Depression, Adversity, and Stress Hormones (DASH) Study (DASH)
Depression
About this trial
This is an interventional basic science trial for Depression focused on measuring Depression, Childhood Adversity, Childhood Abuse, Cortisol, Emotional Memory, Magnetic Resonance Imaging (MRI)
Eligibility Criteria
Inclusion Criteria:
- Female
- 18 to 45 years of age
- English fluency
- Able to lie still on their back for up to 90 minutes
- Willing and able to return for all visits
- Able to provide written informed consent prior to participation
- In good physical health as determined on basis of medical history
- If a nicotine user, able to refrain from nicotine use for 2 hours prior to fMRI scanning and throughout the scan visits
- Additional criteria for never-depressed participants: Free of current or past Diagnostic and Statistical Manual (DSM) IV diagnoses of Major Depressive Disorder (MDD), Dysthymia, or other Depressive Disorder. Never-depressed participants may have past or current psychopathology other than depressive disorders that does not cause significant impairment in functioning and that would not interfere with study participation, be exacerbated by study participation, or introduce scientific difficulties, for example, history of complicated bereavement or history of time-limited alcohol abuse that does not represent a lasting substance use disorder
- Additional criteria for participants with MDD: Meet DSM-IV criteria for MDD (single or recurrent) as determined by a Structured Clinical Interview for DSM-IV (SCID)
Additional criteria for depression-prone participants: Does not meet criteria for current MDD, but meets at least one of the following requirements:
- Meets DSM-IV criteria for past MDD (single or recurrent) as determined by a SCID interview
- Meets DSM-IV criteria for Depressive Disorder Not Otherwise Specified (NOS)
- Meets DSM-IV criteria for Dysthymia
- Has a Beck Depression Inventory (BDI) score of 14 or higher
Exclusion Criteria:
- Current use of any anti-depressant or psychotropic medication while participating in Visits 1-6 and Home Saliva Collection; treatment with electroconvulsive therapy (ECT) within the past 3 months; use of any anti-depressant within 14 days of participation, fluoxetine within 30 days of participation, or any other psychotropic drug within a timeframe based on the half-life of the particular drug
- Using hormonal contraceptives while participating in Visits 1-6 and Home Saliva Collection
- Using any medication that affects central nervous system (CNS) function for 2-4 weeks prior to testing and during participation in Visits 1-6 and Home Saliva Collection
- Using any illicit drug for 4 weeks prior to testing and during participation in Visits 1-6 and Home Saliva Collection
- Using any steroid, anti-histamine, nasal spray (which includes corticosteroids), or topical hydrocortisone cream/gel that affects the hypothalamic-pituitary-adrenal (HPA) axis for 2-4 weeks prior to testing and throughout the duration of the study
- History of seizures, diabetes, hypertension, neurological problems, and/or cardiac problems
- Metallic implants (i.e., prostheses, shrapnel, or aneurysm clips) or electronic implants (i.e., cardiac pacemakers) that are contraindicated for MRI
- Any clinically significant abnormalities on medical history or physical exam
- Currently pregnant, trying to become pregnant, breastfeeding, within a six-month window following pregnancy or breastfeeding, sexually active without an acceptable method of birth control (e.g., abstinence, male vasectomy, female sterilization, condom)
- Post-menopausal and peri-menopausal women
- Women with highly irregular menstrual cycles (e.g., more than 60 days between periods or less than 14 days between periods)
- Individuals who work the "night shift" (e.g., between the hours of 11 pm and 7 am) will be excluded due to potential variability in cortisol levels determined by sleep schedule
- Heavy nicotine user (e.g., smokes more than a pack/day)
- Unable to fit comfortably in the MRI simulator and/or scanner (e.g., BMI greater than approx. 38)
- Weight greater than approx. 250 lbs
- Lifetime history of mania or psychosis
- At risk for suicide as determined by a clinical interview
- Gross impairment in functioning
- Claustrophobia
- Frank Axis I or Axis II psychopathology that would interfere with study participation, become exacerbated by study participation, or introduce scientific difficulties
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Cortisol first, Placebo second
Placebo first, Cortisol second
Single oral administration of 20 mg cortisol capsule to pharmacologically elevate cortisol levels during first functional magnetic resonance imaging (fMRI) session; Identically appearing placebo capsule during second fMRI session.
Placebo capsule during first fMRI session; Single oral administration of 20 mg cortisol capsule to pharmacologically elevate cortisol levels during second fMRI session.