Brief Summary

The purpose of this study is to assess the efficacy and safety of duloxetine compared with placebo in the prevention of depressive recurrences among patients with recurrent major depressive disorder.

Trial Health

On Track

Trial Health Score

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

Enrollment

514

participants targeted

Target at P75+ for phase_3

Timeline

Completed

Started Mar 2005

Typical duration for phase_3

Geographic Reach

6 countries

34 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

2.8 years study duration

Study Start

First participant enrolled

March 1, 2005

Completed

17 days until next milestone

First Submitted

Initial submission to the registry

March 18, 2005

Completed

3 days until next milestone

First Posted

Study publicly available on registry

March 21, 2005

Completed

2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed

1.5 years until next milestone

Results Posted

Study results publicly available

July 17, 2009

Completed

Last Updated

July 28, 2009

Status Verified

July 1, 2009

Enrollment Period

2.8 years

First QC Date

March 18, 2005

Results QC Date

January 23, 2009

Last Update Submit

July 21, 2009

Conditions

Depressive Disorder, Major

Outcome Measures

Primary Outcomes (1)

Percentage of Participants With Depressive Recurrence After Time (t) in Days
Recurrence: Clinical Global Impression-Severity (CGI-S) score \>=4 and met Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria for major depressive disorder (MDD); had 3 consecutive visits where re-emergence criteria met; had total of 10 visits where re-emergence criteria was satisfied; discontinued due to lack of efficacy.
Every Visit from Week 34 up to Week 86 (Maintenance Phase)

Secondary Outcomes (66)

Recurrence Count
Every Visit from Week 35 up to Week 86 (Maintenance Phase)
Percentage of Participants With Greater Than or Equal to 50% Worsening After Time (t) in Days
Every Visit from Week 34 up to Week 86 (Maintenance Phase)
Loss of Response at Any Time
Every Visit from Week 35 up to Week 86 (Maintenance Phase)
Change From Baseline to Endpoint in 17-Item Hamilton Depression Rating Scale (HAMD-17) Total Score - Acute and Continuation Phases
Week 0 and Week 10 (Acute) and Week 34 (Continuation)
Change From Baseline to Endpoint in 17-Item Hamilton Depression Rating Scale (HAMD-17) Total Score - Maintenance Phase
Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)
+61 more secondary outcomes

Study Arms (2)

A

EXPERIMENTAL

duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks

Drug: Duloxetine

B

PLACEBO COMPARATOR

duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks

Drug: placebo

Interventions

DuloxetineDRUG

Also known as: LY248686, Cymbalta

placeboDRUG

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Patient must be at least 18 years old.
Patient must be diagnosed with depression and have had previous episodes of depression.
Patient must sign informed consent.

You may not qualify if:

Female and pregnant or breastfeeding.
History of bipolar disorder, schizophrenia, or other psychotic disorders.
Suffer from a serious medical illness (other than depression) or abnormal laboratory result that would require a change in medication, intervention, or hospitalization.
Have been treated with a medication called monoamine oxidase inhibitor (MAOI) within 14 days of the start of the study, or potential need to use a MAOI within 5 days of finishing the study.
Have taken an antidepressant called fluoxetine within 30 days of the start of the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Eli Lilly and Companylead
Boehringer Ingelheimcollaborator

Study Sites (34)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Newport Beach, California, United States

Location

Sherman Oaks, California, United States

Location

Baltimore, Maryland, United States

Location

Gaithersburg, Maryland, United States

Location

Brooklyn, New York, United States

Location

Angoulême, France

Location

Douai, France

Location

Fains, France

Location

La Rochelle, France

Location

Lille, France

Location

Nîmes, France

Location

Roubaix, France

Location

Strasbourg, France

Location

Berlin, Germany

Location

Ellwangen, Germany

Location

Hamburg, Germany

Location

Hildesheim, Germany

Location

Leipzig, Germany

Location

München, Germany

Location

Würzburg, Germany

Location

Catania, Italy

Location

Ferrara, Italy

Location

Florence, Italy

Location

Parma, Italy

Location

Roma, Italy

Location

Torino, Italy

Location

Moscow, Russia

Location

Saint Petersburg, Russia

Location

Village Nikolskoe, Russia

Location

Halmstad, Sweden

Location

Lund, Sweden

Location

Malmo, Sweden

Location

Stockholm, Sweden

Location

Sundsvall, Sweden

Location

Related Publications (1)

Perahia DG, Maina G, Thase ME, Spann ME, Wang F, Walker DJ, Detke MJ. Duloxetine in the prevention of depressive recurrences: a randomized, double-blind, placebo-controlled trial. J Clin Psychiatry. 2009 May;70(5):706-16. doi: 10.4088/jcp.08m04756.
PMID: 19552867DERIVED

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

Results Point of Contact

Title: Chief Medical Officer
Organization: Eli Lilly and Company

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

Publication Agreements

PI is Sponsor Employee: No
Restriction Type: GT60
Restrictive Agreement: Yes

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: QUADRUPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY

Study Record Dates

First Submitted

March 18, 2005

First Posted

March 21, 2005

Study Start

March 1, 2005

Primary Completion

January 1, 2008

Study Completion

January 1, 2008

Last Updated

July 28, 2009

Results First Posted

July 17, 2009

Record last verified: 2009-07

Locations

RU(3)SE(5)IT(6)US(5)DE(7)FR(8)

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

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (66)

Study Arms (2)

A

B

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (34)

Related Publications (1)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Locations

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (66)

Study Arms (2)

A

B

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (34)

Related Publications (1)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Locations