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Pilot Study of Duloxetine in Psychological Resilience

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00331799
Recruitment Status : Completed
First Posted : May 31, 2006
Results First Posted : August 2, 2013
Last Update Posted : August 2, 2013
Sponsor:
Information provided by (Responsible Party):
Duke University

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.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Drug: Duloxetine Phase 2

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study of Duloxetine in Psychological Resilience and Its Correlation With Blockade of Serotonin and Norepinephrine Transporter
Study Start Date : April 2007
Actual Primary Completion Date : May 2008
Actual Study Completion Date : July 2008

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 1
Open label treatment with Duloxetine for 8 weeks with dosing from 30-60 mg.
Drug: Duloxetine
Open label treatment with Duloxetine for 8 wks. Dose 30-60 mg.
Other Name: Cymbalta




Primary Outcome Measures :
  1. Change in Connor Davidson Resilience Scale (CD-RISC) From Baseline to 8 Weeks [ Time Frame: baseline and 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00331799


Locations
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United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Investigators
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Principal Investigator: Wei Zhang, MD, PhD Duke University
Publications:
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00331799    
Other Study ID Numbers: Pro00008715
First Posted: May 31, 2006    Key Record Dates
Results First Posted: August 2, 2013
Last Update Posted: August 2, 2013
Last Verified: June 2013
Keywords provided by Duke University:
Depression
Pharmacotherapy
Duloxetine
Additional relevant MeSH terms:
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Depressive Disorder
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Duloxetine Hydrochloride
Serotonin and Noradrenaline Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antidepressive Agents
Psychotropic Drugs
Dopamine Agents