ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Duloxetine Compared to Escitalopram and Placebo in the Treatment of Patients With Depression

This study has been completed.

Sponsored by: Eli Lilly and Company
Information provided by: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00073411
  Purpose

The purposes of this study are to determine:

  • The safety of duloxetine and any side effects that might be associated with it.
  • How duloxetine compares to escitalopram and placebo (an inactive ingredient)

Condition Intervention Phase
Depression
Drug: duloxetine
Drug: escitalopram
Drug: placebo
Phase III

MedlinePlus related topics:   Depression   

ChemIDplus related topics:   Escitalopram    Benzetimide    Citalopram    Citalopram hydrobromide    Dexetimide    Escitalopram oxalate    Duloxetine    Duloxetine hydrochloride   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:   Duloxetine Versus Escitalopram and Placebo in the Treatment of Patients With Major Depression

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • To compare the onset of antidepressant efficacy for duloxetine 60 mg once-daily compared with escitalopram 10 mg once-daily.

Secondary Outcome Measures:
  • To compare the efficacy of duloxetine 60 mg once-daily versus escitalopram 10 mg once-daily and placebo during acute therapy
  • To compare the efficacy of duloxetine 60-120 mg once-daily versus escitalopram 10-20 mg once-daily and placebo for up to 8 months of therapy
  • To compare incidence of sexual dysfunction (defined by Changes in Sexual Functioning Questionnaire (CSFQ)), during acute therapy for patients treated with duloxetine 60 mg once-daily versus escitalopram 10 mg once-daily & placebo.
  • To compare sexual dysfunction during up to 8 months of treatment with duloxetine 60-120 mg once-daily versus escitalopram 10 to 20 mg once-daily and placebo
  • To compare impact of duloxetine 60 mg once-daily versus escitalopram 10 mg once-daily & placebo during acute therapy & during 8 months of therapy on quality of life, functional/health outcomes, & patient satisfaction with study drug
  • To compare impact of duloxetine 60-120 mg once-daily versus escitalopram 10 to 20 mg once-daily and placebo for up to 8 months of therapy on quality of life, functional/health outcomes, & patient satisfaction with study drug
  • To compare impact of duloxetine 60-120 mg once-daily versus escitalopram 10-20 mg once-daily and placebo during acute and extended therapy on resource utilization (% patients using more,less or equal number of health care providers and services)
  • To evaluate safety and tolerability of duloxetine 60 mg once-daily vs. escitalopram 10 mg once-daily and placebo during acute therapy
  • To evaluate the safety and tolerability of duloxetine 60-120 mg once-daily vs. escitalopram 10-20 mg once-daily and placebo for up to 8 months of therapy
  • To compare percentage of patients taking duloxetine 60 mg once-daily versus escitalopram 10 mg once-daily and placebo requiring a dose escalation due to less than satisfactory initial response (defined by IRB supplement or investigator request)
  • To compare efficacy of duloxetine versus escitalopram in the placebo non-responders who enter the rescue phase

Estimated Enrollment:   675
Study Start Date:   November 2003
Study Completion Date:   May 2005

Detailed Description:

duloxetine 60mg - 120mg, escitalopram 10mg - 20mg, and placebo, 8-month,

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

Criteria

Inclusion Criteria:

  • Must be at least 18 of age
  • Must meet the criteria for major depressive disorder
  • You must be able to visit the doctor's office about once a week for 2 to 3 months. After that, you will need to visit the doctor's office once a month for about 6 months
  • You must be able to take the study drug as prescribed (6 capsules per day taken once-daily)

Exclusion Criteria:

  • You are a woman and are pregnant or breastfeeding.
  • You have a current or previous major psychiatric disorder other than depression, such as bipolar disorder, schizophrenia, or other psychotic disorder.
  • You have a history of alcohol or drug dependence within the past 6 months
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00073411

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

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


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

Publications indexed to this study:

Study ID Numbers:   7978, F1J-US-HMCR
First Received:   November 20, 2003
Last Updated:   July 30, 2007
ClinicalTrials.gov Identifier:   NCT00073411
Health Authority:   United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Dopamine Uptake Inhibitors
Parasympatholytics
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Cholinergic Antagonists
Adrenergic Uptake Inhibitors
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Psychotropic Drugs
Antiparkinson Agents
Cholinergic Agents
Serotonin Uptake Inhibitors
Pharmacologic Actions
Muscarinic Antagonists
Serotonin Agents
Autonomic Agents
Therapeutic Uses
Dopamine Agents
Peripheral Nervous System Agents
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on October 10, 2008




Links to all studies - primarily for crawlers