Sensitivity of Short and Long Allele Carriers of the 5-HTTLPR to Environmental Threat Post Hydrocortisone Administration

NCT01710202 | Completed DMC

• 1 other identifier: 2011-12-0017
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 2

Brief Summary

The current study will test the causal relationship between elevated levels of cortisol and the serotonin transporter gene (5-HTTLPR) as these factors influence sensitivity to environmental threat. The investigators predict that carriers of the short allele of the serotonin transporter gene who have elevated cortisol levels will be most sensitive to threatening environments, whereas carriers of the long allele who do not have elevated cortisol (placebo subjects) will be least sensitive.

Conditions

Major Depressive Disorder; Anxiety Disorders

Keywords

Hydrocortisone; Cortisol; Testosterone; Stress; Serotonin; 5-HTTLPR; Amygdala; Depression

Outcome Measures

Primary Outcomes (1)

• Change in testosterone concentration

  Subjects will be administered hydrocortisone or placebo. One hour after administration, they will be exposed to an environmental threat manipulation. 20 minutes after this manipulation, saliva will be collected, and testosterone concentrations will be assessed and compared to pre-manipulation concentrations

  2 hours post hydrocortisone administration

Study Arms (2)

Placebo

Control group who will not receive hydrocortisone. Will act as a comparison group to the hydrocortisone group.

Experimental: Hydrocortisone

Group will receive 20mg oral hydrocortisone

Drug: Hydrocortisone

Interventions

Hydrocortisone DRUG

Each subject in this group will receive one 20mg hydrocortisone capsule to be taken by mouth.

Also known as: Cortef, Cortisol, Hydrocortone

Experimental: Hydrocortisone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

University of Texas at Austin students

You may qualify if:

• None

You may not qualify if:

• Are you under the age of 18 years old?
• Have you ever had an allergic reaction to hydrocortisone?
• Do you have diabetes or high blood pressure?
• Do you have any thyroid, liver, heart, lung, or kidney problems?
• Do you have herpes, HIV or any sexual transmitted disease?
• Are you currently pregnant or think you might be pregnant? Have you taken RU486, Plan B or "Morning After Pill" within the last 2 weeks? - Are you currently breastfeeding?
• Have you been sick within the last week? Do you have any fungal infections?
• Have you been exposed to measles or chicken pox in the last week?
• Have you ever had a seizure?
• Do you have any disease of bony tissue, such as osteoporosis?
• Do you have any autoimmune diseases, such as myasthenia gravis?
• Do you have multiple sclerosis?
• Do you have any condition that compromises you immune system function or causes you to be more likely to get sick?
• Have you had any recent surgeries?
• Do you have and gastrointestinal problems, such as ulcers, diverticulitis, colitis, hepatitis, or Crohn disease?

Sponsors & Collaborators

• University of Texas at Austin: lead

Study Sites (2)

University of Texas at Austin Department of Psychology

Austin, Texas, 78712, United States

Location

University of Texas at Austin

Austin, Texas, 78712, United States

Location

Related Publications (1)

• Josephs RA, Telch MJ, Hixon JG, Evans JJ, Lee H, Knopik VS, McGeary JE, Hariri AR, Beevers CG. Genetic and hormonal sensitivity to threat: testing a serotonin transporter genotype x testosterone interaction. Psychoneuroendocrinology. 2012 Jun;37(6):752-61. doi: 10.1016/j.psyneuen.2011.09.006. Epub 2011 Oct 5.

  PMID: 21978869 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Saliva

MeSH Terms

Conditions

Depressive Disorder, Major; Anxiety Disorders; Depression

Interventions

Hydrocortisone

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; 11-Hydroxycorticosteroids; Hydroxycorticosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; 17-Hydroxycorticosteroids

Study Officials

• Robert A Josephs, Ph.D.

  University of Texas at Austin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2012
• First Posted: October 19, 2012
• Study Start: October 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: November 1, 2014
• Last Updated: March 20, 2015

Record last verified: 2013-08

Locations

US (2)