A Study of ALKS 3831 in Adults With Schizophrenia (The ENLIGHTEN-2 Study)



Status:Completed
Conditions:Schizophrenia
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - 55
Updated:11/28/2018
Start Date:March 2, 2016
End Date:November 7, 2018

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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.


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 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
We found this trial at
50
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Wards Island, New York 10035
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Allentown, Pennsylvania 18104
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Allentown, PA
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Anaheim, California 92805
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Atlanta, Georgia 30308
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Atlanta, GA
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Augusta, Georgia 30912
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Austin, Texas 78731
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Bellevue, Washington 98007
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Berlin, New Jersey
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Berlin, NJ
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Brooklyn, New York
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Canton, Ohio 44718
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Cerritos, California 90703
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Chicago, Illinois 60611
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Chicago, IL
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Creve Coeur, Missouri 63141
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Culver City, California 90230
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Dallas, Texas 75231
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Dayton, Ohio 45417
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Decatur, Georgia 30030
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Decatur, GA
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Desoto, Texas 75115
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Flowood, Mississippi 39232
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Garden Grove, California 92845
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Glendale, California
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Grand Rapids, Michigan 49503
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Houston, Texas 77007
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Jamaica, New York
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Las Vegas, Nevada 89102
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Lauderhill, Florida 33161
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Little Rock, Arkansas 72211
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Long Beach, California 90822
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Marlton, New Jersey 08053
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Miami, Florida 33136
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Middleburg Heights, Ohio
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National City, California 91950
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New York, New York 10021
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North Miami, Florida
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O'Fallon, Missouri
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Oakland, California 94612
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Oakland Park, Florida 33334
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Oceanside, California 92056
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Orange, California 92868
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Pico Rivera, California 90660
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Redlands, California
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Rochester, New York 14642
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Saint Louis, Missouri 63104
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San Diego, California 92123
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Springdale, Arkansas 72764
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Temecula, California
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Torrance, California 90502
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Washington, District of Columbia 20016
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