- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02694328
A Study of ALKS 3831 in Adults With Schizophrenia (The ENLIGHTEN-2 Study)
January 29, 2020 updated by: Alkermes, Inc.
A Phase 3 Study to Evaluate Weight Gain of ALKS 3831 Compared to Olanzapine in Adults With Schizophrenia
This study will evaluate weight gain of ALKS 3831 compared to olanzapine in adult subjects with schizophrenia.
Study Overview
Study Type
Interventional
Enrollment (Actual)
561
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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San Juan, Puerto Rico, 00918
- Alkermes Investigational Site
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San Juan, Puerto Rico, 00926
- Alkermes Investigational Site
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Arkansas
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Little Rock, Arkansas, United States, 72211
- Alkermes Investigational Site
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Springdale, Arkansas, United States, 72764
- Alkermes Investigational Site
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California
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Anaheim, California, United States, 92805
- Alkermes Investigational Site
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Cerritos, California, United States, 90703
- Alkermes Investigational Site
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Culver City, California, United States, 90230
- Alkermes Investigational Site
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Garden Grove, California, United States, 92845
- Alkermes Investigational Site
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Glendale, California, United States, 91206
- Alkermes Investigational Site
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Long Beach, California, United States, 90822
- Alkermes Investigational Site
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National City, California, United States, 91950
- Alkermes Investigational Site
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Oakland, California, United States, 94612
- Alkermes Investigational Site
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Oceanside, California, United States, 92056
- Alkermes Investigational Site
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Orange, California, United States, 92868
- Alkermes Investigational Site
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Pico Rivera, California, United States, 90660
- Alkermes Investigational Site
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Redlands, California, United States, 92374
- Alkermes Investigational Site
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San Diego, California, United States, 92123
- Alkermes Investigational Site
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San Diego, California, United States, 92103
- Alkermes Investigational Site
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Temecula, California, United States, 92591
- Alkermes Investigational Site
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Torrance, California, United States, 90502
- Alkermes Investigational Site
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District of Columbia
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Washington, District of Columbia, United States, 20016
- Alkermes Investigational Site
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Florida
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Lauderhill, Florida, United States, 33319
- Alkermes Investigational Site
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Miami, Florida, United States, 33136
- Alkermes Investigational Site
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North Miami, Florida, United States, 33161
- Alkermes Investigational Site
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Oakland Park, Florida, United States, 33334
- Alkermes Investigational Site
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Tampa, Florida, United States, 33609
- Alkermes Investigational Site
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Georgia
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Atlanta, Georgia, United States, 30329
- Alkermes Investigational Site
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Augusta, Georgia, United States, 30912
- Alkermes Investigational Site
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Decatur, Georgia, United States, 30030
- Alkermes Investigational Site
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Illinois
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Chicago, Illinois, United States, 60640
- Alkermes Investigational Site
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Michigan
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Grand Rapids, Michigan, United States, 49503
- Alkermes Investigational Site
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Mississippi
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Flowood, Mississippi, United States, 39232
- Alkermes Investigational Site
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Missouri
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Creve Coeur, Missouri, United States, 63141
- Alkermes Investigational Site
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O'Fallon, Missouri, United States, 63368
- Alkermes Investigational Site
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Saint Louis, Missouri, United States, 63128
- Alkermes Investigational Site
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Nevada
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Las Vegas, Nevada, United States, 89102
- Alkermes Investigational Site
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New Jersey
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Berlin, New Jersey, United States, 08009
- Alkermes Investigational Site
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Marlton, New Jersey, United States, 08053
- Alkermes Investigational Site
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New York
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Brooklyn, New York, United States, 11235
- Alkermes Investigational Site
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Jamaica, New York, United States, 11432
- Alkermes Investigational Site
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New York, New York, United States, 10032
- Alkermes Investigational Site
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New York, New York, United States, 10035
- Alkermes Investigational Site
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Rochester, New York, United States, 14615
- Alkermes Investigational Site
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Wards Island, New York, United States, 10035
- Alkermes Investigational Site
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Ohio
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Canton, Ohio, United States, 44718
- Alkermes Investigational Site
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Dayton, Ohio, United States, 45417
- Alkermes Investigational Site
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Middleburg Heights, Ohio, United States, 44130
- Alkermes Investigational Site
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Pennsylvania
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Allentown, Pennsylvania, United States, 18104
- Alkermes Investigational Site
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Texas
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Austin, Texas, United States, 78754
- Alkermes Investigational Site
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Austin, Texas, United States, 78759
- Alkermes Investigational Site
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Dallas, Texas, United States, 75243
- Alkermes Investigational Site
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DeSoto, Texas, United States, 75115
- Alkermes Investigational Site
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Houston, Texas, United States, 77030
- Alkermes Investigational Site
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Washington
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Bellevue, Washington, United States, 98007
- Alkermes Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Subject has a body mass index (BMI) of 18.0-30.0 kg/m^2, inclusive, at Visit 1 and Visit 2
- Subject meets the DSM-5 criteria for a primary diagnosis of schizophrenia
- Subject is appropriate for outpatient treatment; has no hospitalizations for acute exacerbations of schizophrenia within 6 months before Visit 1
- Subject has maintained a stable body weight (change </= 5%) for at least 3 months prior to Visit 1 based on self-report
- Additional criteria may apply
Exclusion Criteria:
- Subject has any of the following psychiatric conditions per DSM-5 criteria:
- Diagnosis of schizoaffective disorder or bipolar I or II disorder, or current, untreated or unstable major depressive disorder
- Clinically significant cognitive difficulties present within the past 2 years that could interfere with participation in the study
- Drug-induced or toxic psychosis
- Any other psychiatric condition that could interfere with participation in the study
- Subject poses a current suicide risk at Visit 1 or Visit 2 in the opinion of the investigator
- Subject has inflammatory bowel disease or any other gastrointestinal disorder associated with weight loss, anorexia nervosa, or binge eating disorder
- Additional criteria may apply
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: ALKS 3831
Administered as a coated bilayer tablet
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Daily dosing
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Active Comparator: Olanzapine
Administered as a coated bilayer tablet
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Daily dosing
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Percent Change From Baseline in Body Weight at Week 24
Time Frame: Baseline and Week 24
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Baseline and Week 24
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Percentage of Participants With >/= 10% Weight Gain at Week 24
Time Frame: Baseline and Week 24
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Baseline and Week 24
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Percentage of Participants With >/= 7% Weight Gain at Week 24
Time Frame: Baseline and Week 24
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Baseline and Week 24
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Number of Participants Experiencing of Adverse Events (AEs)
Time Frame: 24 weeks
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24 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 2, 2016
Primary Completion (Actual)
November 7, 2018
Study Completion (Actual)
November 7, 2018
Study Registration Dates
First Submitted
February 24, 2016
First Submitted That Met QC Criteria
February 24, 2016
First Posted (Estimate)
February 29, 2016
Study Record Updates
Last Update Posted (Actual)
February 10, 2020
Last Update Submitted That Met QC Criteria
January 29, 2020
Last Verified
January 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Schizophrenia Spectrum and Other Psychotic Disorders
- Schizophrenia
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Autonomic Agents
- Peripheral Nervous System Agents
- Antiemetics
- Gastrointestinal Agents
- Antipsychotic Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Serotonin Uptake Inhibitors
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Serotonin Agents
- Olanzapine
Other Study ID Numbers
- ALK3831-A303
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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