Depression, Epinephrine, and Platelet Function

This study has been completed.
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Dominique Musselman, Emory University Identifier:
First received: September 13, 2005
Last updated: July 15, 2015
Last verified: July 2015
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.

Condition Intervention Phase
Major Depressive Disorder
Drug: Escitalopram
Drug: Desipramine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:

Further study details as provided by Emory University:

Primary Outcome Measures:
  • Response of Participants, Defined by Change in the 21-item Hamilton Depression Rating Scale (HDRS) From Baseline to Week8 [ Time Frame: Baseline, Week 8 ] [ Designated as safety issue: No ]

    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

Enrollment: 40
Study Start Date: February 2002
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Escitalopram Drug: Escitalopram
10 mg of Escitalopram, and titrated up to 20 mg of Escitalopram after day 22 of intervention
Other Name: Lexapro
Active Comparator: Desipramine Drug: Desipramine
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
Other Name: Norpramin


Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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.
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Please refer to this study by its identifier: NCT00166114

United States, Georgia
Emory University School of Medicine
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Dominique L Musselman, MD,MS Emory University
  More Information

Responsible Party: Dominique Musselman, Associate Professor, Emory University Identifier: NCT00166114     History of Changes
Other Study ID Numbers: 0473-2002, 1 RO1 HL65523-01A2
Study First Received: September 13, 2005
Results First Received: December 9, 2013
Last Updated: July 15, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Emory University:
platelet function
childhood abuse
immune function
stress response

Additional relevant MeSH terms:
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mental Disorders
Mood Disorders
Adrenergic Agents
Adrenergic Uptake Inhibitors
Anti-Dyskinesia Agents
Antidepressive Agents
Antidepressive Agents, Second-Generation
Antidepressive Agents, Tricyclic
Antiparkinson Agents
Autonomic Agents
Central Nervous System Agents
Cholinergic Agents
Cholinergic Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Muscarinic Antagonists
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs processed this record on November 24, 2015