Major Depressive Disorder Clinical Trial
— 5-HTTLPROfficial title:
Sensitivity of Short and Long Allele Carriers of the 5-HTTLPR to Environmental Threat Post Hydrocortisone Administration
Verified date | August 2013 |
Source | University of Texas at Austin |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Observational |
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.
Status | Completed |
Enrollment | 120 |
Est. completion date | November 2014 |
Est. primary completion date | December 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: Exclusion Criteria: - 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? - Are you taking any of the following medications: nevirapine, telbivudine, sipuleucel-T (IV), natalizumab (IV)? - Have you received any vaccinations within the last week? - With the exception of vitamins, have you taken any medications in the last 3 days, including all over-the counter medications and/or supplements (e,g. Tylenol, ibuprofen, St. John's Wort, cold remedies)? - Do you currently have or have you had in the past of any kind of cancer? - Do you have any significant medical or psychiatric illnesses not listed above? |
Observational Model: Case Control
Country | Name | City | State |
---|---|---|---|
United States | University of Texas at Austin | Austin | Texas |
United States | University of Texas at Austin Department of Psychology | Austin | Texas |
Lead Sponsor | Collaborator |
---|---|
University of Texas at Austin |
United States,
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 × testosterone interaction. Psychoneuroendocrinology. 2012 Jun;37(6):752-61. doi: 10.1016/j.psyneuen.2011.09.006. Epub 2011 Oct 5. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
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