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Duloxetine in the Treatment of Melancholic Depression
This study has been completed.
First Received: September 12, 2005   Last Updated: July 21, 2006   History of Changes
Sponsored by: Eli Lilly and Company
Information provided by: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00191685
  Purpose

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.


Condition Intervention Phase
Depressive Disorder, Major
Drug: duloxetine
Phase III

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: Duloxetine in the Treatment of Melancholic Depression: An 8-Week Open-Label Dose Study

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

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

Estimated Enrollment: 200
Study Start Date: May 2004
Estimated Study Completion Date: September 2005
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00191685

Locations
Australia, New South Wales
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
Australia, Queensland
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.
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
Australia, South 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.
Elizabeth Vale, South Australia, Australia
Australia, Victoria
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.
Richmond, Victoria, Australia
Canada, Alberta
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.
Calgary, Alberta, Canada
Canada, British Columbia
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.
Vancouver, British Columbia, Canada
Canada, Manitoba
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.
Winnipeg, Manitoba, Canada
Canada, New Brunswick
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.
St. John, New Brunswick, Canada
Canada, Nova Scotia
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.
Halifax, Nova Scotia, Canada
Canada, Ontario
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.
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.
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.
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
Canada, Quebec
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.
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
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: 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
  More Information

No publications provided

Study ID Numbers: 8163, F1J-AY-HMCZ
Study First Received: September 12, 2005
Last Updated: July 21, 2006
ClinicalTrials.gov Identifier: NCT00191685     History of Changes
Health Authority: Canada: Health Canada

Study placed in the following topic categories:
Dopamine Uptake Inhibitors
Neurotransmitter Agents
Depression
Adrenergic Agents
Psychotropic Drugs
Depressive Disorder, Major
Depressive Disorder
Serotonin Uptake Inhibitors
Duloxetine
Serotonin
Behavioral Symptoms
Dopamine
Mental Disorders
Mood Disorders
Dopamine Agents
Antidepressive Agents

Additional relevant MeSH terms:
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Depression
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Uptake Inhibitors
Physiological Effects of Drugs
Psychotropic Drugs
Depressive Disorder, Major
Depressive Disorder
Serotonin Uptake Inhibitors
Duloxetine
Pharmacologic Actions
Behavioral Symptoms
Serotonin Agents
Mental Disorders
Therapeutic Uses
Mood Disorders
Dopamine Agents
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on September 02, 2009