MedPath

Depression, Epinephrine, and Platelet Function

Phase 4
Completed
Conditions
Major Depressive Disorder
Interventions
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
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
EscitalopramEscitalopram-
DesipramineDesipramine-
Primary Outcome Measures
NameTimeMethod
Response of Participants, Defined by Change in the 21-item Hamilton Depression Rating Scale (HDRS) From Baseline to Week8Baseline, 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
NameTimeMethod

Trial Locations

Locations (1)

Emory University School of Medicine

🇺🇸

Atlanta, Georgia, United States

Emory University School of Medicine
🇺🇸Atlanta, Georgia, United States
© Copyright 2025. All Rights Reserved by MedPath