Duloxetine in the Treatment of Melancholic Depression

July 21, 2006 updated by: Eli Lilly and Company

Duloxetine in the Treatment of Melancholic Depression: An 8-Week Open-Label Dose Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

200

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Paddington, New South Wales, Australia
        • 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.
    • Queensland
      • Everton Park, Queensland, Australia
        • 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.
      • Hoppers Crossing, Queensland, Australia
        • 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.
      • Nambour, Queensland, Australia
        • 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.
      • New Farm, Queensland, Australia
        • 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.
      • South Port BC, Queensland, Australia
        • 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.
    • South Australia
      • Elizabeth Vale, South Australia, Australia
        • 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.
    • Victoria
      • Richmond, Victoria, Australia
        • 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.
  • Canada
    • Alberta
      • Calgary, Alberta, Canada
        • 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.
      • Edmonton, Alberta, Canada
        • 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.
    • British Columbia
      • Vancouver, British Columbia, Canada
        • 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.
    • Manitoba
      • Winnipeg, Manitoba, Canada
        • 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.
    • New Brunswick
      • St. John, New Brunswick, Canada
        • 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.
    • Nova Scotia
      • Halifax, Nova Scotia, Canada
        • 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.
      • Sydney, Nova Scotia, Canada
        • 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.
    • Ontario
      • Kingston, Ontario, Canada
        • 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.
      • London, Ontario, Canada
        • 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.
      • Mississauga, Ontario, Canada
        • 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.
      • Sudbury, Ontario, Canada
        • 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.
      • Toronto, Ontario, Canada
        • 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.
    • Quebec
      • Beauport, Quebec, Canada
        • 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.
      • Montreal, Quebec, Canada
        • 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.
      • Quebec City, Quebec, Canada
        • 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.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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 Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2004

Study Completion

September 1, 2005

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 19, 2005

Study Record Updates

Last Update Posted (Estimate)

July 25, 2006

Last Update Submitted That Met QC Criteria

July 21, 2006

Last Verified

July 1, 2006

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8163
  • F1J-AY-HMCZ

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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