Is this study a clinical trial?
No, this study is not a clinical trial. A clinical trial is a study that tests the safety and efficacy of a new treatment (drug, device, or therapy). We are not testing hydrocortisone or dexamethasone (the drugs used in this study) as treatments for depression. They are being used to manipulate hormone levels in your body so that we can learn more about how the hormones work in women with and without depression. It is our hope that study results will contribute to the development of new treatments for depression in the future.
What if I don’t know if I’m depressed?
It is okay if you don’t know whether you are experiencing depression. You don’t need to have a depression diagnosis to participate in this study. We are enrolling both women who are currently experiencing depression and women who are not experiencing depression. We will assess your symptoms during the phone screening, and you will meet with a clinical interviewer during the screening session who will determine if you have depression. If you’d like to learn more about the symptoms of depression, please click here.
What are “adverse childhood events”?
For this study, we are recruiting women who have experienced adverse childhood events. We are also recruiting a comparison group of women who have not experienced adverse childhood events. The following events experienced before age 18 may qualify as adverse childhood events:
- Parental divorce or separation
- Death of a parent or childhood guardian
- Traumatic sexual experience
- Abuse or neglect
- Victim of violence
- Other traumatic experience
Are the visit times flexible?
Some of the visit times are flexible, while others are not. Most of the visits must occur in the late afternoon/early evening. Please read the detailed study description for more information about visit times, and feel free to contact the Study Coordinator if you have any questions.
What is cortisol?
Cortisol is a steroid hormone that your body produces naturally. It is secreted by the adrenal gland. Your body releases cortisol in response to daily events, such as waking up in the morning, eating, and exercising. Due to its involvement in the “fight-or-flight” response, cortisol is best known for its role as a “stress hormone”. Along with other stress-related hormones, cortisol temporarily increases the availability of energy stores to help your body deal with stressors.
What is hydrocortisone?
Hydrocortisone is the synthetic (or man-made) version of the hormone cortisol. It is available in many over-the-counter and prescription products, such as topical creams, tablets, and injections, which are used to treat a number of medical problems. Topical creams reduce swelling, itching, and redness due to skin conditions, such as insect bites, eczema, allergies, and rashes. Hydrocortisone is also used to treat allergic reactions; certain forms of arthritis; skin, blood, kidney, eye, thyroid, and intestinal disorders; severe allergies; and asthma.
In this study, participants take a pill containing a low dose of hydrocortisone (up to 20 mg) during one of the fMRI scanning sessions. During the other scanning session, participants take a placebo pill (which contains a sugar-like substance). The dose of hydrocortisone used in this study raises the level of cortisol in your body about as much as vigorously riding an exercise bike for 30 minutes or speaking in public.
Are there any side effects associated with hydrocortisone?
The dose of hydrocortisone used in this study is very low (20 mg) and will not raise cortisol levels higher than what your body naturally produces. The side effects from the oral hydrocortisone used at the study dose are expected to be minimal. At higher doses than used in the study hydrocortisone can cause medical or psychological side effects, such as elevation of blood pressure or effects on mood. However, the dose used in this study has not been reported to produce these effects. Individuals who have a rare hypersensitivity to hydrocortisone may experience a negative reaction to drug administration. If this were to happen, the experiment would be terminated and medical assistance would be sought. Additionally, participants should not receive chicken pox or measles vaccines while participating in this study due to a possible interaction between the vaccines and the hydrocortisone. There are no known long-term side effects of a single dose of hydrocortisone.
What is dexamethasone?
Dexamethasone is a prescription medication that is similar to cortisol. It comes in many forms, such as tablets, eye drops, ear drops, oral liquids, and injections. It is used to treat a number of medical conditions, including allergies, asthma, skin conditions, hormonal disorders, and inflammatory disorders.
In this study, participants take a pill containing a low dose of dexamethasone (0.25 mg) at bedtime on one of the Home Saliva Collection days to test how efficiently their body regulates the hormone cortisol.
Are there any side effects associated with dexamethasone?
There are few side effects associated with the single low dose of dexamethasone used in this study, and significant side effects are not expected. However, mild side effects may occur, such as mood changes, increased sweating, headache, dizziness, nausea, stomach pain, or bloating.