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
Dallas, Texas 75231
341
mi
from
Dallas, TX
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5913
mi
from
Burgas,
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Chicago, Illinois 60611
610
mi
from
Chicago, IL
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Culver City, California 90230
1178
mi
from
Culver City, CA
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Dayton, Ohio 45417
741
mi
from
Dayton, OH
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Garden Grove, California 92845
1162
mi
from
Garden Grove, CA
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Las Vegas, Nevada 89102
963
mi
from
Las Vegas, NV
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Lemon Grove, California 91945
1135
mi
from
Lemon Grove, CA
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Little Rock, Arkansas 72211
372
mi
from
Little Rock, AR
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Long Beach, California 90822
1168
mi
from
Long Beach, CA
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Marlton, New Jersey 08053
1238
mi
from
Marlton, NJ
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North Miami, Florida
1316
mi
from
North Miami, FL
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Orange, California 92868
1154
mi
from
Orange, CA
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Saint Louis, Missouri 63104
418
mi
from
Saint Louis, MO
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San Diego, California 92123
1138
mi
from
San Diego, CA
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Springdale, Arkansas 72764
230
mi
from
Springdale, AR
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Washington, District of Columbia 20016
1127
mi
from
Washington,
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