Back to resultsPilot Study of Duloxetine in Psychological Resilience
Primary Purpose
Major Depressive Disorder
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Duloxetine
Sponsored by
About this trial
This is an interventional treatment trial for Major Depressive Disorder focused on measuring Depression, Pharmacotherapy, Duloxetine
Eligibility 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
Sites / Locations
- Duke University Medical Center
Arms of the Study
Arm 1
Arm Type
Active Comparator
Arm Label
1
Arm Description
Open label treatment with Duloxetine for 8 weeks with dosing from 30-60 mg.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00331799
Brief Title
Pilot Study of Duloxetine in Psychological Resilience
Official Title
A Pilot Study of Duloxetine in Psychological Resilience and Its Correlation With Blockade of Serotonin and Norepinephrine Transporter
Study Type
Interventional
2. Study Status
Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
July 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
Depression, Pharmacotherapy, Duloxetine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Open label treatment with Duloxetine for 8 weeks with dosing from 30-60 mg.
Intervention Type
Drug
Intervention Name(s)
Duloxetine
Other Intervention Name(s)
Cymbalta
Intervention Description
Open label treatment with Duloxetine for 8 wks. Dose 30-60 mg.
Primary Outcome Measure Information:
Title
Change in Connor Davidson Resilience Scale (CD-RISC) From Baseline to 8 Weeks
Description
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.
Time Frame
baseline and 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wei Zhang, MD, PhD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
11750180
Citation
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.
Results Reference
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PubMed Identifier
14754765
Citation
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.
Results Reference
background
PubMed Identifier
12964174
Citation
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.
Results Reference
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PubMed Identifier
16160626
Citation
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.
Results Reference
background
PubMed Identifier
12359676
Citation
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.
Results Reference
background
PubMed Identifier
12858150
Citation
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.
Results Reference
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Pilot Study of Duloxetine in Psychological Resilience
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