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Duloxetine Versus Placebo in the Prevention of Relapse of Major Depressive Disorder

Primary Purpose

Depressive Disorder

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Duloxetine Hydrochloride
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depressive Disorder focused on measuring Major Depressive Disorder, Diagnostic and Statistical Manual of Mental Disorders Fourth Edition-defined major depressive disorder without psychotic features

Eligibility Criteria

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

Inclusion Criteria: Signed the informed consent Meet criteria for major depressive disorder without psychotic features. Have a level of understanding sufficient to provide informed consent and to communicate with the investigator and site personnel. Have had at least one other major depressive episode prior to the one being experienced at study entry. You are reliable and agree to keep all appointments for clinic visits, tests and procedures required by the protocol. Exclusion Criteria: You have had treatment with a drug within the last 30 days that has not received regulatory approval at the time of study entry. Any women who are pregnant or breast feeding. If you have any serious medical illnesses other than major depressive disorder. If you have previously participated in a clinical trial for duloxetine. Any previous or current diagnosis of bipolar, schizophrenia, or other psychotic disorders.

Sites / Locations

  • For information on a site near you, call our call center at 1-877-CTLILLY (1-877-285-4559)

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
May 8, 2002
Last Updated
July 18, 2006
Sponsor
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT00036309
Brief Title
Duloxetine Versus Placebo in the Prevention of Relapse of Major Depressive Disorder
Official Title
Duloxetine Versus Placebo in the Prevention of Relapse of Major Depressive Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
July 2006
Overall Recruitment Status
Completed
Study Start Date
May 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2003 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Eli Lilly and Company

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to determine if duloxetine is effective when compared to placebo in preventing recurrence of major depressive disorder in patients who have responded to open-label duloxetine treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Disorder
Keywords
Major Depressive Disorder, Diagnostic and Statistical Manual of Mental Disorders Fourth Edition-defined major depressive disorder without psychotic features

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Duloxetine Hydrochloride

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Signed the informed consent Meet criteria for major depressive disorder without psychotic features. Have a level of understanding sufficient to provide informed consent and to communicate with the investigator and site personnel. Have had at least one other major depressive episode prior to the one being experienced at study entry. You are reliable and agree to keep all appointments for clinic visits, tests and procedures required by the protocol. Exclusion Criteria: You have had treatment with a drug within the last 30 days that has not received regulatory approval at the time of study entry. Any women who are pregnant or breast feeding. If you have any serious medical illnesses other than major depressive disorder. If you have previously participated in a clinical trial for duloxetine. Any previous or current diagnosis of bipolar, schizophrenia, or other psychotic disorders.
Facility Information:
Facility Name
For information on a site near you, call our call center at 1-877-CTLILLY (1-877-285-4559)
City
Durham
State/Province
North Carolina
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
17725843
Citation
Hudson JI, Perahia DG, Gilaberte I, Wang F, Watkin JG, Detke MJ. Duloxetine in the treatment of major depressive disorder: an open-label study. BMC Psychiatry. 2007 Aug 28;7:43. doi: 10.1186/1471-244X-7-43.
Results Reference
derived

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Duloxetine Versus Placebo in the Prevention of Relapse of Major Depressive Disorder

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