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
Saint Louis, Missouri 63104
1573
mi
from 91732
Saint Louis, MO
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Anaheim, California 92805
18
mi
from 91732
Anaheim, CA
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Atlanta, Georgia 30308
1919
mi
from 91732
Atlanta, GA
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Augusta, Georgia 30912
2058
mi
from 91732
Augusta, GA
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Austin, Texas 78731
1212
mi
from 91732
Austin, TX
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Bellevue, Washington 98007
959
mi
from 91732
Bellevue, WA
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Berlin, New Jersey
2388
mi
from 91732
Berlin, NJ
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Brooklyn, New York
2436
mi
from 91732
Brooklyn, NY
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6712
mi
from 91732
Burgas,
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Canton, Ohio 44718
2047
mi
from 91732
Canton, OH
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Cerritos, California 90703
14
mi
from 91732
Cerritos, CA
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Chicago, Illinois 60611
1729
mi
from 91732
Chicago, IL
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Culver City, California 90230
22
mi
from 91732
Culver City, CA
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Dayton, Ohio 45417
1892
mi
from 91732
Dayton, OH
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Decatur, Georgia 30030
1924
mi
from 91732
Decatur, GA
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Desoto, Texas 75115
1223
mi
from 91732
Desoto, TX
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Eugene, Oregon 97401
740
mi
from 91732
Eugene, OR
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Flowood, Mississippi 39232
1611
mi
from 91732
Flowood, MS
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Fort Worth, Texas 76104
1195
mi
from 91732
Fort Worth, TX
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Garden Grove, California 92845
19
mi
from 91732
Garden Grove, CA
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Glendale, California
14
mi
from 91732
Glendale, CA
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Kansas City, Missouri
1341
mi
from 91732
Kansas City, MO
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Las Vegas, Nevada 89102
214
mi
from 91732
Las Vegas, NV
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Lauderhill, Florida 33161
2319
mi
from 91732
Lauderhill, FL
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Little Rock, Arkansas 72211
1463
mi
from 91732
Little Rock, AR
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Long Beach, California 90822
19
mi
from 91732
Long Beach, CA
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Marlton, New Jersey 08053
2388
mi
from 91732
Marlton, NJ
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National City, California 91950
110
mi
from 91732
National City, CA
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North Miami, Florida
2319
mi
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North Miami, FL
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Oakland, California 94612
351
mi
from 91732
Oakland, CA
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Oceanside, California 92056
73
mi
from 91732
Oceanside, CA
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Orange, California 92868
21
mi
from 91732
Orange, CA
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Palo Alto, California 84026
?
mi
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Palo Alto, CA
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Pico Rivera, California 90660
7
mi
from 91732
Pico Rivera, CA
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Redlands, California
47
mi
from 91732
Redlands, CA
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Richardson, Texas 75080
1226
mi
from 91732
Richardson, TX
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Rochester, New York 14642
2244
mi
from 91732
Rochester, NY
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Rogers, Arkansas 72758
1354
mi
from 91732
Rogers, AR
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San Antonio, Texas
1188
mi
from 91732
San Antonio, TX
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Temecula, California
63
mi
from 91732
Temecula, CA
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Torrance, California 90502
22
mi
from 91732
Torrance, CA
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