Major Depressive Disorder5-HTTLPRNCT01710202
Sensitivity of Short and Long Allele Carriers of the 5-HTTLPR to Environmental Threat Post Hydrocortisone Administration
An observational study of Major Depressive Disorder and Anxiety Disorders, run by University of Texas at Austin at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorder, Anxiety Disorders
- What is being tested?
- Hydrocortisone
- Type of treatment
- Pill or oral medicine
- How many people
- 120 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2012to Nov 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: University of Texas at Austin students
Who may be able to join
- None
Who cannot join
- 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?
Show all 20Show fewer
- 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?
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Texas at Austin Department of Psychology
Austin, Texas, 78712
University of Texas at Austin
Austin, Texas, 78712
About this study
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.
Read the 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.
- Conditions
- Major Depressive Disorder, Anxiety Disorders
- Being tested
- Hydrocortisone
- Keywords
- Hydrocortisone, Cortisol, Testosterone, Stress, Serotonin, 5-HTTLPR, Amygdala, Depression
- Medical subject headings
- Depressive Disorder, Major, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HydrocortisoneDrug
Also called Cortef, Cortisol, Hydrocortone
Each subject in this group will receive one 20mg hydrocortisone capsule to be taken by mouth.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Hydrocortisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 hours post hydrocortisone administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2012 (estimated)
- Study startOct 2012
- Primary completionDec 2013
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by University of Texas at AustinThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert A Josephs, Ph.D., Principal investigator, University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01710202
- Sponsor's protocol ID
- 2011-12-0017
- Acronym
- 5-HTTLPR
- Status last verified
- Aug 2013
- First submitted
- 16 Oct 2012
- Last updated
- 20 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 21978869
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensitivity of Short and Long Allele Carriers of the 5-HTTLPR to Environmental Threat Post Hydrocortisone Administration
- ClinicalTrials.gov ID
- NCT01710202
- Acronym / sponsor ID
- 5-HTTLPR / 2011-12-0017
- Conditions
- Major Depressive Disorder, Anxiety Disorders
- Keywords
- Hydrocortisone, Cortisol, Testosterone, Stress, Serotonin, 5-HTTLPR, Amygdala, Depression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 19 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | – | –Control group who will not receive hydrocortisone. Will act as a comparison group to the hydrocortisone group. |
| Experimental: Hydrocortisone | – | Drug: HydrocortisoneGroup will receive 20mg oral hydrocortisone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- University of Texas at Austin students
Key inclusion criteria (1 listed)
- None
Key exclusion criteria (20 listed)
- 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?
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HydrocortisoneAlso: Cortef, Cortisol, HydrocortoneEach subject in this group will receive one 20mg hydrocortisone capsule to be taken by mouth. | Drug | Experimental: Hydrocortisone |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2015.
- Background: PubMed 21978869Josephs 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert A Josephs, Ph.D. principal investigator
University of Texas at Austin
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Major Depressive Disorder and Anxiety Disorders, run by University of Texas at Austin at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in testosterone concentration (time frame: 2 hours post hydrocortisone administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01710202, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2015.