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Trial record 27 of 47 for:    DESIPRAMINE

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
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Dominique Musselman, Emory University

Tracking Information
First Submitted Date  ICMJE September 13, 2005
First Posted Date  ICMJE September 14, 2005
Results First Submitted Date  ICMJE December 9, 2013
Results First Posted Date  ICMJE July 23, 2015
Last Update Posted Date July 23, 2015
Study Start Date  ICMJE February 2002
Actual Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 15, 2015)
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
Original Primary Outcome Measures  ICMJE
 (submitted: September 13, 2005)
  • Study endpoints will include measures of (A)psychiatric function and
  • B. biologic parameters
  • A. Measurement of psychiatric function before and after treatment will include:
  • 1. Measurement of early life abuse: Early Trauma Inventory, Childhood Trauma Questionnaire
  • 2. Measurements of mood and anxiety symptoms: Hamilton Depression Rating Scale,
  • Zung Depression Rating Scale
  • 3. Measurements of anger and aggressive behaviors: Aggression Questionnaire,
  • Violence Scale,
  • B. Measures of neurobiologic function will include those of the HPA axis,
  • sympathomedullary axis,
  • immunoinflammatory mediators and
  • lipid metabolism,
  • oxidative stress,
  • platelet function, and
  • HRV.
  • 1. Measurements of HPA axis activity: adrenocorticotropin and cortisol.
  • 2. Measurements of epinephrine and norepinephrine.
  • 3. Measurements of immunoinflammatory mediators and lipid metabolism:IL-1, IL-6 and TNF, and autoantibodies (AAbs) to malondialdehyde-low density lipoprotein (MDA-LDL), and circulating levels of total cholesterol
  • 4. Measurement of oxidative stress
  • 5. Measurements of platelet function:
  • (a) platelet autocrine stimulation
  • i. release of platelet serotonin (whole blood concentrations) and platelet 5HT2 receptor binding,
  • ii. adenosine disphosphate (ADP) release, and
  • iii. thromboxane A2 production (as detected by serum and urine thromboxane B2
  • (b) increased platelet-surface epitopes, as detected by flow cytometric analysis of:
  • i. platelet expression of the GPIIb/IIIa receptor, as detected by the monoclonal antibody (mAb), anti-LIBS binding- measurement taken at pre-treatment, post week 1 treatment, and post-treatment.
  • ii. platelet expression of P-selectin,(as detected by mAb GA6 binding)- taken pretreatment, post-treatment week 1, and post treatment.
  • (c) platelet aggregation [as detected by diminished half-maximal aggregation concentration (AC50) of platelet agonists - taken at pre-treatment, week 1 of treatment, and post-treatment.
  • d. A Holter monitor will be utilized to determine Heart Rate variability- measurement taken pre-treatment and post-treatment.
Change History Complete list of historical versions of study NCT00166114 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Depression, Epinephrine, and Platelet Function
Official Title  ICMJE 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.
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Major Depressive Disorder
Intervention  ICMJE
  • Drug: Escitalopram
    10 mg of Escitalopram, and titrated up to 20 mg of Escitalopram after day 22 of intervention
    Other Name: Lexapro
  • 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
Study Arms  ICMJE
  • Active Comparator: Escitalopram
    Intervention: Drug: Escitalopram
  • Active Comparator: Desipramine
    Intervention: Drug: Desipramine
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 15, 2015)
40
Original Enrollment  ICMJE
 (submitted: September 13, 2005)
90
Actual Study Completion Date  ICMJE January 2009
Actual Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00166114
Other Study ID Numbers  ICMJE 0473-2002
1R01HL065523-01A2 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dominique Musselman, Emory University
Study Sponsor  ICMJE Emory University
Collaborators  ICMJE National Heart, Lung, and Blood Institute (NHLBI)
Investigators  ICMJE
Principal Investigator: Dominique L Musselman, MD,MS Emory University
PRS Account Emory University
Verification Date July 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP