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

This study has been completed.
Sponsor:
Collaborator:
Boehringer Ingelheim
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00191919
First received: September 12, 2005
Last updated: January 24, 2007
Last verified: January 2007
  Purpose

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 Intervention Phase
Depressive Disorder, Major
Drug: Duloxetine Hydrochloride
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

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.

Estimated Enrollment: 310
Study Start Date: May 2005
Estimated Study Completion Date: May 2006
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00191919

Locations
Belgium
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Antwerpert, Belgium, 2018
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Asse, Belgium, 1730
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Assebroek, Belgium, 8310
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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
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

No publications provided by Eli Lilly and Company

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00191919     History of Changes
Other Study ID Numbers: 8605, F1J-BI-HMDH
Study First Received: September 12, 2005
Last Updated: January 24, 2007
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Duloxetine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Serotonin Agents
Physiological Effects of Drugs
Adrenergic Uptake Inhibitors
Adrenergic Agents
Dopamine Uptake Inhibitors
Dopamine Agents
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 15, 2014