Phase
Condition
Schizophrenia And Schizoaffective Disorders (Pediatric)
Schizophrenia And Schizoaffective Disorders
Mood Disorders
Treatment
N/AClinical Study ID
Ages 16-40 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Has less than 24 weeks previous treatment with antipsychotics (cumulative; lifetime)
- Subject treated with aripiprazole can receive an additional 1 year of treatmentat ≤5 mg/day, and this treatment will not be considered as part of the 24 weeksof previous treatment with antipsychotics
- Has less than 4 years elapse since the initial onset of active-phase of symptoms
- Has a body mass index (BMI) of <30 kg/m^2
- Agrees to use an acceptable method of contraception for the duration of the study andfor 30 days after the last dose of study drug
- Subject meets the criteria for a primary diagnosis of schizophrenia, schizophreniformdisorder, or bipolar I disorder
- For bipolar I disorder, must have been experiencing an episode of acute mania within ≤14 days prior to Visit 1
- Suitable for outpatient treatment
- Additional criteria may apply
Exclusion
Exclusion Criteria:
- Poses a current suicide risk
- Has a history of poor or inadequate response to treatment with olanzapine
- Has previously been treated with long-acting injectable antipsychotic medicationwithin the 2 months prior to screening, or has > 6 months cumulative life use, or hasreceived treatment with electroconvulsive therapy in their lifetime
- Has initiated treatment with mood stabilizers (eg lithium, valproate, etc) >2 monthsprior to Visit 1
- Has a positive drug screen for opioids, phencyclidine (PCP),amphetamine/methamphetamine, or cocaine
- Has taken opioid agonists (eg, codeine, oxycodone, tramadol, morphine) within the 14days prior to Visit 1, or has taken opioid antagonists, including naltrexone andnaloxone, within 60 days prior to Visit 1
- Taking any weight loss agents or hypoglycemic agents
- Has a clinically significant or unstable medical illness, condition, or disorder thatwould be anticipated to potentially compromise subject safety or adversely affect theevaluation of efficacy
- Has joined a weight management program or had significant changes in diet or exerciseregimen within the past 6 weeks
- Has started a smoking cessation program within the past 6 months
- Has a history of diabetes
- Currently pregnant or breastfeeding or is planning to become pregnant during the studyor within 30 days of the last study drug administration
- Additional criteria may apply
Study Design
Study Description
Connect with a study center
Alkermes Investigational Site
Vienna,
AustriaSite Not Available
Alkermes Investigational Site
Muenchen,
GermanySite Not Available
Alkermes Investigational Site
Galway,
IrelandSite Not Available
Alkermes Investigational Site
Jerusalem,
IsraelSite Not Available
Alkermes Investigational Site
Tel HaShomer,
IsraelSite Not Available
Alkermes Investigational Site
Brescia,
ItalySite Not Available
Alkermes Investigational Site
Naples,
ItalySite Not Available
Alkermes Investigational Site
Torino,
ItalySite Not Available
Alkermes Investigational Site
Busan,
Korea, Republic ofSite Not Available
Alkermes Investigational Site
Daegu,
Korea, Republic ofSite Not Available
Alkermes Investigational Site
Naju,
Korea, Republic ofSite Not Available
Alkermes Investigational Site
Seoul,
Korea, Republic ofSite Not Available
Alkermes Investigational Site
Poznań,
PolandSite Not Available
Alkermes Investigational Site
Warsaw,
PolandSite Not Available
Alkermes Investigational Site
Arkhangel'sk,
Russian FederationSite Not Available
Alkermes Investigational Site
Moscow,
Russian FederationSite Not Available
Alkermes Investigational Site
Roshchino,
Russian FederationSite Not Available
Alkermes Investigational Site
Rostov-on-Don,
Russian FederationSite Not Available
Alkermes Investigational Site
Saint Petersburg,
Russian FederationSite Not Available
Alkermes Investigational Site
Samara,
Russian FederationSite Not Available
Alkermes Investigational Site
Saratov,
Russian FederationSite Not Available
Alkermes Investigational Site
Tonnel'nyy,
Russian FederationSite Not Available
Alkermes Investigational Site
Oviedo,
SpainSite Not Available
Alkermes Investigational Site
Santander,
SpainSite Not Available
Alkermes Investigational Site
Kharkiv,
UkraineSite Not Available
Alkermes Investigational Site
Kyiv,
UkraineSite Not Available
Alkermes Investigational Site
Lviv,
UkraineSite Not Available
Alkermes Investigational Site
Poltava,
UkraineSite Not Available
Alkermes Investigational Site
Smila,
UkraineSite Not Available
Alkermes Investigational Site
Stepanovka,
UkraineSite Not Available
Alkermes Investigational Site
Guildford,
United KingdomSite Not Available
Alkermes Investigational Site
Headington,
United KingdomSite Not Available
Alkermes Investigational Site
London,
United KingdomSite Not Available
Alkermes Investigational Site
Maidstone,
United KingdomSite Not Available
Alkermes Investigational Site
Little Rock, Arkansas 72211
United StatesSite Not Available
Alkermes Investigational Site
Rogers, Arkansas 72758
United StatesSite Not Available
Alkermes Investigational Site
Garden Grove, California 92845
United StatesSite Not Available
Alkermes Investigational Site
National City, California 91950
United StatesSite Not Available
Alkermes Investigational Site
San Diego, California 92013
United StatesSite Not Available
Alkermes Investigational Site
Stanford, California 94305
United StatesSite Not Available
Alkermes Investigational Site
Jacksonville, Florida 32209
United StatesSite Not Available
Alkermes Investigational Site
North Miami, Florida 33161
United StatesSite Not Available
Alkermes Investigational Site
West Palm Beach, Florida 33407
United StatesSite Not Available
Alkermes Investigational Site
Atlanta, Georgia 30303
United StatesSite Not Available
Alkermes Investigational Site
Augusta, Georgia 30912
United StatesSite Not Available
Alkermes Investigational Site
Chicago, Illinois 60611
United StatesSite Not Available
Alkermes Investigational Site
Hoffman Estates, Illinois 60169
United StatesSite Not Available
Alkermes Investigational Site
Winfield, Illinois 60190
United StatesSite Not Available
Alkermes Investigational Site
Iowa City, Iowa 52242
United StatesSite Not Available
Alkermes Investigational Site
Kalamazoo, Michigan 49001
United StatesSite Not Available
Alkermes Investigational Site
Muskegon, Michigan 49442
United StatesSite Not Available
Alkermes Investigational Site
Kansas City, Missouri 64108
United StatesSite Not Available
Alkermes Investigational Site
Saint Louis, Missouri 63110
United StatesSite Not Available
Alkermes Investigational Site
Las Vegas, Nevada 89102
United StatesSite Not Available
Alkermes Investigational Site
Marlton, New Jersey 08053
United StatesSite Not Available
Alkermes Investigational Site
Durham, North Carolina 27707
United StatesSite Not Available
Alkermes Investigational Site
Cincinnati, Ohio 45219
United StatesSite Not Available
Alkermes Investigational Site
Eugene, Oregon 97401
United StatesSite Not Available
Alkermes Investigational Site
Austin, Texas 78754
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
Houston, Texas 77030
United StatesSite Not Available
Alkermes Investigational Site
Richardson, Texas 75080
United StatesSite Not Available
Alkermes Investigational Site
San Antonio, Texas 78201
United StatesSite Not Available
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