone and Hydrocortisone, then Placebo and Hydrocortisone

Placebo DRUG

Placebo and Hydrocortisone, then Vilazodone and Hydrocortisone; Vilazodone and Hydrocortisone, then Placebo and Hydrocortisone

Hydrocortisone DRUG

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

Placebo and Hydrocortisone, then Vilazodone and Hydrocortisone; Vilazodone and Hydrocortisone, then Placebo and Hydrocortisone

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• Forest Laboratories: collaborator

Study Sites (1)

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Memory Disorders

Interventions

Vilazodone Hydrochloride; Hydrocortisone

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indoles; Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; 11-Hydroxycorticosteroids; Hydroxycorticosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; 17-Hydroxycorticosteroids

Limitations and Caveats

The sample size was modest and attrition rate was high; The study also lacked neuroimaging or other biomarkers to correlate changes in memory; Study drug adherence was only assessed with pill counts not with metered dosing counts or blood levels.

Results Point of Contact

• Title: Dr. E. Sherwood Brown
• Organization: UT Southwestern Medical Center

sherwood.brown@utsouthwestern.edu

214-645-6950

Study Officials

• E. Sherwood Brown, M.D., Ph.D.

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 7, 2012
• First Posted: April 10, 2013
• Study Start: December 1, 2012
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: April 11, 2019
• Results First Posted: July 5, 2018

Record last verified: 2019-03

Locations

US (1)