NCT00191919

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

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
310

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started May 2005

Shorter than P25 for phase_3

Geographic Reach
6 countries

38 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 19, 2005

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2006

Completed
Last Updated

January 26, 2007

Status Verified

January 1, 2007

First QC Date

September 12, 2005

Last Update Submit

January 24, 2007

Conditions

Depressive Disorder, Major

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (2)

  • 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.

Interventions

Duloxetine HydrochlorideDRUG
PlaceboDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (38)

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, 2018, Belgium

Location

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Asse, 1730, Belgium

Location

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Assebroek, 8310, Belgium

Location

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Diest, 3290, Belgium

Location

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Genk, 3600, Belgium

Location

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Leuven, 3000, Belgium

Location

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Ostend, 8400, Belgium

Location

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Yvoir, 5530, Belgium

Location

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Prague, Czechia

Location

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Espoo, FI-02650, Finland

Location

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Helsinki, FI-00530, Finland

Location

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Tampere, FI-33200, Finland

Location

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Turku, FI-20100, Finland

Location

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Arcachon, 33120, France

Location

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Cherbourg, 50100, France

Location

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Élancourt, 78990, France

Location

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Nantes-Orvault, 44700, France

Location

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Paris, 75012, France

Location

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Rennes, 35000, France

Location

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Toulouse, 31200, France

Location

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Berlin, Germany

Location

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Bielefeld, 33647, Germany

Location

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Bochum, Germany

Location

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Chemnitz, 09111, Germany

Location

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Erbach im Odenwald, 64711, Germany

Location

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Freiburg im Breisgau, 79102, Germany

Location

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Giessen, 35392, Germany

Location

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Göttingen, 37075, Germany

Location

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Hattingen, 45525, Germany

Location

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Karlsruhe, 76199, Germany

Location

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Künzing, 94550, Germany

Location

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Leipzig, 04105, Germany

Location

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Mannheim, 68159, Germany

Location

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München, 80336, Germany

Location

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Bratislava, Slovakia

Location

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Košice, Slovakia

Location

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Michalovce, Slovakia

Location

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Rimavaska Sobota, Slovakia

Location

Related Publications (3)

  • 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.

    PMID: 22126422DERIVED

  • 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.

    PMID: 19333404DERIVED

  • 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.

    PMID: 18052564DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Duloxetine Hydrochloride

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

ThiophenesSulfur CompoundsOrganic ChemicalsHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • 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

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 19, 2005

Study Start

May 1, 2005

Study Completion

May 1, 2006

Last Updated

January 26, 2007

Record last verified: 2007-01

Locations

FI(4)SL(4)FR(7)BE(8)CZ(1)DE(14)