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

NCT00036309 | Completed Phase 3

• 2 other identifiers: 4445F1J-MC-HMBC
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Depressive Disorder

Keywords

Major Depressive Disorder; Diagnostic and Statistical Manual of Mental Disorders Fourth Edition-defined major depressive disorder without psychotic features

Interventions

Duloxetine Hydrochloride DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

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

Durham, North Carolina, United States

Location

Related Publications (1)

• 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.

  PMID: 17725843 DERIVED

MeSH Terms

Conditions

Depressive Disorder; Depressive Disorder, Major; Disease

Interventions

Duloxetine Hydrochloride

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 8, 2002
• First Posted: May 9, 2002
• Study Start: May 1, 2002
• Study Completion: July 1, 2003
• Last Updated: July 19, 2006

Record last verified: 2006-07

Locations

US (1)