A Study of ALKS 3831 in Adults With Acute Exacerbation of Schizophrenia (the ENLIGHTEN-1 Study)
A Phase 3 Study to Determine the Antipsychotic Efficacy and Safety of ALKS 3831 in Adult Subjects With Acute Exacerbation of Schizophrenia
1 other identifier
interventional
403
4 countries
31
Brief Summary
This study will evaluate the efficacy of ALKS 3831 in adult subjects with acute exacerbation of schizophrenia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 schizophrenia
Started Dec 2015
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2015
CompletedFirst Submitted
Initial submission to the registry
December 16, 2015
CompletedFirst Posted
Study publicly available on registry
December 18, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 25, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 7, 2017
CompletedResults Posted
Study results publicly available
June 27, 2018
CompletedJune 27, 2018
May 1, 2018
1.5 years
December 16, 2015
May 25, 2018
May 25, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 4
This scale consists of symptom constructs (7 positive, 7 negative, 16 general psychopathology), each to be rated on a 7-point Likert-type scale of severity with 1 being absent to 7 being extreme. Minimum scores (best outcome) equals 30 (total scale); maximum scores (worst outcome) equals 210 (total scale). Change is calculated between the baseline visit and Week 4.
4 weeks
Secondary Outcomes (2)
Change From Baseline in Clinical Global Impressions-Severity (CGIS) Score at Week 4
4 weeks
Incidence of Adverse Events
Approximately 4 weeks
Study Arms (3)
ALKS 3831
EXPERIMENTALAdministered as a coated bilayer tablet
Olanzapine
ACTIVE COMPARATORAdministered as a coated bilayer tablet
Placebo
PLACEBO COMPARATORAdministered as a coated bilayer tablet
Interventions
Eligibility Criteria
You may qualify if:
- Has a body mass index (BMI) of 18.0 - 40.0 kg/m\^2
- 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
You may not qualify if:
- Has had a psychiatric hospitalization for more than 30 days during the 90 days before screening
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Alkermes, Inc.lead
Study Sites (31)
Alkermes Investigational Site
Little Rock, Arkansas, 72211, United States
Alkermes Investigational Site
Springdale, Arkansas, 72764, United States
Alkermes Investigational Site
Culver City, California, 90230, United States
Alkermes Investigational Site
Garden Grove, California, 92845, United States
Alkermes Investigational Site
Lemon Grove, California, 91945, United States
Alkermes Investigational Site
Long Beach, California, 90822, United States
Alkermes Investigational Site
Orange, California, 92868, United States
Alkermes Investigational Site
San Diego, California, 92103, United States
Alkermes Investigational Site
Washington D.C., District of Columbia, 20016, United States
Alkermes Investigational Site
North Miami, Florida, 33161, United States
Alkermes Investigational Site
Chicago, Illinois, 60640, United States
Alkermes Investigational Site
St Louis, Missouri, 63141, United States
Alkermes Investigational Site
Las Vegas, Nevada, 89102, United States
Alkermes Investigational Site
Marlton, New Jersey, 08053, United States
Alkermes Investigational Site
Dayton, Ohio, 45417, United States
Alkermes Investigational Site
Dallas, Texas, 75243, 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
Related Publications (1)
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.
PMID: 32141723DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
The dose of olanzapine was not fixed and could be titrated during the first 2 weeks of the study.
Results Point of Contact
- Title
- Eva Stroynowski
- Organization
- Alkermes
Study Officials
- STUDY DIRECTOR
David McDonnell, MD
Alkermes, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 16, 2015
First Posted
December 18, 2015
Study Start
December 1, 2015
Primary Completion
May 25, 2017
Study Completion
June 7, 2017
Last Updated
June 27, 2018
Results First Posted
June 27, 2018
Record last verified: 2018-05