Duloxetine Versus Placebo in the Prevention of Relapse of... | NCT00036309

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

NCT00036309

Sponsor

Eli Lilly and Company

Status

Completed

Last Update Posted

Jul 19, 2006Estimated

Enrollment

Not provided

Phase

Phase 3

Conditions

Depressive Disorder

Interventions

Duloxetine Hydrochloride

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
F1J-MC-HMBC

Status Module

Record Verification Date

Jul 2006

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

May 2002

Primary Completion Date

Not provided

Completion Date

Jul 2003

First Submitted Date

May 8, 2002

First Submission Date that Met QC Criteria

May 8, 2002

First Posted Date

May 9, 2002Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 18, 2006

Last Update Posted Date

Jul 19, 2006Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Name	Type	Description	Arm Group Labels	Other Names
Duloxetine Hydrochloride	Drug

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
For information on a site near you, call our call center at 1-877-CTLILLY (1-877-285-4559)		Durham	North Carolina		United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
17725843	Derived	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.

ID	Term
D003866	Depressive Disorder
D003865	Depressive Disorder, Major
D004194	Disease

ID	Term
D019964	Mood Disorders
D001523	Mental Disorders
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D013876	Thiophenes
D013457	Sulfur Compounds
D009930	Organic Chemicals
D006573	Heterocyclic Compounds, 1-Ring