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NCT05303064PHASE3Recruiting

Study to Evaluate Weight Gain as Assessed by Change in BMI Z-score in Pediatric Subjects With Schizophrenia or Bipolar I Disorder

Alkermes, Inc.

Start Date

6/30/2022

Completion Date

9/1/2026

Summary

To compare changes in body mass index (BMI) Z-score following treatment with OLZ/SAM vs olanzapine

Eligibility Criteria

Age Range: 10 years to 17 years

Inclusion Criteria: * Subjects aged 13 to 17 years with schizophrenia or aged 10 to 17 years with bipolar I disorder, diagnosed according to Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria * Subject is an outpatient or will be able to be treated on an outpatient basis (per Investigator judgement) by study Week 2 * Subject has reliable family/legal guardian support available for outpatient management * Subject is either currently treated with olanzapine, or if treated with another antipsychotic, the subject has had an inadequate response (eg, unsatisfactory clinical response, AEs, or nonadherence to current medication) based on Investigator judgment * Subject must not be a danger to self or others (per Investigator judgement) Exclusion Criteria: * Subject presents with a major depressive episode(bipolar I disorder) or other neuropsychiatric diagnosis (according to DSM-5 criteria) including schizoaffective disorder, current major depressive disorder that is untreated and/or unstable, or any other psychiatric condition that could interfere with participation in the study * Subject has a history of seizure disorder (exception: history of febrile seizures), severe head trauma with loss of consciousness within the 12 months prior to Screening, or other clinically significant neurological condition within the 12 months prior to Screening * Subject poses a current suicide risk as assessed by the Investigator or as confirmed by the baseline Columbia-Suicide Severity Rating Scale (C-SSRS) * Subject has received olanzapine for \>= 14 days during the month prior to screening, or has a history of poor or inadequate response to treatment with olanzapine * Subject has taken opioid agonists within 14 days prior to Screening, or within 30 days prior to Screening (for long-acting opioid agonists) * Subject anticipates needing to take opioid medication during the study period (eg, planned surgery, including oral surgery) * Subject has taken opioid antagonists including naltrexone (any formulation) or naloxone within 60 days prior to Screening * Subject has used a long-acting injectable antipsychotic medication within 3 injection cycles prior to Screening * Subject has a BMI percentile \>98th or \<5th * Subject has a diagnosis of diabetes mellitus or presents with prediabetes lab results at Screening (hemoglobin A1c \[HbA1c\] \>= 6%) * Subject has started a smoking cessation program within the 6 months prior to Screening or has joined a weight management program or has had significant changes in diet or exercise regimen within 6 weeks prior to Screening * Subject has participated in a clinical study of an investigational product within the last 30 days prior to Screening

Interventions

DRUG

OLZ/SAM

DRUG

Olanzapine

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Conditions

SchizophreniaBipolar I Disorder

Locations

Alkermes Investigator Site

Dothan, Alabama 36303

United States

Alkermes Investigator Site

Little Rock, Arkansas 72204

United States

Alkermes Investigator Site

Encino, California 91316

United States

Alkermes Investigator Site

Stanford, California 94305

United States

Alkermes Investigator Site

Upland, California 91786

United States

Alkermes Investigator Site

Colorado Springs, Colorado 80910

United States

Alkermes Investigator Site

Denver, Colorado 80202

United States

Alkermes Investigator Site

Hartford, Connecticut 06106

United States

Alkermes Investigator Site

Washington D.C., District of Columbia 20010

United States

Alkermes Investigator Site

Miami, Florida 33155

United States

Alkermes Investigator Site

Miami Lakes, Florida 33016

United States

Alkermes Investigator Site

Decatur, Georgia 30030

United States

Alkermes Investigator Site

Chicago, Illinois 60611

United States

Alkermes Investigator Site

Indianapolis, Indiana 46202

United States

Alkermes Investigator Site

Saint Charles, Missouri 63304

United States

Alkermes Investigator Site

Lincoln, Nebraska 68526

United States

Alkermes Investigator Site

Omaha, Nebraska 68198

United States

Alkermes Investigator Site

Paramus, New Jersey 07652

United States

Alkermes Investigator Site

New York, New York 10016

United States

Alkermes Investigational Site

Kinston, North Carolina 28504

United States

Alkermes Investigator Site

Cincinnati, Ohio 45219

United States

Alkermes Investigator Site

West Chester, Ohio 45069

United States

Alkermes Investigator Site

DeSoto, Texas 75115

United States

Alkermes Investigator Site

Fort Worth, Texas 76104

United States

Alkermes Investigational Site

Richmond, Virginia 23220

United States

Alkermes Investigator Site

Everett, Washington 98201

United States

Alkermes Investigator Site

La Plata, Buenos Aires 1900

Argentina

Alkermes Investigator Site

La Plata, Buenos Aires C1199ABB

Argentina

Alkermes Investigator Site

Buenos Aires, C1133AAH

Argentina

Alkermes Investigator Site

Córdoba, X5003DCE

Argentina

Alkermes Investigator Site

Mendoza, 5500

Argentina

Alkermes Investigator Site

Fortaleza, Ceará 60430-140

Brazil

Alkermes Investigator Site

Curitiba, Paraná 80240-280

Brazil

Alkermes Investigator Site

Goiânia, 74093-040

Brazil

Alkermes Investigator Site

Rio de Janeiro, 22270-060

Brazil

Alkermes Investigator Site

São Paulo, 01228-000

Brazil

Alkermes Investigator Site

São Paulo, 05403-010

Brazil

Alkermes Investigator Site

Barranquilla, 110121

Colombia

Alkermes Investigator Site

Bello, 51053

Colombia

Alkermes Investigator Site

Bogotá, 111166

Colombia

Alkermes Investigator Site

Bogotá, 80020

Colombia

Alkermes Investigator Site

Pereira, 660003

Colombia

Alkermes Investigator Site

Culiacán, 80230

Mexico

Alkermes Investigator Site

Estado de México, C.P. 07000

Mexico

Alkermes Investigator Site

León, 37000

Mexico

Alkermes Investigator Site

Monterrey, 64620

Mexico

Alkermes Investigator Site

Monterrey, 64710

Mexico