Pilot Study of Duloxetine in Psychological Resilience - Full Text View

Purpose

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.

Condition	Intervention	Phase
Major Depressive Disorder	Drug: Duloxetine	Phase II Phase III

MedlinePlus related topics:

Depression

ChemIDplus related topics:

Serotonin Duloxetine Duloxetine hydrochloride Norepinephrine Norepinephrine bitartrate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study

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

Further study details as provided by Duke University:

Primary Outcome Measures:

Connor Davidson Resilience Scale [ Time Frame: 8Wks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Montgomery Asberg Depression Rating Scale [ Time Frame: 8 wks ] [ Designated as safety issue: Yes ]
Clinical Global Impression Improvement [ Time Frame: 8 wks ] [ Designated as safety issue: Yes ]
Hospital Anxiety and Depression Scale [ Time Frame: 8 wks ] [ Designated as safety issue: Yes ]
Serotonin and Norepinephrine reuptake inhibitors [ Time Frame: 8 wks ] [ Designated as safety issue: Yes ]
Percentage of CGI-I, MADRS [ Time Frame: 8 wks ] [ Designated as safety issue: Yes ]

Enrollment:	18
Study Start Date:	April 2007
Study Completion Date:	July 2008
Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Open label treatment with Duloxetine for 8 wks. Dose 30-60 mg.	Drug: Duloxetine Open label treatment with Duloxetine for 8 wks. Dose 30-60 mg.

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

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

ages 18-65
primary diagnosis of MDD based on 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 CGI 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00331799

Locations


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

Sponsors and Collaborators

Duke University

Investigators


Principal Investigator:	Wei Zhang, MD, PhD	Duke University

More Information

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.

Responsible Party:	DUMC ( Wei Zhang/ Director of Anxiety and Traumatic Stress Program )
Study ID Numbers:	1-Dougherty
First Received:	May 30, 2006
Last Updated:	August 13, 2008
ClinicalTrials.gov Identifier:	NCT00331799
Health Authority:	United States: Institutional Review Board

Keywords provided by Duke University:

Depression

Pharmacotherapy

Duloxetine

Study placed in the following topic categories:

Dopamine

Depression

Mental Disorders

Norepinephrine

Mood Disorders

Depressive Disorder, Major

Depressive Disorder

Serotonin

Duloxetine

Behavioral Symptoms

Additional relevant MeSH terms:

Dopamine Uptake Inhibitors

Neurotransmitter Uptake Inhibitors

Neurotransmitter Agents

Molecular Mechanisms of Pharmacological Action

Adrenergic Agents

Adrenergic Uptake Inhibitors

Physiological Effects of Drugs

Psychotropic Drugs

Serotonin Uptake Inhibitors

Pharmacologic Actions

Serotonin Agents

Therapeutic Uses

Dopamine Agents

Central Nervous System Agents

Antidepressive Agents

ClinicalTrials.gov processed this record on October 03, 2008

Sponsored by:	Duke University
Information provided by:	Duke University
ClinicalTrials.gov Identifier:	NCT00331799