Depression, Epinephrine, and Platelet Function
- Registration Number
- NCT00166114
- Lead Sponsor
- Emory University
- Brief Summary
Men and women who have suffered sexual and/or physical abuse before the age of 12 are at increased risk for anxiety and mood disorders, other serious psychiatric disorders, and likely medical illnesses. What is not known is whether adult survivors of childhood adversity experience heightened negative emotions and increased physical responses due to altered norepinephrine or serotonin systems in their brains and bodies. The investigators expect to see that survivors of childhood adversity experience heightened negative emotions and increased physical responses to stress.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
- Individuals who are suicidal, psychotic, or with bipolar depression
- alcohol or substance abuse or
- regularly use medications which alter mood or blood vessel function (zolpidem or zalpelon, aspirin, nonsteroidal antiinflammatory drugs, sympatholytics, theophylline, central acting agonists, beta-blockers, coumadin, nitrates, triazolobenzodiazapines, or use steroids (testosterone-patch or pill form), use tryptophan or monoamine oxidase inhibitors (MAOIs),
- have narrow-angle glaucoma, liver disease,
- severe allergies (especially to antidepressants similar to escitalopram or desipramine)
- seizures, or a serious medical disorder (e.g. hypothyroidism) that is unstable or is untreated.
- Depressed patients with a prior history of severe adverse events associated with SSRIs or TCAs will not be accepted into the study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Escitalopram Escitalopram - Desipramine Desipramine -
- Primary Outcome Measures
Name Time Method Response of Participants, Defined by Change in the 21-item Hamilton Depression Rating Scale (HDRS) From Baseline to Week8 Baseline, Week 8 Number of subjects that showed no response, partial response, and response based on scores from baseline and week 8.
The 21-item HDRS measures depression severity. The scoring is sum the total of all 21 items to arrive at the total score, with a range of 0 to 60, where higher scores indicated greater severity. Nine items are scored on a 5-point scale, ranging from 0 = not present to 4 = severe. Eleven items are scored from 0 - 2 (0 = absent and 2 = severe). The last item is scored on a 4-point scale of 0-3 (0 = absent and 3 = severe). The HDRS at week 8 was compared to the baseline HDRS and each participant's response was calculated using the below table:
No Response = \< 25% change in Depression Rating Scale Score Partial Responder = \< 50% to \>25% change in Depression Rating Scale Score Responder = 50% or greater change in Depression Rating Scale Score
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Emory University School of Medicine
🇺🇸Atlanta, Georgia, United States
Emory University School of Medicine🇺🇸Atlanta, Georgia, United States