Study to Evaluate the Long-term Safety, Tolerability, and Durability of Treatment Effect of ALKS 3831



Status:Enrolling by invitation
Conditions:Schizophrenia, Psychiatric, Bipolar Disorder
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:16 - 70
Updated:1/23/2019
Start Date:June 15, 2017
End Date:January 2021

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A Phase 3 Study to Assess the Long Term Safety, Tolerability, and Durability of Treatment Effect of ALKS 3831 in Subjects With Schizophrenia, Schizophreniform Disorder, or Bipolar I Disorder

This study will evaluate the long-term safety, tolerability, and durability of treatment
effect of ALKS 3831 in subjects with schizophrenia, schizophreniform disorder, or bipolar I
disorder


Inclusion Criteria:

- Willing and able to give informed consent/assent as per local requirements

- Agrees to use an acceptable method of contraception during the study, and for 30 days
after any study drug administration, unless surgically sterile or post-menopausal

- Has the potential to benefit from the administration of ALKS 3831, in the opinion of
the investigator

- Subject met the eligibility criteria of the antecedent study at the time of enrollment
in the antecedent study and completed the treatment period in one of the following
antecedent studies within 7 days: ALK3831-A304, ALK3831-A306, or ALK3831-A307

- Additional criteria may apply

Exclusion Criteria:

- Has any finding that, in the view of the investigator or medical monitor, would
compromise the safety of the subject or affect their ability to fulfill the protocol
visit schedule or visit requirements

- Has a positive drug screen for drugs of abuse at study entry

- Currently pregnant or breastfeeding or is planning to become pregnant during the study
or within 30 days of the last study drug administration

- Additional criteria may apply
We found this trial at
41
sites
Atlanta, Georgia 30308
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Anaheim, California 92805
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Anaheim, CA
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Augusta, Georgia 30912
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Augusta, GA
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Austin, Texas 78731
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Austin, TX
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Bellevue, Washington 98007
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Bellevue, WA
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Berlin, New Jersey
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Berlin, NJ
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Brooklyn, New York
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Brooklyn, NY
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Burgas,
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Canton, Ohio 44718
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Canton, OH
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Cerritos, California 90703
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Cerritos, CA
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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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Dayton, Ohio 45417
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Dayton, OH
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Decatur, Georgia 30030
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Decatur, GA
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Desoto, Texas 75115
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Desoto, TX
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Eugene, Oregon 97401
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Eugene, OR
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Flowood, Mississippi 39232
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Flowood, MS
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Fort Worth, Texas 76104
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Fort Worth, TX
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Garden Grove, California 92845
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Garden Grove, CA
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Glendale, California
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Glendale, CA
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Kansas City, Missouri
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Kansas City, MO
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Las Vegas, Nevada 89102
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Las Vegas, NV
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Lauderhill, Florida 33161
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Lauderhill, FL
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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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National City, California 91950
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National City, CA
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North Miami, Florida
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North Miami, FL
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Oakland, California 94612
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Oakland, CA
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Oceanside, California 92056
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Oceanside, CA
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Orange, California 92868
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Orange, CA
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Palo Alto, California 84026
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Palo Alto, CA
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Pico Rivera, California 90660
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Pico Rivera, CA
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Redlands, California
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Redlands, CA
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Richardson, Texas 75080
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Richardson, TX
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Rochester, New York 14642
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Rochester, NY
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Rogers, Arkansas 72758
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Rogers, AR
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Saint Louis, Missouri 63104
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Saint Louis, MO
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San Antonio, Texas
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San Antonio, TX
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Temecula, California
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Temecula, CA
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Torrance, California 90502
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Torrance, CA
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