A Randomized Double Blind Study Evaluating Duloxetine in Outpatients With MDD and Pain

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ClinicalTrials.gov Identifier: NCT00191919

Recruitment Status : Completed

First Posted : September 19, 2005

Last Update Posted : January 26, 2007

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Sponsor:

Collaborator:

Boehringer Ingelheim

Information provided by:

Eli Lilly and Company

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Depressive Disorder, Major	Drug: Duloxetine Hydrochloride Drug: Placebo	Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Enrollment :	310 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double
Primary Purpose:	Treatment
Official Title:	A Ten-Week, Randomized, Double-Blind Study Evaluating the Efficacy of Duloxetine 60mg Once Daily Versus Placebo in Outpatients With Major Depressive Disorder and Pain
Study Start Date :	May 2005
Study Completion Date :	May 2006

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Depression

Drug Information available for: Duloxetine Duloxetine hydrochloride

U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :

Compare efficacy of Duloxetine versus placebo on somatic complaints of pain in patients meeting criteria for major depressive disorder.

Secondary Outcome Measures :

Measure Efficacy by the following: MADRS total score, time to sustained clinical response for painful physical symptoms, time to sustained clinical response for overall depression symptoms, SCL-90R scale, PGI-I, CGI-S, CGI-I and BPI-SF.
Measure safety by the following: adverse events, withdrawals due to AE, vital signs, weight and laboratory values.

Eligibility Criteria

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

Criteria

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

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

Contacts and Locations

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): NCT00191919

Locations

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Belgium
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Antwerpert, Belgium, 2018
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Assebroek, Belgium, 8310
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Asse, Belgium, 1730
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Diest, Belgium, 3290
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Genk, Belgium, 3600
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Leuven, Belgium, 3000
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Oostende, Belgium, 8400
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Yvoir, Belgium, 5530
Czech Republic
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Prague, Czech Republic
Finland
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Espoo, Finland, FI-02650
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Helsinki, Finland, FI-00530
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Tampere, Finland, FI-33200
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Turku, Finland, FI-20100
France
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Arcachon, France, 33120
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Cherbourg, France, 50100
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Elancourt, France, 78990
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Nantes-Orvault, France, 44700
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Paris, France, 75012
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Rennes, France, 35000
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Toulouse, France, 31200
Germany
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Berlin, Germany
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Bielefeld, Germany, 33647
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Bochum, Germany
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Chemnitz, Germany, 09111
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Erbach, Germany, 64711
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Freiburg, Germany, 79102
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Giessen, Germany, 35392
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Gottingen, Germany, 37075
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Hattingen, Germany, 45525
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Karlsruhe, Germany, 76199
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Kunzing, Germany, 94550
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Leipzig, Germany, 04105
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Mannheim, Germany, 68159
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Munchen, Germany, 80336
Slovakia
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Bratislava, Slovakia
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Kosice, Slovakia
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Michalovce, Slovakia
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Rimavaska Sobota, Slovakia

Sponsors and Collaborators

Eli Lilly and Company

Boehringer Ingelheim

Investigators

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Study Director:	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)	Eli Lilly and Company

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

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.

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ClinicalTrials.gov Identifier:	NCT00191919
Other Study ID Numbers:	8605 F1J-BI-HMDH
First Posted:	September 19, 2005 Key Record Dates
Last Update Posted:	January 26, 2007
Last Verified:	January 2007

Additional relevant MeSH terms:

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Depressive Disorder Depression Depressive Disorder, Major Mood Disorders Mental Disorders Behavioral Symptoms 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

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