A Study of ALKS 3831 in Adults With Acute Exacerbation of Schizophrenia (the ENLIGHTEN-1 Study)



Status:Completed
Conditions:Schizophrenia
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - 70
Updated:6/29/2018
Start Date:December 2015
End Date:June 7, 2017

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A Phase 3 Study to Determine the Antipsychotic Efficacy and Safety of ALKS 3831 in Adult Subjects With Acute Exacerbation of Schizophrenia

This study will evaluate the efficacy of ALKS 3831 in adult subjects with acute exacerbation
of schizophrenia.


Inclusion Criteria:

- 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

Exclusion Criteria:

- 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
We found this trial at
17
sites
North Miami, Florida
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North Miami, FL
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Burgas,
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Chicago, Illinois 60611
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Chicago, IL
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Culver City, California 90230
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Culver City, CA
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Dallas, Texas 75231
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Dallas, TX
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Dayton, Ohio 45417
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Dayton, OH
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Garden Grove, California 92845
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Garden Grove, CA
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Las Vegas, Nevada 89102
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Las Vegas, NV
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Lemon Grove, California 91945
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Lemon Grove, CA
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Little Rock, Arkansas 72211
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Little Rock, AR
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Long Beach, California 90822
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Long Beach, CA
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Marlton, New Jersey 08053
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Marlton, NJ
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Orange, California 92868
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Orange, CA
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Saint Louis, Missouri 63104
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Saint Louis, MO
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San Diego, California 92123
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San Diego, CA
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Springdale, Arkansas 72764
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Springdale, AR
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Washington, District of Columbia 20016
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Washington,
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