A Randomized Double Blind Study Evaluating Duloxetine in Outpatients With MDD and Pain
NCT ID: NCT00191919
Last Updated: 2007-01-26
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE3
Total Enrollment
310 participants
Study Classification
INTERVENTIONAL
Study Start Date
2005-05-31
Study Completion Date
2006-05-31
Brief Summary
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To determine the efficacy of Duloxetine vs. placebo on pain as determined by change in the Brief Pain Inventory (BPI) from baseline over 8 weeks of treatment
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Detailed Description
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Conditions
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Depressive Disorder, Major
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
DOUBLE
Interventions
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Duloxetine Hydrochloride
Intervention Type
DRUG
Placebo
Intervention Type
DRUG
Eligibility Criteria
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Inclusion Criteria
* Major Depressive Disorder according to DSM-IV criteria with at least one previous depressive episode in the patient's medical history
* Painful physical symptoms as measured by the Brief Pain Inventory-Short Form
* Painful physical symptoms as measured by the Brief Pain Inventory-Short Form
Exclusion Criteria
* Any anxiety disorder as a primary diagnosis within the past 6 months (including panic disorder, OCD, PTSD, generalized anxiety disorder and social phobia)
* Any diagnosis of bipolar disorder, schizophrenia, or other psychotic disorders
* Any diagnosis of bipolar disorder, schizophrenia, or other psychotic disorders
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Sponsor Role
collaborator
Eli Lilly and Company
INDUSTRY
Sponsor Role
lead
Principal Investigators
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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Antwerpert, , Belgium
Site Status
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Asse, , Belgium
Site Status
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Assebroek, , Belgium
Site Status
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Diest, , Belgium
Site Status
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Genk, , Belgium
Site Status
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Leuven, , Belgium
Site Status
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Ostend, , Belgium
Site Status
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Yvoir, , Belgium
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Prague, , Czechia
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Espoo, , Finland
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Helsinki, , Finland
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Tampere, , Finland
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Turku, , Finland
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Arcachon, , France
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Cherbourg, , France
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Élancourt, , France
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Nantes-Orvault, , France
Site Status
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Paris, , France
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Rennes, , France
Site Status
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Toulouse, , France
Site Status
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Berlin, , Germany
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Bielefeld, , Germany
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Bochum, , Germany
Site Status
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Chemnitz, , Germany
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Erbach im Odenwald, , Germany
Site Status
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Freiburg im Breisgau, , Germany
Site Status
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Giessen, , Germany
Site Status
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Göttingen, , Germany
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Hattingen, , Germany
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Karlsruhe, , Germany
Site Status
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Künzing, , Germany
Site Status
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Leipzig, , Germany
Site Status
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Mannheim, , Germany
Site Status
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München, , Germany
Site Status
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Bratislava, , Slovakia
Site Status
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Košice, , Slovakia
Site Status
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Michalovce, , Slovakia
Site Status
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Rimavaska Sobota, , Slovakia
Site Status
Countries
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Belgium
Czechia
Finland
France
Germany
Slovakia
References
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Demyttenaere K, Desaiah D, Petit C, Croenlein J, Brecht S. Time course of improvement of different symptom clusters in patients with major depression and pain treated with duloxetine or placebo. Curr Med Res Opin. 2012 Jan;28(1):41-8. doi: 10.1185/03007995.2011.645561. Epub 2011 Dec 22.
Reference Type
DERIVED
Demyttenaere K, Desaiah D, Petit C, Croenlein J, Brecht S. Patient-assessed versus physician-assessed disease severity and outcome in patients with nonspecific pain associated with major depressive disorder. Prim Care Companion J Clin Psychiatry. 2009;11(1):8-15. doi: 10.4088/pcc.08m00670.
Reference Type
DERIVED
Brecht S, Courtecuisse C, Debieuvre C, Croenlein J, Desaiah D, Raskin J, Petit C, Demyttenaere K. Efficacy and safety of duloxetine 60 mg once daily in the treatment of pain in patients with major depressive disorder and at least moderate pain of unknown etiology: a randomized controlled trial. J Clin Psychiatry. 2007 Nov;68(11):1707-16. doi: 10.4088/jcp.v68n1110.
Reference Type
DERIVED
Other Identifiers
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F1J-BI-HMDH
Identifier Type: -
Identifier Source: secondary_id
8605
Identifier Type: -
Identifier Source: org_study_id
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