- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01710202
Sensitivity of Short and Long Allele Carriers of the 5-HTTLPR to Environmental Threat Post Hydrocortisone Administration (5-HTTLPR)
March 18, 2015 updated by: University of Texas at Austin
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Depression vulnerability has been linked to certain variants of the serotonin transporter gene.
Research indicates that a polymorphism of the serotonin transporter (5-HTTLPR) gene appears to moderate the association between life stress and depression onset.
Life stress robustly predicts depression onset for individuals with two short 5-HTTLPR alleles.
Individuals homozygous for the short 5-HTTLPR allele thus appear to be more sensitive to the effect of life stress, which in turn contributes to depression onset.
A recent study showed that short allele carriers presented with a threat (social or other threats) who also had high levels of testosterone had elevated cortisol after exposure to the threat.
There is neurobiological evidence that short allele status, elevated testosterone levels, and elevated cortisol levels are all linked to amygdala hyper-reactivity to the same classes of environmental threats.
Thus, this study will test, for the first time, a potential interaction between 5-HTTLPR status and experimentally manipulated cortisol levels as risk factors for downstream mood and/or anxiety disorders by examining potential dysregulated stress responses among short allele carriers who have elevated cortisol levels.
Study Type
Observational
Enrollment (Actual)
120
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Texas
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Austin, Texas, United States, 78712
- University of Texas at Austin
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Austin, Texas, United States, 78712
- University of Texas at Austin Department of Psychology
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
University of Texas at Austin students
Description
Inclusion Criteria:
- None
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?
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Placebo
Control group who will not receive hydrocortisone.
Will act as a comparison group to the hydrocortisone group.
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Experimental: Hydrocortisone
Group will receive 20mg oral hydrocortisone
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Each subject in this group will receive one 20mg hydrocortisone capsule to be taken by mouth.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in testosterone concentration
Time Frame: 2 hours post hydrocortisone administration
|
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
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2 hours post hydrocortisone administration
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Robert A Josephs, Ph.D., University of Texas at Austin
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2012
Primary Completion (ACTUAL)
December 1, 2013
Study Completion (ACTUAL)
November 1, 2014
Study Registration Dates
First Submitted
October 16, 2012
First Submitted That Met QC Criteria
October 18, 2012
First Posted (ESTIMATE)
October 19, 2012
Study Record Updates
Last Update Posted (ESTIMATE)
March 20, 2015
Last Update Submitted That Met QC Criteria
March 18, 2015
Last Verified
August 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2011-12-0017
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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