A Study of Flexible or Fixed Dose LY2216684 as Adjunctive Treatment for Participants With Major Depressive Disorder Who Have Had a Partial Response to Selective Serotonin Reuptake Inhibitor (SSRI) Treatment
NCT ID: NCT01187407
Last Updated: 2018-04-24
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1480 participants
INTERVENTIONAL
2011-03-31
2013-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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12 or 18 mg flexible dose LY2216684 + SSRI
LY2216684: flexible dose of 12 or 18 milligrams (mg), administered orally, once daily (QD) for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
Prior to entering the Adjunctive Treatment (AT) Phase, participants completed a 3-week Confirmation (CF) Phase where they received placebo (orally, QD) adjunctive to their SSRI. After the CF Phase, and after randomization criteria were met, participants were randomized to a 12 or 18 mg flexible dose of LY2216684.
During the AT Phase, participants first received 6 mg LY2216684 QD for 3 days, followed by 12 mg QD for the next 11 days. Then, based on efficacy and tolerability, dosage could be increased to 18 mg QD over the next 6 weeks. Participants on 18 mg QD could have had their dose decreased back to 12 mg QD. Participants who completed the AT Phase or discontinued early had the option to enter the Discontinuation (DC) Phase.
During the 1-week abrupt DC Phase, participants maintained their SSRI treatment.
LY2216684
Placebo
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
6 mg fixed dose LY2216684 + SSRI
LY2216684: fixed dose of 6 mg, administered orally, QD for 8 weeks, adjunctive to an SSRI
Prior to entering the AT Phase, participants completed a 3-week CF Phase where they received placebo (orally, QD) adjunctive to their SSRI. After the CF Phase, and after randomization criteria were met, participants were randomized to 6 mg fixed dose of LY2216684.
During the AT Phase, participants received a 6 mg fixed dose of LY2216684 adjunctive to their SSRI for 8 weeks. Participants who completed the AT Phase or discontinued early had the option to enter the DC Phase.
During the 1-week abrupt DC Phase, participants maintained their SSRI treatment.
LY2216684
Placebo
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
Placebo + SSRI
Placebo: administered orally, QD for 8 weeks, adjunctive to an SSRI
Prior to entering the AT Phase, participants completed a 3-week CF Phase where they received placebo (orally, QD) adjunctive to their SSRI. After the CF Phase, and after randomization criteria were met, participants were randomized to placebo.
During the AT Phase, participants received placebo (administered orally, QD) adjunctive to their SSRI for 8 weeks. Participants who completed the AT Phase or discontinued early had the option to enter the DC Phase.
During the 1-week abrupt DC Phase, participants maintained their SSRI treatment.
Placebo
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
Interventions
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LY2216684
Placebo
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Using a reliable method of birth control
* Are taking a selective serotonin reuptake inhibitor (SSRI) approved for MDD treatment within the participant's country and the SSRI prescribed, including dose, should be consistent with labeling guidelines within the participating country
* Have a partial response to SSRI treatment
* Meet inclusion scores on pre-defined psychiatric scales to assess diagnosis of depression, disease severity, and response to SSRI treatment
* Reliable and able to keep all scheduled appointments
Exclusion Criteria
* Have had or currently have any additional ongoing Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) Axis 1 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 an Axis II disorder that, in the judgment of the investigator, would interfere with compliance with protocol
* Have any diagnosed medical condition that could be exacerbated by noradrenergic agents, including unstable hypertension, unstable heart disease, tachycardia, tachyarrhythmia, narrow-angle glaucoma, and history of 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 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 lifetime history of vagal nerve stimulation (VNS) transcranial magnetic stimulation (TMS), or psychosurgery
* Have received electroconvulsive therapy (ECT) in the past year
* Enrollment in a clinical study for an investigational drug
* Serious or unstable medical condition
* History of seizure disorders
* Have initiated psychotherapy, change in intensity of psychotherapy or other nondrug therapies (such as acupuncture or hypnosis) within 6 weeks prior to enrollment or any time during the study
* Participants who, in the opinion of the investigator, are judged to be at serious risk for harm to self or others
18 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Birmingham, Alabama, United States
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Phoenix, Arizona, United States
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Chino, California, United States
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Glendale, California, United States
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Imperial, California, United States
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National City, California, United States
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Sherman Oaks, California, United States
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Colorado Springs, Colorado, United States
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Clearwater, Florida, United States
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Coral Gables, Florida, United States
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Fort Lauderdale, Florida, United States
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Tampa, Florida, United States
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Atlanta, Georgia, United States
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Hoffman Estates, Illinois, United States
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Indianapolis, Indiana, United States
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Prairie Village, Kansas, United States
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Wichita, Kansas, United States
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Baltimore, Maryland, United States
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Haverhill, Massachusetts, United States
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Weymouth, Massachusetts, United States
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Flowood, Mississippi, United States
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O'Fallon, Missouri, United States
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Brooklyn, New York, United States
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New York, New York, United States
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Beachwood, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Philadelphia, Pennsylvania, United States
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Houston, Texas, United States
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Rab, , Croatia
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Zagreb, , Croatia
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Hořovice, , Czechia
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Hostivice, , Czechia
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Kladno, , Czechia
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Olomouc, , Czechia
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Prague, , Czechia
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Strakonice, , Czechia
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Ústí nad Labem, , Czechia
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Helsinki, , Finland
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Joensuu, , Finland
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Kuopio, , Finland
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Tampere, , Finland
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Turku, , Finland
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Chiba, , Japan
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Fukuoka, , Japan
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Fukushima, , Japan
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Hyōgo, , Japan
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Kanagawa, , Japan
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Tokyo, , Japan
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San Juan, , Puerto Rico
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Bratislava, , Slovakia
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Košice, , Slovakia
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Michalovce, , Slovakia
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Rimavská Sobota, , Slovakia
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Rožňava, , Slovakia
Countries
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References
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Stauffer VL, Liu P, Goldberger C, Marangell LB, Nelson C, Gorwood P, Fava M. Is the Noradrenergic Symptom Cluster a Valid Construct in Adjunctive Treatment of Major Depressive Disorder? J Clin Psychiatry. 2017 Mar;78(3):317-323. doi: 10.4088/JCP.15m09972.
Ball SG, Ferguson MB, Martinez JM, Pangallo BA, Nery ES, Dellva MA, Sparks J, Zhang Q, Liu P, Bangs M, Goldberger C. Efficacy outcomes from 3 clinical trials of edivoxetine as adjunctive treatment for patients with major depressive disorder who are partial responders to selective serotonin reuptake inhibitor treatment. J Clin Psychiatry. 2016 May;77(5):635-42. doi: 10.4088/JCP.14m09619.
Other Identifiers
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H9P-MC-LNBQ
Identifier Type: OTHER
Identifier Source: secondary_id
12182
Identifier Type: -
Identifier Source: org_study_id
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