Depression, Epinephrine, and Platelet Function
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. We expect to see that survivors of childhood adversity experience heightened negative emotions and increased physical responses to stress.
Description
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.
Study Design
Allocation: Randomized, Control: Uncontrolled, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Conditions
Major Depressive Disorder
Intervention
escitalopram or desipramine
Location
Emory University School of Medicine
Atlanta
Georgia
United States
30322
Status
Completed
Source
Emory University
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00166114
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Bipolar Disorder
A major affective disorder marked by severe mood swings (manic or major depressive episodes) and a tendency to remission and recurrence.
Trazodone
A serotonin uptake inhibitor that is used as an antidepressive agent. It has been shown to be effective in patients with major depressive disorders and other subsets of depressive disorders. It is generally more useful in depressive disorders associated with insomnia and anxiety. This drug does not aggravate psychotic symptoms in patients with schizophrenia or schizoaffective disorders. (From AMA Drug Evaluations Annual, 1994, p309)
Depressive Disorder, Major
Marked depression appearing in the involution period and characterized by hallucinations, delusions, paranoia, and agitation.
Desipramine
A tricyclic dibenzazepine compound that potentiates neurotransmission. Desipramine selectively blocks reuptake of norepinephrine from the neural synapse, and also appears to impair serotonin transport. This compound also possesses minor anticholinergic activity, through its affinity to muscarinic receptors.
Depressive Disorder
An affective disorder manifested by either a dysphoric mood or loss of interest or pleasure in usual activities. The mood disturbance is prominent and relatively persistent.
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