Expired Study
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Atlanta, Georgia 30322


Purpose:

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. We expect to see that survivors of childhood adversity experience heightened negative emotions and increased physical responses to stress.


Study summary:

4 groups of men and 4 groups of women between the ages of 18 and 55 years old will have been recruited controls (n=15 for women; n=15 for men), those with early adversity (n=15 for women; n=15 for men) or major depression (n=15 for women; n=15 for men), and men with major depression who have suffered early adversity (n=15 for women; n=15 for men). To compare the emotional and physical function of these 4 groups of men they will be admitted to the General Clinical Research Center for 2.5 days for interviews about their emotions, a public speaking stress test, and administration of 2 stress hormone dexamethasone (by mouth) and corticotropin-releasing factor (in their veins) to assess their physical responses: changes in stress hormones, heart rate and blood pressure, and platelet function (clotting elements of the blood). Should they choose to do so, the 30 men and 30 women with major depression (15 without, and 15 with a history of early life adversity for both men and women) may enter this treatment study, a 8-week, double-blind, randomized, treatment with either the newer selective serotonin reuptake inhibitor (SSRI) antidepressant escitalopram or the older tricyclic antidepressant (TCA) desipramine. The SSRI escitalopram will affect the serotonin system in the brain and body while the TCA desipramine, which will affect the norepinephrine system. Clinical evaluations will be performed weekly, with blood samples will be drawn after 1 week and 4 weeks to evaluate the effects of the antidepressants on platelet function and antidepressant blood levels, respectively. The 8-week treatment will end with a 1-day GCRC stay in which the procedures of the first GCRC visit (except for the public speaking task) will be repeated to assess the effects of treatment on emotional and physical function. After the study, study subjects will be assisted with continuing their antidepressant treatment or tapering off their antidepressant if they wish, and in locating follow-up psychiatric treatment. Understanding of the long-standing consequences of childhood abuse, and determining whether treatment with a SSRI and/or TCA is effective, can then guide the further development of novel intervention strategies to counteract the emotional and physical effects of early adversity. Psychotherapy and/or antidepressant treatment is the standard care for individuals who have survived early childhood adversity, those who have major depression, or both conditions. Although SSRIs and TCAs are equally effective in the treatment of major depression, many individuals will report SSRI treatment as more tolerable over the long-term.


Criteria:

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. D - Depressed patients with a prior history of severe adverse events associated with SSRIs or TCAs will not be accepted into the study.


NCT ID:

NCT00166114


Primary Contact:

Principal Investigator
Dominique L Musselman, MD,MS
Emory University


Backup Contact:

N/A


Location Contact:

Atlanta, Georgia 30322
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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