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Pilot Study of Duloxetine in Psychological Resilience

NCT ID: NCT00331799

Last Updated: 2013-08-02

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Study Completion Date

2008-07-31

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Major Depressive Disorder

Keywords

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Depression Pharmacotherapy Duloxetine

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Open label treatment with Duloxetine for 8 weeks with dosing from 30-60 mg.

Group Type ACTIVE_COMPARATOR

Duloxetine

Intervention Type DRUG

Open label treatment with Duloxetine for 8 wks. Dose 30-60 mg.

Interventions

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Duloxetine

Open label treatment with Duloxetine for 8 wks. Dose 30-60 mg.

Intervention Type DRUG

Other Intervention Names

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Cymbalta

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Wei Zhang, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

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Duke University Medical Center

Durham, North Carolina, United States

Site Status

Countries

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United States

References

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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. doi: 10.1016/S0893-133X(01)00298-6.

Reference Type BACKGROUND
PMID: 11750180 (View on PubMed)

Charney DS. Psychobiological mechanisms of resilience and vulnerability: implications for successful adaptation to extreme stress. Am J Psychiatry. 2004 Feb;161(2):195-216. doi: 10.1176/appi.ajp.161.2.195.

Reference Type BACKGROUND
PMID: 14754765 (View on PubMed)

Connor KM, Davidson JR. Development of a new resilience scale: the Connor-Davidson Resilience Scale (CD-RISC). Depress Anxiety. 2003;18(2):76-82. doi: 10.1002/da.10113.

Reference Type BACKGROUND
PMID: 12964174 (View on PubMed)

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. doi: 10.1097/01.jcp.0000177547.28961.03.

Reference Type BACKGROUND
PMID: 16160626 (View on PubMed)

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. doi: 10.1176/appi.ajp.159.10.1702.

Reference Type BACKGROUND
PMID: 12359676 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12858150 (View on PubMed)

Other Identifiers

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Pro00008715

Identifier Type: -

Identifier Source: org_study_id