Depression, Epinephrine, and Platelet Function

Study Overview
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Brief Summary
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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.

Official Title
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Do Antidepressants Reverse the Effects of Early Life Stress on the Brain and Thrombovascular System and Improve Psychological, Neuroendocrine, and Platelet Function: A Study of Men and Women With Childhood Abuse.

Conditions
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Major Depressive Disorder

Intervention / Treatment
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* Drug: Escitalopram
* Drug: Desipramine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Escitalopram<br> | Drug: Escitalopram<br>* 10 mg of Escitalopram, and titrated up to 20 mg of Escitalopram after day 22 of intervention<br>* Other names: Lexapro;|
| Active Comparator: Desipramine<br> | Drug: Desipramine<br>* 25 mg of Desipramine for day 1-3, 50 mg of Desipramine for day 4-7, 75 mg of Desipramine for day 8-14, 100 mg of Desipramine for day 15-21. Titrated between 125 mg to 200 mg of Desipramine for day 22-56 of intervention<br>* Other names: Norpramin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response of Participants, Defined by Change in the 21-item Hamilton Depression Rating Scale (HDRS) From Baseline to Week8 | 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 | Baseline, Week 8 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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platelet function, childhood abuse, depression, antidepressants, immune function, stress response