Pilot Study of Duloxetine in Psychological Resilience

NCT00331799 | Completed Phase 2 Results DMC

• 1 other identifier: Pro00008715
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Major Depressive Disorder

Keywords

Depression; Pharmacotherapy; Duloxetine

Outcome Measures

Primary Outcomes (1)

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

  CD-RISC has been psychometrically validated, studied in the general population, as well as in clinical samples. Changes in CD-RISC score have been found to be sensitive to the effect of treatment, and impaired resilience has been demonstrated in subjects with depression relative to normal controls using this scale (Connor and Davidson, 2003). The total score ranges from 0-100, with higher scores indicating greater resilience.

  baseline and 8 weeks

Study Arms (1)

1

ACTIVE COMPARATOR

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

Drug: Duloxetine

Interventions

Duloxetine DRUG

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

Also known as: Cymbalta

1

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Related Publications (6)

• 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.

  PMID: 11750180 BACKGROUND

• 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.

  PMID: 14754765 BACKGROUND

• 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.

  PMID: 12964174 BACKGROUND

• 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.

  PMID: 16160626 BACKGROUND

• 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.

  PMID: 12359676 BACKGROUND

• 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.

  PMID: 12858150 BACKGROUND

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Interventions

Duloxetine Hydrochloride

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Wei Zhang MD
• Organization: Duke University Medical Center Dept of Psychiatry

wei.zhang@duke.edu

919 684 5645

Study Officials

• Wei Zhang, MD, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2006
• First Posted: May 31, 2006
• Study Start: April 1, 2007
• Primary Completion: May 1, 2008
• Study Completion: July 1, 2008
• Last Updated: August 2, 2013
• Results First Posted: August 2, 2013

Record last verified: 2013-06

Locations

US (1)