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A Study Comparing the Efficacy and Safety of Duloxetine and Placebo for the Treatment of Depression in Elderly Patients

NCT ID: NCT00406848

Last Updated: 2010-09-29

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

370 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Study Completion Date

2009-11-30

Brief Summary

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The purpose of this study is to compare the efficacy and safety of duloxetine 60 mg once daily to placebo on depression in elderly patients (greater than or equal to 65 years of age). Patients who do not respond in the first 13 weeks will be eligible for rescue using pre-defined criteria. Patients randomized to duloxetine 60 mg/day meeting the rescue criteria will be increased to 120 mg/day. Patients randomized to the placebo arm meeting the rescue criteria will be assigned to duloxetine 60 mg/day.

Detailed Description

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Conditions

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Major Depressive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Duloxetine

Group Type EXPERIMENTAL

duloxetine hydrochloride

Intervention Type DRUG

Placebo for 1 week (double-blind placebo lead-in), then duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity.

Placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity.

Interventions

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duloxetine hydrochloride

Placebo for 1 week (double-blind placebo lead-in), then duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity.

Intervention Type DRUG

placebo

Placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity.

Intervention Type DRUG

Other Intervention Names

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LY248686, Cymbalta

Eligibility Criteria

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Inclusion Criteria

* Are male or female outpatients at least 65 years of age who meet the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition Text Revision (DSM-IV-TR) diagnostic criteria for Major Depressive Disorder (MDD)
* Have a Mini Mental Score Exam (MMSE) score of at least 20 at Visit 1
* Have a degree of understanding such that the patient can communicate intelligibly with the investigator and study coordinator

Exclusion Criteria

* Patients judged clinically to be at serious suicidal risk in the opinion of the investigator
* Have any prior history of bipolar disorder, panic disorder, psychosis, schizophrenia, or obsessive-compulsive disorder
* Have any current (within the past 12 months) DSM-IV-TR primary Axis I diagnosis other than MDD
* Have moderate to severe dementia
* Have a serious medical illness, including any cardiovascular (CV), hepatic, renal, respiratory, hematologic, endocrinologic, or neurologic disease, or clinically significant laboratory abnormality that is not stabilized or is anticipated to require hospitalization within 6 months, in the opinion of the investigator
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role collaborator

Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Eli Lilly

Principal Investigators

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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM to 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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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.

Pasadena, California, United States

Site Status

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Sherman Oaks, California, United States

Site Status

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Hamden, Connecticut, United States

Site Status

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Coral Springs, Florida, United States

Site Status

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West Palm Beach, Florida, United States

Site Status

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Atlanta, Georgia, United States

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Hoffman Estates, Illinois, United States

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Lake Charles, Louisiana, United States

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Gaithersburg, Maryland, United States

Site Status

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Glen Burnie, Maryland, United States

Site Status

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Fall River, Massachusetts, United States

Site Status

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Nashua, New Hampshire, United States

Site Status

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Toms River, New Jersey, United States

Site Status

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Olean, New York, United States

Site Status

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Staten Island, New York, United States

Site Status

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Oklahoma City, Oklahoma, United States

Site Status

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Philadelphia, Pennsylvania, United States

Site Status

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Lincoln, Rhode Island, United States

Site Status

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Bartlett, Tennessee, United States

Site Status

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Memphis, Tennessee, United States

Site Status

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Wichita Falls, Texas, United States

Site Status

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Charleston, West Virginia, United States

Site Status

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Brown Deer, Wisconsin, United States

Site Status

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Arcachon, , France

Site Status

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Douai, , France

Site Status

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Limoges, , France

Site Status

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Metz, , France

Site Status

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Nice, , France

Site Status

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Strasbourg, , France

Site Status

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Valence, , France

Site Status

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Mexico City, , Mexico

Site Status

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.

Monterrey, , Mexico

Site Status

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Ponce, , Puerto Rico

Site Status

Countries

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United States France Mexico Puerto Rico

References

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Harada E, Kato M, Fujikoshi S, Wohlreich MM, Berggren L, Tokuoka H. Changes in energy during treatment of depression: an analysis of duloxetine in double-blind placebo-controlled trials. Int J Clin Pract. 2015 Oct;69(10):1139-48. doi: 10.1111/ijcp.12658. Epub 2015 May 16.

Reference Type DERIVED
PMID: 25980552 (View on PubMed)

Nelson JC, Oakes TM, Liu P, Ahl J, Bangs ME, Raskin J, Perahia DG, Robinson MJ. Assessment of falls in older patients treated with duloxetine: a secondary analysis of a 24-week randomized, placebo-controlled trial. Prim Care Companion CNS Disord. 2013;15(1):PCC.12m01419. doi: 10.4088/PCC.12m01419. Epub 2012 Jan 3.

Reference Type DERIVED
PMID: 23724353 (View on PubMed)

Oakes TM, Katona C, Liu P, Robinson M, Raskin J, Greist JH. Safety and tolerability of duloxetine in elderly patients with major depressive disorder: a pooled analysis of two placebo-controlled studies. Int Clin Psychopharmacol. 2013 Jan;28(1):1-11. doi: 10.1097/YIC.0b013e32835b09cd.

Reference Type DERIVED
PMID: 23138680 (View on PubMed)

Other Identifiers

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F1J-US-HMFA

Identifier Type: OTHER

Identifier Source: secondary_id

10815

Identifier Type: -

Identifier Source: org_study_id