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Pilot Study of Duloxetine in Psychological Resilience

Information source: Duke University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Major Depressive Disorder

Intervention: Duloxetine (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Duke University

Official(s) and/or principal investigator(s):
Wei Zhang, MD, PhD, Principal Investigator, Affiliation: Duke University

Summary

The purpose of this study is to explore benefits of duloxetine in enhancing psychological resilience and to understand the relevance of inhibiting of both serotonin (5HT) and norepinephrine (NE)to therapeutic responses.

Clinical Details

Official title: A Pilot Study of Duloxetine in Psychological Resilience and Its Correlation With Blockade of Serotonin and Norepinephrine Transporter

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Change in Connor Davidson Resilience Scale (CD-RISC) From Baseline to 8 Weeks

Detailed description: This is an investigator-initiated, single-site study consisting of 8 weeks of open-label, fixed-dose treatment with duloxetine (30mg-60mg/day) in patients with Major Depressive Disorder (MDD).

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- ages 18-65

- primary diagnosis of MDD based on Diagnostic Standard Manual(DSM-IV) criteria and

assessed by the MINI International Neuropsychiatric Interview

- Montgomery-Asberg Depression Rating Scale (MADRS)score of at least 20 on baseline

- Minimum Clinical Global Impressions of Severity (CGS) severity score of 4

- Ability to provide written consent form

- A negative serum pregnancy test for women of childbearing potential

Exclusion Criteria:

- Current DSM-IV diagnosis of bipolar disorder, schizophrenia or other psychotic

disorder, mental retardation or other pervasive developmental disorder or cognitive disorder due to a general medical condition

- History of substance abuse or dependence within the last 6 months

- Suicide risk or serious suicide attempt within the last year

- Clinically significant medical condition or laboratory abnormality

- Women of childbearing potential who are unwilling to practice an acceptable method of

contraception

- Subjects needing concurrent use of psychotropic medications

- History of sensitivity to duloxetine

- History of failure to respond to an adequate trial of duloxetine (at least 60mg/day

for 4 weeks)

- Subjects taking monoamine oxidase inhibitors (MAOIs)

- Subjects with uncontrolled narrow-angle glaucoma

Locations and Contacts

Duke University Medical Center, Durham, North Carolina 27710, United States
Additional Information

Related publications:

Bymaster FP, Dreshfield-Ahmad LJ, Threlkeld PG, Shaw JL, Thompson L, Nelson DL, Hemrick-Luecke SK, Wong DT. Comparative affinity of duloxetine and venlafaxine for serotonin and norepinephrine transporters in vitro and in vivo, human serotonin receptor subtypes, and other neuronal receptors. Neuropsychopharmacology. 2001 Dec;25(6):871-80.

Charney DS. Psychobiological mechanisms of resilience and vulnerability: implications for successful adaptation to extreme stress. Am J Psychiatry. 2004 Feb;161(2):195-216. Review.

Connor KM, Davidson JR. Development of a new resilience scale: the Connor-Davidson Resilience Scale (CD-RISC). Depress Anxiety. 2003;18(2):76-82.

Davidson J, Watkins L, Owens M, Krulewicz S, Connor K, Carpenter D, Krishnan R, Nemeroff C. Effects of paroxetine and venlafaxine XR on heart rate variability in depression. J Clin Psychopharmacol. 2005 Oct;25(5):480-4.

Gilmor ML, Owens MJ, Nemeroff CB. Inhibition of norepinephrine uptake in patients with major depression treated with paroxetine. Am J Psychiatry. 2002 Oct;159(10):1702-10.

Nemeroff CB, Schatzberg AF, Goldstein DJ, Detke MJ, Mallinckrodt C, Lu Y, Tran PV. Duloxetine for the treatment of major depressive disorder. Psychopharmacol Bull. 2002 Autumn;36(4):106-32.

Starting date: April 2007
Last updated: July 1, 2013

Page last updated: August 23, 2015

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