Depression, Epinephrine, and Platelet Function

NCT ID: NCT00166114

Last Updated: 2015-07-23

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-02-28

Study Completion Date

2009-01-31

Brief Summary

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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

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Conditions

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Major Depressive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Escitalopram

Group Type ACTIVE_COMPARATOR

Escitalopram

Intervention Type DRUG

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

Desipramine

Group Type ACTIVE_COMPARATOR

Desipramine

Intervention Type 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

Interventions

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Escitalopram

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

Intervention Type 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

Intervention Type DRUG

Other Intervention Names

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Lexapro Norpramin

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

Emory University

OTHER

Sponsor Role lead

Responsible Party

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Dominique Musselman

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dominique L Musselman, MD,MS

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

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Emory University School of Medicine

Atlanta, Georgia, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 22966422 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18619999 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15953798 (View on PubMed)

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.

Reference Type RESULT
PMID: 18378867 (View on PubMed)

Other Identifiers

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1R01HL065523-01A2

Identifier Type: NIH

Identifier Source: secondary_id

View Link

0473-2002

Identifier Type: -

Identifier Source: org_study_id

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