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
Glendale, California
1970
mi
from 43215
Glendale, CA
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Anaheim, California 92805
1960
mi
from 43215
Anaheim, CA
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Atlanta, Georgia 30308
436
mi
from 43215
Atlanta, GA
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Augusta, Georgia 30912
452
mi
from 43215
Augusta, GA
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Austin, Texas 78731
1065
mi
from 43215
Austin, TX
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Bellevue, Washington 98007
2000
mi
from 43215
Bellevue, WA
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Berlin, New Jersey
429
mi
from 43215
Berlin, NJ
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Brooklyn, New York
480
mi
from 43215
Brooklyn, NY
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5274
mi
from 43215
Burgas,
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Canton, Ohio 44718
104
mi
from 43215
Canton, OH
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Cerritos, California 90703
1967
mi
from 43215
Cerritos, CA
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Chicago, Illinois 60611
274
mi
from 43215
Chicago, IL
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Culver City, California 90230
1982
mi
from 43215
Culver City, CA
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Dayton, Ohio 45417
69
mi
from 43215
Dayton, OH
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Decatur, Georgia 30030
433
mi
from 43215
Decatur, GA
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Desoto, Texas 75115
922
mi
from 43215
Desoto, TX
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Eugene, Oregon 97401
2055
mi
from 43215
Eugene, OR
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Flowood, Mississippi 39232
660
mi
from 43215
Flowood, MS
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Fort Worth, Texas 76104
938
mi
from 43215
Fort Worth, TX
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Garden Grove, California 92845
1967
mi
from 43215
Garden Grove, CA
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Kansas City, Missouri
618
mi
from 43215
Kansas City, MO
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Las Vegas, Nevada 89102
1759
mi
from 43215
Las Vegas, NV
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Lauderhill, Florida 33161
986
mi
from 43215
Lauderhill, FL
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Little Rock, Arkansas 72211
622
mi
from 43215
Little Rock, AR
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Long Beach, California 90822
1973
mi
from 43215
Long Beach, CA
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Marlton, New Jersey 08053
429
mi
from 43215
Marlton, NJ
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National City, California 91950
1949
mi
from 43215
National City, CA
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North Miami, Florida
986
mi
from 43215
North Miami, FL
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Oakland, California 94612
2098
mi
from 43215
Oakland, CA
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Oceanside, California 92056
1945
mi
from 43215
Oceanside, CA
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Orange, California 92868
1959
mi
from 43215
Orange, CA
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Palo Alto, California 84026
?
mi
from 43215
Palo Alto, CA
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Pico Rivera, California 90660
1966
mi
from 43215
Pico Rivera, CA
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Redlands, California
1915
mi
from 43215
Redlands, CA
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Richardson, Texas 75080
901
mi
from 43215
Richardson, TX
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Rochester, New York 14642
354
mi
from 43215
Rochester, NY
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Rogers, Arkansas 72758
652
mi
from 43215
Rogers, AR
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Saint Louis, Missouri 63104
394
mi
from 43215
Saint Louis, MO
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San Antonio, Texas
1138
mi
from 43215
San Antonio, TX
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Temecula, California
1929
mi
from 43215
Temecula, CA
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Torrance, California 90502
1980
mi
from 43215
Torrance, CA
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