Brief Summary

The purpose of this study is to determine the optimal treatment strategy for MDD patients with melancholic features who do not respond to a standard daily dose. This study will allow investigators to mimic standard clinical practice. During the first 2 weeks of treatment, clinical evaluation of individual patient tolerability and efficacy will enable the dose of duloxetine to be adjusted. Patients allocated to the Flex group may have their daily dose of duloxetine adjusted in the attempt to elicit a clinical response.

Trial Health

On Track

Trial Health Score

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

Enrollment

200

participants targeted

Target at P25-P50 for phase_3

Timeline

Completed

Started May 2004

Shorter than P25 for phase_3

Geographic Reach

2 countries

23 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

1.3 years study duration

Study Start

First participant enrolled

May 1, 2004

Completed

1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2005

Completed

11 days until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed

7 days until next milestone

First Posted

Study publicly available on registry

September 19, 2005

Completed

Last Updated

July 25, 2006

Status Verified

July 1, 2006

First QC Date

September 12, 2005

Last Update Submit

July 21, 2006

Conditions

Depressive Disorder, Major

Outcome Measures

Primary Outcomes (1)

To generate data to compare the proportion of outpatients with major depressive disorder with melancholic features who responded to duloxetine at a given daily dose after initially not responding to duloxetine 60mg once daily for 4 weeks.

Secondary Outcomes (1)

To compare outpatients with major depressive disorder with melancholic features who achieved remission after treatment with duloxetine;Collect data on the safety of duloxetine.

Interventions

duloxetineDRUG

Eligibility Criteria

Age18 Years - 65 Years

Sexall

Healthy VolunteersNo

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

You may qualify if:

Have a diagnosis of major depression with melancholic features, as defined by Diagnostic and Statistical Manual of Mental Disorders Fourth Edition \[DSM-IV\] criteria.
Experienced their first episode of major depression prior to age 50.
Have a HAMD17 total score of less than or equal to 20 at Visits 1 and 2.
Test negative for a urine pregnancy test at Visit 1 (females).
Agree to use medically acceptable and reliable means of birth control during the study, as determined by the investigator (females of child-bearing potential, not surgically sterilized and between menarche, and one year post-menopausal).

You may not qualify if:

Have any current and primary Axis I mood disorder other than MDD, including, but not limited to, dysthymia, seasonal affective disorder or psychotic depression.
Have a current episode of major depression that has failed to respond to two or more courses of antidepressant therapy or, in the judgment of the investigator, meets criteria for treatment-resistant depression
Are at serious suicidal risk as determined by the investigator.
Have a serious medical illness or clinically significant laboratory abnormalities that, in the judgment of the investigator, are likely to require medication/ intervention/ hospitalization during the course of the study.
Had treatment with a monoamine oxidase inhibitor (MAOI) within 14 days prior to Visit 2 or potential need to use a MAOI during the study or within 14 days of discontinuation of study drug.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Eli Lilly and Companylead

Study Sites (23)

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.

Paddington, New South Wales, Australia

Location

Everton Park, Queensland, Australia

Location

Hoppers Crossing, Queensland, Australia

Location

Nambour, Queensland, Australia

Location

New Farm, Queensland, Australia

Location

South Port BC, Queensland, Australia

Location

Elizabeth Vale, South Australia, Australia

Location

Richmond, Victoria, Australia

Location

Calgary, Alberta, Canada

Location

Edmonton, Alberta, Canada

Location

Vancouver, British Columbia, Canada

Location

Winnipeg, Manitoba, Canada

Location

Saint John, New Brunswick, Canada

Location

Halifax, Nova Scotia, Canada

Location

Sydney, Nova Scotia, Canada

Location

Greater Sudbury, Ontario, Canada

Location

Kingston, Ontario, Canada

Location

London, Ontario, Canada

Location

Mississauga, Ontario, Canada

Location

Toronto, Ontario, Canada

Location

Beauport, Quebec, Canada

Location

Montreal, Quebec, Canada

Location

Québec, Quebec, Canada

Location

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

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

Study Design

Study Type: interventional
Phase: phase 3
Allocation: NON RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 19, 2005

Study Start

May 1, 2004

Study Completion

September 1, 2005

Last Updated

July 25, 2006

Record last verified: 2006-07

Locations

AU(8)CA(15)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (23)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Locations