A Study of ALKS 3831 in Adults With Acute Exacerbation of Schizophrenia (the ENLIGHTEN-1 Study)
NCT ID: NCT02634346
Last Updated: 2018-06-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
403 participants
INTERVENTIONAL
2015-12-31
2017-06-07
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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ALKS 3831
Administered as a coated bilayer tablet
ALK3831
Daily dosing
Olanzapine
Administered as a coated bilayer tablet
Olanzapine
Daily dosing
Placebo
Administered as a coated bilayer tablet
Placebo
Daily dosing
Interventions
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ALK3831
Daily dosing
Olanzapine
Daily dosing
Placebo
Daily dosing
Eligibility Criteria
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Inclusion Criteria
* Meets criteria for the diagnosis of schizophrenia
* Resides in a stable living situation when not hospitalized
* Is willing and able to provide government-issued identification
* Additional criteria may apply
Exclusion Criteria
* Subject initiated first antipsychotic treatment within the past 12 months, or \<1 year has elapsed since the initial onset of active-phase of schizophrenia symptoms
* Subject poses a current suicide risk
* Subject has a history of treatment resistance
* Subject has a history of poor or inadequate response to treatment with olanzapine
* Subject requires or has had electroconvulsive therapy (ECT) treatment in the 2-month period prior to screening
* Subject has a diagnosis of moderate or severe alcohol or drug use disorder
* Subject has a positive urine drug screen for opioids, amphetamine/methamphetamine, phencyclidine, or cocaine at screening
* Additional criteria may apply
18 Years
70 Years
ALL
No
Sponsors
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Alkermes, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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David McDonnell, MD
Role: STUDY_DIRECTOR
Alkermes, Inc.
Locations
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Alkermes Investigational Site
Little Rock, Arkansas, United States
Alkermes Investigational Site
Springdale, Arkansas, United States
Alkermes Investigational Site
Culver City, California, United States
Alkermes Investigational Site
Garden Grove, California, United States
Alkermes Investigational Site
Lemon Grove, California, United States
Alkermes Investigational Site
Long Beach, California, United States
Alkermes Investigational Site
Orange, California, United States
Alkermes Investigational Site
San Diego, California, United States
Alkermes Investigational Site
Washington D.C., District of Columbia, United States
Alkermes Investigational Site
North Miami, Florida, United States
Alkermes Investigational Site
Chicago, Illinois, United States
Alkermes Investigational Site
St Louis, Missouri, United States
Alkermes Investigational Site
Las Vegas, Nevada, United States
Alkermes Investigational Site
Marlton, New Jersey, United States
Alkermes Investigational Site
Dayton, Ohio, United States
Alkermes Investigational Site
Dallas, Texas, United States
Alkermes Investigational Site
Burgas, , Bulgaria
Alkermes Investigational Site
Kazanlak, , Bulgaria
Alkermes Investigational Site
Lovech, , Bulgaria
Alkermes Investigational Site
Novi Iskar, , Bulgaria
Alkermes Investigational Site
Plovdiv, , Bulgaria
Alkermes Investigational Site
Veliko Tarnovo, , Bulgaria
Alkermes Investigational Site
Vratsa, , Bulgaria
Alkermes Investigational Site
Belgrade, , Serbia
Alkermes Investigational Site
Kragujevac, , Serbia
Alkermes Investigational Site
Novi Kneževac, , Serbia
Alkermes Investigational Site
Cherkasy, , Ukraine
Alkermes Investigational Site
Kherson, , Ukraine
Alkermes Investigational Site
Kiev, , Ukraine
Alkermes Investigational Site
Lviv, , Ukraine
Alkermes Investigational Site
Vinnytsia, , Ukraine
Countries
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References
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Potkin SG, Kunovac J, Silverman BL, Simmons A, Jiang Y, DiPetrillo L, McDonnell D. Efficacy and Safety of a Combination of Olanzapine and Samidorphan in Adult Patients With an Acute Exacerbation of Schizophrenia: Outcomes From the Randomized, Phase 3 ENLIGHTEN-1 Study. J Clin Psychiatry. 2020 Mar 3;81(2):19m12769. doi: 10.4088/JCP.19m12769.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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ALKS-3831-A305
Identifier Type: -
Identifier Source: org_study_id
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