Back to results

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

Primary Purpose

Depressive Disorder, Major

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Duloxetine Hydrochloride

Placebo

About this trial

This is an interventional treatment trial for Depressive Disorder, Major

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Outcomes

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.

Full Information

NCT ID

NCT00191919

First Posted

September 12, 2005

Last Updated

January 24, 2007

Sponsor

Eli Lilly and Company

Collaborators

Boehringer Ingelheim

1. Study Identification

Unique Protocol Identification Number

NCT00191919

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

January 2007

Overall Recruitment Status

Completed

Study Start Date

May 2005 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

May 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Eli Lilly and Company

Collaborators

Boehringer Ingelheim

4. Oversight

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Depressive Disorder, Major

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

310 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Duloxetine Hydrochloride

Intervention Type

Drug

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

Measure safety by the following: adverse events, withdrawals due to AE, vital signs, weight and laboratory values.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

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)

Organizational Affiliation

Eli Lilly and Company

Official's Role

Study Director

Facility Information:

Facility Name

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.

City

Antwerpert

ZIP/Postal Code

2018

Country

Belgium

Facility Name

City

Assebroek

ZIP/Postal Code

8310

Country

Belgium

Facility Name

City

Asse

ZIP/Postal Code

1730

Country

Belgium

Facility Name

City

Diest

ZIP/Postal Code

3290

Country

Belgium

Facility Name

City

Genk

ZIP/Postal Code

3600

Country

Belgium

Facility Name

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

Facility Name

City

Oostende

ZIP/Postal Code

8400

Country

Belgium

Facility Name

City

Yvoir

ZIP/Postal Code

5530

Country

Belgium

Facility Name

City

Prague

Country

Czech Republic

Facility Name

City

Espoo

ZIP/Postal Code

FI-02650

Country

Finland

Facility Name

City

Helsinki

ZIP/Postal Code

FI-00530

Country

Finland

Facility Name

City

Tampere

ZIP/Postal Code

FI-33200

Country

Finland

Facility Name

City

Turku

ZIP/Postal Code

FI-20100

Country

Finland

Facility Name

City

Arcachon

ZIP/Postal Code

33120

Country

France

Facility Name

City

Cherbourg

ZIP/Postal Code

50100

Country

France

Facility Name

City

Elancourt

ZIP/Postal Code

78990

Country

France

Facility Name

City

Nantes-Orvault

ZIP/Postal Code

44700

Country

France

Facility Name

City

Paris

ZIP/Postal Code

75012

Country

France

Facility Name

City

Rennes

ZIP/Postal Code

35000

Country

France

Facility Name

City

Toulouse

ZIP/Postal Code

31200

Country

France

Facility Name

City

Berlin

Country

Germany

Facility Name

City

Bielefeld

ZIP/Postal Code

33647

Country

Germany

Facility Name

City

Bochum

Country

Germany

Facility Name

City

Chemnitz

ZIP/Postal Code

09111

Country

Germany

Facility Name

City

Erbach

ZIP/Postal Code

64711

Country

Germany

Facility Name

City

Freiburg

ZIP/Postal Code

79102

Country

Germany

Facility Name

City

Giessen

ZIP/Postal Code

35392

Country

Germany

Facility Name

City

Gottingen

ZIP/Postal Code

37075

Country

Germany

Facility Name

City

Hattingen

ZIP/Postal Code

45525

Country

Germany

Facility Name

City

Karlsruhe

ZIP/Postal Code

76199

Country

Germany

Facility Name

City

Kunzing

ZIP/Postal Code

94550

Country

Germany

Facility Name

City

Leipzig

ZIP/Postal Code

04105

Country

Germany

Facility Name

City

Mannheim

ZIP/Postal Code

68159

Country

Germany

Facility Name

City

Munchen

ZIP/Postal Code

80336

Country

Germany

Facility Name

City

Bratislava

Country

Slovakia

Facility Name

City

Kosice

Country

Slovakia

Facility Name

City

Michalovce

Country

Slovakia

Facility Name

City

Rimavaska Sobota

Country

Slovakia

12. IPD Sharing Statement

Citations:

PubMed Identifier

22126422

Citation

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.

Results Reference

derived

PubMed Identifier

19333404

Citation

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.

Results Reference

derived

PubMed Identifier

18052564

Citation

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.

Results Reference

derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs