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Depression, Epinephrine, and Platelet Function

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ClinicalTrials.gov Identifier: NCT00166114
Recruitment Status : Completed
First Posted : September 14, 2005
Results First Posted : July 23, 2015
Last Update Posted : July 23, 2015
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Dominique Musselman, 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.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Drug: Escitalopram Drug: Desipramine Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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.
Study Start Date : February 2002
Primary Completion Date : January 2009
Study Completion Date : January 2009

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Response of Participants, Defined by Change in the 21-item Hamilton Depression Rating Scale (HDRS) From Baseline to Week8 [ Time Frame: Baseline, 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Dominique Musselman, Associate Professor, Emory University
ClinicalTrials.gov Identifier: NCT00166114     History of Changes
Other Study ID Numbers: 0473-2002
1R01HL065523-01A2 ( U.S. NIH Grant/Contract )
First Posted: September 14, 2005    Key Record Dates
Results First Posted: July 23, 2015
Last Update Posted: July 23, 2015
Last Verified: July 2015

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

Additional relevant MeSH terms:
Depressive Disorder
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antiparkinson Agents
Anti-Dyskinesia Agents
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Antidepressive Agents, Tricyclic
Enzyme Inhibitors
Adrenergic Uptake Inhibitors