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

This study has been completed.

Sponsors and Collaborators: Eli Lilly and Company
Boehringer Ingelheim Pharmaceuticals
Information provided by: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00105989
  Purpose

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.


Condition Intervention Phase
Depressive Disorder, Major
Drug: Duloxetine
Drug: placebo
Phase III

MedlinePlus related topics:   Depression   

ChemIDplus related topics:   Duloxetine    Duloxetine hydrochloride   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:   Duloxetine Versus Placebo in the Prevention of Recurrence of Major Depressive Disorder

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Time to recurrence [ Time Frame: 52 to 54 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Recurrence rates [ Time Frame: 52 to 54 weeks ] [ Designated as safety issue: No ]
  • Time to greater than or equal to 50% worsening in the 17-item Hamilton Depression Rating Scale and the Clinical Global Impressions of Severity [ Time Frame: 52 to 54 weeks ] [ Designated as safety issue: No ]
  • Loss of response (HAMD greater than 9 and CGI-Severity greater than 2) at any time [ Time Frame: 52 to 54 weeks ] [ Designated as safety issue: No ]
  • HAMD-17 total score [ Time Frame: 4-10 weeks, 22-24 weeks and 52 to 54 weeks ] [ Designated as safety issue: No ]
  • CGI-Severity scale [ Time Frame: 4-10 weeks, 22-24 weeks and 52 to 54 weeks ] [ Designated as safety issue: No ]
  • Patient's Global Impressions of Improvement (PGI-I) [ Time Frame: 4-10 weeks, 22-24 weeks and 52 to 54 weeks ] [ Designated as safety issue: No ]
  • Hamilton Depression Rating Scale subscales, including the Core, Maier, Anxiety/Somatization, Retardation/Somatization, and Sleep subscales, and the depressed mood item. [ Time Frame: 4-10 weeks, 22-24 weeks and 52 to 54 weeks ] [ Designated as safety issue: No ]
  • Visual Analog Scales (VAS) for pain [ Time Frame: 4-10 weeks, 22-24 weeks and 52 to 54 weeks ] [ Designated as safety issue: No ]
  • Symptom Questionnaire-Somatic Subscale (SQ-SS) [ Time Frame: 4-10 weeks, 22-24 weeks and 52 to 54 weeks ] [ Designated as safety issue: No ]
  • Sheehan Disability Scale (SDS) [ Time Frame: 4-10 weeks, 22-24 weeks and 52 to 54 weeks ] [ Designated as safety issue: No ]
  • 36-item Short-Form Health Survey (SF-36) [ Time Frame: 4-10 weeks, 22-24 weeks and 52 to 54 weeks ] [ Designated as safety issue: No ]
  • Resource Utilization and Hospitalization Module [ Time Frame: 4-10 weeks, 22-24 weeks and 52 to 54 weeks ] [ Designated as safety issue: No ]
  • Treatment-emergent adverse events [ Time Frame: 4-10 weeks, 22-24 weeks and 52 to 54 weeks ] [ Designated as safety issue: Yes ]
  • Arizona Sexual Experience Scale (ASEX) [ Time Frame: 4-10 weeks, 22-24 weeks and 52 to 54 weeks ] [ Designated as safety issue: Yes ]
  • Vital signs [ Time Frame: 4-10 weeks, 22-24 weeks and 52 to 54 weeks ] [ Designated as safety issue: Yes ]
  • Laboratory measurements [ Time Frame: 4-10 weeks, 22-24 weeks and 52 to 54 weeks ] [ Designated as safety issue: Yes ]

Enrollment:   514
Study Start Date:   March 2005
Study Completion Date:   January 2008
Primary Completion Date:   January 2008 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
A: Experimental
duloxetine 60-120 mg QD, 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 QD, PO for 34 weeks followed by placebo QD, PO for up to 54 weeks
Drug: placebo

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00105989

Locations
United States, California
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.    
      Sherman Oaks, California, United States
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
United States, Maryland
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.    
      Baltimore, Maryland, United States
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.    
      Gaithersburg, Maryland, United States
United States, New York
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.    
      Brooklyn, New York, United States
France
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.    
      Angouleme, France
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.    
      Fains, France
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.    
      La Rochelle, France
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.    
      Nimes, France
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.    
      Strasbourg, France
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.    
      Lille, France
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.    
      Roubaix, France
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.    
      Douai, France
Germany
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.    
      Berlin, Germany
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.    
      Hildesheim, Germany
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.    
      Leipzig, Germany
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.    
      Munchen, Germany
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.    
      Wurzburg, Germany
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.    
      Ellwangen, Germany
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.    
      Hamburg, Germany
Italy
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.    
      Catania, Italy
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.    
      Ferrara, Italy
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.    
      Torino, Italy
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.    
      Parma, Italy
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.    
      Roma, Italy
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.    
      Firenze, Italy
Russian Federation
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.    
      Moscow, Russian Federation
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. Petersburg, Russian Federation
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.    
      Village Nikolskoe, Russian Federation
Sweden
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.    
      Lund, Sweden
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.    
      Halmstad, Sweden
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.    
      Stockholm, Sweden
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.    
      Sundsvall, Sweden
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.    
      Malmo, Sweden

Sponsors and Collaborators
Eli Lilly and Company
Boehringer Ingelheim Pharmaceuticals

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


Lilly Clinical Trial Registry  This link exits the ClinicalTrials.gov site
 

Responsible Party:   Eli Lilly ( Chief Medical Officer )
Study ID Numbers:   8606, F1J-MC-HMDI
First Received:   March 18, 2005
Last Updated:   September 26, 2008
ClinicalTrials.gov Identifier:   NCT00105989
Health Authority:   United States: Food and Drug Administration

Study placed in the following topic categories:
Dopamine
Depression
Mental Disorders
Mood Disorders
Depressive Disorder, Major
Depressive Disorder
Serotonin
Duloxetine
Recurrence
Behavioral Symptoms

Additional relevant MeSH terms:
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Disease
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Uptake Inhibitors
Pharmacologic Actions
Pathologic Processes
Serotonin Agents
Therapeutic Uses
Dopamine Agents
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on October 20, 2008




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