Duloxetine Compared to Escitalopram and Placebo in the Treatment of Patients With Depression - Full Text View

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 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	Duloxetine Versus Escitalopram and Placebo in the Treatment of Patients With Major Depression

Resource links provided by NLM:

MedlinePlus related topics: Depression

Drug Information available for: Citalopram hydrobromide Citalopram Duloxetine Duloxetine hydrochloride Escitalopram oxalate

U.S. FDA Resources

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

Additional Information:

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

No publications provided by Eli Lilly and Company

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Gueorguieva R, Mallinckrodt C, Krystal JH. Trajectories of depression severity in clinical trials of duloxetine: insights into antidepressant and placebo responses. Arch Gen Psychiatry. 2011 Dec;68(12):1227-37.

Sheehan DV, Harnett-Sheehan K, Spann ME, Thompson HF, Prakash A. Assessing remission in major depressive disorder and generalized anxiety disorder clinical trials with the discan metric of the Sheehan disability scale. Int Clin Psychopharmacol. 2011 Mar;26(2):75-83.

Prakash A, Risser RC, Mallinckrodt CH. The impact of analytic method on interpretation of outcomes in longitudinal clinical trials. Int J Clin Pract. 2008 Aug;62(8):1147-58. Epub 2008 Jun 28.

Pigott TA, Prakash A, Arnold LM, Aaronson ST, Mallinckrodt CH, Wohlreich MM. Duloxetine versus escitalopram and placebo: an 8-month, double-blind trial in patients with major depressive disorder. Curr Med Res Opin. 2007 Jun;23(6):1303-18. Epub 2007 Apr 27.

Nierenberg AA, Greist JH, Mallinckrodt CH, Prakash A, Sambunaris A, Tollefson GD, Wohlreich MM. Duloxetine versus escitalopram and placebo in the treatment of patients with major depressive disorder: onset of antidepressant action, a non-inferiority study. Curr Med Res Opin. 2007 Feb;23(2):401-16.

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

Additional relevant MeSH terms:

Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Dexetimide
Citalopram
Duloxetine
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Parasympatholytics
Autonomic Agents

Peripheral Nervous System Agents
Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Serotonin Agents
Adrenergic Uptake Inhibitors
Adrenergic Agents

ClinicalTrials.gov processed this record on June 17, 2013