Phase
Condition
Psychosis
Tourette's Syndrome
Schizotypal Personality Disorder (Spd)
Treatment
OLZ/SAM
Clinical Study ID
Ages 10-17 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Subject has completed the treatment period in either the ALKS 3831-A311 or the ALKS 3831-A312 study within 10 days of enrolling into this extension study, or subjecthad terminated early from Study ALKS 3831-A312 due to the clinically significantweight gain criterion.
Subject will benefit from continued therapy with OLZ/SAM per clinical judgment.
Subject is able to be treated on an outpatient basis.
Subject must not be a danger to self or others (per Investigator judgement) and hasfamily support available to be maintained as an outpatient.
Subject's parent(s)/legal guardian(s) is considered reliable by the Investigator andhas agreed to provide support to the subject to ensure compliance with studytreatment, visits, and protocol procedures.
Subject agrees to abide by the contraception requirements specified in the protocolfor the duration of the study.
Exclusion
Exclusion Criteria:
Subject poses a current suicide risk as assessed by the Investigator or as confirmedby the baseline Columbia-Suicide Severity Rating Scale by a response of "Yes" toquestion numbers 4 or 5 with ideation or suicidal behavior since the last visit.
Subject has any finding that in the view of the Investigator or Medical Monitorwould compromise the safety of the subject or affect their ability to fulfill theprotocol visit schedule or visit requirement.
Subject is currently taking medications that are contraindicated with olanzapine useor exhibit drug-interaction potential with olanzapine
Subject has a positive test for opioids.
Subject has a positive urine pregnancy test, is currently pregnant or breastfeeding,or plans to become pregnant or begin breastfeeding at any point during the study andfor 90 days after any study drug administration.
Study Design
Connect with a study center
Alkermes Investigational Site
Ciudad Autonoma de Buenos Aire, Buenos Aires C1181ACH
ArgentinaSite Not Available
Alkermes Investigational Site
La Plata, Buenos Aires 1900
ArgentinaSite Not Available
Alkermes Investigational Site
Ciudad de Cordoba, Cordoba 5000
ArgentinaSite Not Available
Alkermes Investigational Site
Córdoba, Cordoba 5004
ArgentinaSite Not Available
Alkermes Investigational Site
Ciudad de Mendoza, Mendoza 5500
ArgentinaSite Not Available
Alkermes Investigational Site
Ciudad Autonoma Buenos Aires, C1405BOA
ArgentinaSite Not Available
Alkermes Investigational Site
Ciudad Autonoma de Buenos Aires, C1133AAH
ArgentinaSite Not Available
Alkermes Investigational Site
Cordoba, X5003DCE
ArgentinaSite Not Available
Alkermes Investigational Site
Campbelltown, New South Wales 2560
AustraliaSite Not Available
Alkermes Investigational Site
Fortaleza, Ceará 60430-140
BrazilSite Not Available
Alkermes Investigational Site
Curitiba, Parana 80240-280
BrazilSite Not Available
Alkermes Investigational Site
Goiania, 74093-040
BrazilSite Not Available
Alkermes Investigational Site
Rio de Janeiro, 22270-060
BrazilSite Not Available
Alkermes Investigational Site
Sao Paulo, 01228-000
BrazilSite Not Available
Alkermes Investigational Site
São Paulo, 05403-010
BrazilSite Not Available
Alkermes Investigational Site
Barranquilla, 110121
ColombiaSite Not Available
Alkermes Investigational Site
Bello, 51053
ColombiaSite Not Available
Alkermes Investigational Site
Bogotá, 111166
ColombiaSite Not Available
Alkermes Investigational Site
Pereira, 660003
ColombiaSite Not Available
Alkermes Investigational Site
Johor Bahru, Johor 80100
MalaysiaSite Not Available
Alkermes Investigational Site
Sungai Petani, Kedah 8000
MalaysiaSite Not Available
Alkermes Investigational Site
Seremban, Negeri Sembilan 70300
MalaysiaSite Not Available
Alkermes Investigational Site
Kuala Lumpur, Putrajaya 50603
MalaysiaSite Not Available
Alkermes Investigational Site
Gustavo A. Madero, Estado de Mexico C.P. 07000
MexicoSite Not Available
Alkermes Investigational Site
León, Guanajuato 37000
MexicoSite Not Available
Alkermes Investigational Site
Guadalajara, Jalisco 44100
MexicoSite Not Available
Alkermes Investigational Site
Monterrey, Nuevo León 64710
MexicoSite Not Available
Alkermes Investigational Site
San Luis Potosí, San Luis Potos 78213
MexicoSite Not Available
Alkermes Investigational Site
Culiacán, Sinaloa 80230
MexicoSite Not Available
Alkermes Investigational Site
Durango, 34200
MexicoSite Not Available
Alkermes Investigational Site
Dothan, Alabama 36303
United StatesSite Not Available
Alkermes Investigator Site
Chandler, Arizona 84226
United StatesSite Not Available
Alkermes Investigational Site
Little Rock, Arkansas 72204
United StatesSite Not Available
Alkermes Investigational Site
Anaheim, California 92805
United StatesSite Not Available
Alkermes Investigational Site
Encino, California 91316
United StatesSite Not Available
Alkermes Investigational Site
Long Beach, California 90807
United StatesSite Not Available
Alkermes Investigational Site
Stanford, California 94305
United StatesSite Not Available
Alkermes Investigational Site
Upland, California 91786
United StatesSite Not Available
Alkermes Investigational Site
Colorado Springs, Colorado 80910
United StatesSite Not Available
Alkermes Investigational Site
Hartford, Connecticut 06106
United StatesSite Not Available
Alkermes Investigational Site
Washington, District of Columbia 20010
United StatesSite Not Available
Alkermes Investigational Site
Miami, Florida 33155
United StatesSite Not Available
Alkermes Investigational Site
Miami Lakes, Florida 33016
United StatesSite Not Available
Alkermes Investigational Site
Orlando, Florida 32803
United StatesSite Not Available
Alkermes Investigational Site
Decatur, Georgia 30030
United StatesSite Not Available
Alkermes Investigational Site
Chicago, Illinois 60611
United StatesSite Not Available
Alkermes Investigational Site
Indianapolis, Indiana 46202
United StatesSite Not Available
Alkermes Investigational Site
Kansas City, Kansas 66103
United StatesSite Not Available
Alkermes Investigational Site
Saint Charles, Missouri 63304
United StatesSite Not Available
Alkermes Investigational Site
Lincoln, Nebraska 68526
United StatesSite Not Available
Alkermes Investigational Site
Omaha, Nebraska 68131
United StatesSite Not Available
Alkermes Investigational Site
Neptune, New Jersey 07753
United StatesSite Not Available
Alkermes Investigational Site
Kinston, North Carolina 28501
United StatesSite Not Available
Alkermes Investigational Site
Cincinnati, Ohio 45229
United StatesSite Not Available
Alkermes Investigational Site
West Chester, Ohio 45069
United StatesSite Not Available
Alkermes Investigational Site
DeSoto, Texas 75115
United StatesSite Not Available
Alkermes Investigational Site
Fort Worth, Texas 76104
United StatesSite Not Available
Alkermes Investigational Site
Frisco, Texas 75034
United StatesSite Not Available
Alkermes Investigational Site
Richmond, Virginia 23220
United StatesSite Not Available
Alkermes Investigational Site
Everett, Washington 98201
United StatesSite Not Available
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