A Safety Study in Participants With Major Depressive Disorder
NCT ID: NCT01155661
Last Updated: 2018-04-17
Study Results
Results available
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE3
Total Enrollment
608 participants
Study Classification
INTERVENTIONAL
Study Start Date
2010-10-31
Study Completion Date
2012-12-31
Brief Summary
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The primary objective of this study is to evaluate the long-term safety and tolerability of LY2216684 administered once daily (QD) in the adjunctive treatment with a selective serotonin reuptake inhibitor (SSRI) for up to approximately 1 year in participants with major depressive disorder (MDD) who are partial responders to their SSRI treatment.
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Detailed Description
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Conditions
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Depressive Disorder, Major
Study Design
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Allocation Method
NA
Intervention Model
SINGLE_GROUP
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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LY2216684 (edivoxetine) + SSRI
Group Type
EXPERIMENTAL
LY2216684 (edivoxetine)
Intervention Type
DRUG
12 to 18 milligrams (mg), administered orally, once daily for 54 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
SSRI
Intervention Type
DRUG
Participants should have been on their SSRI for at least 6 weeks prior and were to continue on their stable dose throughout the study.
Interventions
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LY2216684 (edivoxetine)
12 to 18 milligrams (mg), administered orally, once daily for 54 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
Intervention Type
DRUG
SSRI
Participants should have been on their SSRI for at least 6 weeks prior and were to continue on their stable dose throughout the study.
Intervention Type
DRUG
Other Intervention Names
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LY2216684
edivoxetine
Selective Serotonin Reuptake Inhibitor
Eligibility Criteria
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Inclusion Criteria
* Adults competent and able to give informed consent
* Women of child-bearing potential may participate but must test negative for pregnancy at the time of study entry; both women/men agree to use a reliable method of birth control
* Participants who are being treated with one of the following selective serotonin reuptake inhibitors (SSRIs): escitalopram, citalopram, sertraline, fluoxetine, paroxetine, and fluvoxamine; for at least 6 weeks prior to investigational product dispensing with at least the last 4 weeks at a stable, optimized dose
* Drug and dosage should be within the labeling guidelines for the specific country
* Meet criteria for Major Depressive Disorder (MDD), as defined by the Diagnostic and Statistical Manual, Fourth Edition, Text Revision (DSM-IV-TR) criteria
* Meet criteria for partial response, as defined by investigator's opinion that participant has experienced a minimal clinically meaningful improvement with SSRI
* Have a Grid Hamilton Rating Scale for Depression (GRID-HAMD17) total score greater than or equal to 16 at screening
* Have less than or equal to 75 percent improvement on the current SSRI at screening determined by the Massachusetts General Hospital Antidepressant Response Questionnaire (MGH-ATRQ)
* Women of child-bearing potential may participate but must test negative for pregnancy at the time of study entry; both women/men agree to use a reliable method of birth control
* Participants who are being treated with one of the following selective serotonin reuptake inhibitors (SSRIs): escitalopram, citalopram, sertraline, fluoxetine, paroxetine, and fluvoxamine; for at least 6 weeks prior to investigational product dispensing with at least the last 4 weeks at a stable, optimized dose
* Drug and dosage should be within the labeling guidelines for the specific country
* Meet criteria for Major Depressive Disorder (MDD), as defined by the Diagnostic and Statistical Manual, Fourth Edition, Text Revision (DSM-IV-TR) criteria
* Meet criteria for partial response, as defined by investigator's opinion that participant has experienced a minimal clinically meaningful improvement with SSRI
* Have a Grid Hamilton Rating Scale for Depression (GRID-HAMD17) total score greater than or equal to 16 at screening
* Have less than or equal to 75 percent improvement on the current SSRI at screening determined by the Massachusetts General Hospital Antidepressant Response Questionnaire (MGH-ATRQ)
Exclusion Criteria
* Presence of another primary psychiatric illnesses:
* Have had or currently have any additional ongoing DSM-IV-TR Axis I condition other than major depression within 1 year of screening
* Have had any anxiety disorder that was considered a primary diagnosis within the past year (including panic disorder, obsessive-compulsive disorder, post-traumatic stress disorder, generalized anxiety disorder, and social phobia, but excluding specific phobias)
* Have a current or previous diagnosis of a bipolar disorder, schizophrenia, or other psychotic disorder
* Have a history of substance abuse and/or dependence within the past 1 year (drug categories defined by DSM-IV-TR), not including caffeine and nicotine
* Have a DSM-IV-TR Axis II disorder that, in the judgment of the investigator, would interfere with compliance with protocol
* Unstable medical conditions that contraindicate the use of LY2216684
* Have any diagnosed medical condition which could be exacerbated by noradrenergic agents including unstable hypertension, unstable heart disease, tachycardia, tachyarrhythmia, narrow-angled glaucoma, urinary hesitation or retention
* Use of excluded concomitant or psychotropic medication other than SSRI
* Have initiated or discontinued hormone therapy within the previous 3 months of prior to enrollment
* History of treatment resistant depression as shown by:
* Have had lack of response of the current depressive episode to 2 or more adequate courses of antidepressant therapy at a clinically appropriate dose for at least 4 weeks, or in the judgment of the investigator, the participant has treatment-resistant depression
* Have a history of electroconvulsive therapy, transcranial magnetic stimulation, or psychosurgery within the last year
* Have had or currently have any additional ongoing DSM-IV-TR Axis I condition other than major depression within 1 year of screening
* Have had any anxiety disorder that was considered a primary diagnosis within the past year (including panic disorder, obsessive-compulsive disorder, post-traumatic stress disorder, generalized anxiety disorder, and social phobia, but excluding specific phobias)
* Have a current or previous diagnosis of a bipolar disorder, schizophrenia, or other psychotic disorder
* Have a history of substance abuse and/or dependence within the past 1 year (drug categories defined by DSM-IV-TR), not including caffeine and nicotine
* Have a DSM-IV-TR Axis II disorder that, in the judgment of the investigator, would interfere with compliance with protocol
* Unstable medical conditions that contraindicate the use of LY2216684
* Have any diagnosed medical condition which could be exacerbated by noradrenergic agents including unstable hypertension, unstable heart disease, tachycardia, tachyarrhythmia, narrow-angled glaucoma, urinary hesitation or retention
* Use of excluded concomitant or psychotropic medication other than SSRI
* Have initiated or discontinued hormone therapy within the previous 3 months of prior to enrollment
* History of treatment resistant depression as shown by:
* Have had lack of response of the current depressive episode to 2 or more adequate courses of antidepressant therapy at a clinically appropriate dose for at least 4 weeks, or in the judgment of the investigator, the participant has treatment-resistant depression
* Have a history of electroconvulsive therapy, transcranial magnetic stimulation, or psychosurgery within the last year
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Birmingham, Alabama, United States
Site Status
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Little Rock, Arkansas, United States
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Cerritos, California, United States
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Irvine, California, United States
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Los Alamitos, California, United States
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Redlands, California, United States
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Riverside, California, United States
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San Diego, California, United States
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Upland, California, United States
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Fort Walton Beach, Florida, United States
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Gainesville, Florida, United States
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Orlando, Florida, United States
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Indianapolis, Indiana, United States
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Prairie Village, Kansas, United States
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Boston, Massachusetts, United States
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Princeton, New Jersey, United States
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Albuquerque, New Mexico, United States
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Mount Kisco, New York, United States
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New York, New York, United States
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Rochester, New York, United States
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The Bronx, New York, United States
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Philadelphia, Pennsylvania, United States
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Dallas, Texas, United States
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San Antonio, Texas, United States
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Aparecida de Goiânia, , Brazil
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Belo Horizonte, , Brazil
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Botucatu, , Brazil
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Pelotas, , Brazil
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Ribeirão Preto, , Brazil
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Rio de Janeiro, , Brazil
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Salvador, , Brazil
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São Paulo, , Brazil
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Antofagasta, , Chile
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Santiago, , Chile
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Kaunas, , Lithuania
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Klaipėda, , Lithuania
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León, , Mexico
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Mazatlán, , Mexico
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Mexico City, , Mexico
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Monterrey, , Mexico
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San Luis Potosí City, , Mexico
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Villahermosa, , Mexico
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Zapopan, , Mexico
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Heerde, , Netherlands
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Wildervank, , Netherlands
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Alcalá de Henares, , Spain
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Madrid, , Spain
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Zamora, , Spain
Site Status
Countries
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United States
Brazil
Chile
Lithuania
Mexico
Netherlands
Spain
Other Identifiers
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H9P-MC-LNBO
Identifier Type: OTHER
Identifier Source: secondary_id
11318
Identifier Type: -
Identifier Source: org_study_id
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