Depression, Epinephrine, and Platelet Function

NCT00166114 | Completed Phase 4 Results DMC

• 2 other identifiers: 0473-20021R01HL065523-01A2
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder

Keywords

platelet function; childhood abuse; depression; antidepressants; immune function; stress response

Outcome Measures

Primary Outcomes (1)

• Response of Participants, Defined by Change in the 21-item Hamilton Depression Rating Scale (HDRS) From Baseline to Week8

  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

  Baseline, Week 8

Study Arms (2)

Escitalopram

ACTIVE COMPARATOR

Drug: Escitalopram

Desipramine

ACTIVE COMPARATOR

Drug: Desipramine

Interventions

Escitalopram DRUG

10 mg of Escitalopram, and titrated up to 20 mg of Escitalopram after day 22 of intervention

Also known as: Lexapro

Escitalopram

Desipramine DRUG

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

Also known as: Norpramin

Desipramine

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Emory University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Emory University School of Medicine

Atlanta, Georgia, 30322, United States

Location

Related Publications (4)

• Royster EB, Trimble LM, Cotsonis G, Schmotzer B, Manatunga A, Rushing NN, Pagnoni G, Auyeung SF, Brown AR, Schoenbeck J, Murthy S, McDonald WM, Musselman DL. Changes in heart rate variability of depressed patients after electroconvulsive therapy. Cardiovasc Psychiatry Neurol. 2012;2012:794043. doi: 10.1155/2012/794043. Epub 2012 Aug 27.

  PMID: 22966422 BACKGROUND

• Shively CA, Musselman DL, Willard SL. Stress, depression, and coronary artery disease: modeling comorbidity in female primates. Neurosci Biobehav Rev. 2009 Feb;33(2):133-44. doi: 10.1016/j.neubiorev.2008.06.006. Epub 2008 Jun 24.

  PMID: 18619999 BACKGROUND

• Bruce EC, Musselman DL. Depression, alterations in platelet function, and ischemic heart disease. Psychosom Med. 2005 May-Jun;67 Suppl 1:S34-6. doi: 10.1097/01.psy.0000164227.63647.d9.

  PMID: 15953798 BACKGROUND

• Bruce EC, Guo Y, Lawson KC, Manatunga AK, Auyeung SF, McDonald WM, Rushing N, Brown AR, Gilles N, Emery M, Bonsall R, Porquez J, Stowe Z, Nemeroff CB, Musselman DL. Platelet thromboxane A2 secretion in patients with major depression responsive to electroconvulsive therapy. Psychosom Med. 2008 Apr;70(3):319-27. doi: 10.1097/PSY.0b013e3181663580. Epub 2008 Mar 31.

  PMID: 18378867 RESULT

MeSH Terms

Conditions

Depressive Disorder, Major; Depression; Fractures, Stress

Interventions

Escitalopram; Desipramine

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior; Fractures, Bone; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Dibenzazepines; Heterocyclic Compounds, 3-Ring

Results Point of Contact

• Title: Dominique Musselman, MD, MSCR
• Organization: University of Miami School of Medicine

dmusselman@med.miami.edu

404-723-8361

Study Officials

• Dominique L Musselman, MD,MS

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 14, 2005
• Study Start: February 1, 2002
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: July 23, 2015
• Results First Posted: July 23, 2015

Record last verified: 2015-07

Locations

US (1)