RECRUITING

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

Conditions

Schizophrenia Bipolar I Disorder LYBALVI Pediatric Olanzapine Samidorphan

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

A Phase 3, Randomized, Double-Blind, 52-Week Study of OLZ/SAM Vs Olanzapine to Evaluate Weight Gain As Assessed by Change in BMI Z-Score in Pediatric Subjects with Schizophrenia or Bipolar I Disorder (ENLIGHTEN-Youth)

Quick Facts

Study Start:2022-06-30

Study Completion:2026-09

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05303064

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:10 Years to 17 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD

Inclusion Criteria	Exclusion 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)	* 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

Inclusion Criteria

Exclusion 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)

* 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

Contacts and Locations

Study Contact

Global Clinical Services

CONTACT

888-235-8008 (US Only)

clinicaltrials@alkermes.com

Global Clinical Services

CONTACT

1-571-599-2702 (Global)

clinicaltrials@alkermes.com

Principal Investigator

David McDonnell, MD

STUDY_DIRECTOR

Alkermes, Inc.

Study Locations (Sites)

Alkermes Investigator Site

Dothan, Alabama, 36303

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

Hartford, Connecticut, 06106

United States

Alkermes Investigator Site

Washington, District of Columbia, 20010

United States

Alkermes Investigator Site

Miami Lakes, Florida, 33016

United States

Alkermes Investigator Site

Miami, Florida, 33155

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 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 Investigator Site

Everett, Washington, 98201

United States

Collaborators and Investigators

Sponsor: Alkermes, Inc.

David McDonnell, MD, STUDY_DIRECTOR, Alkermes, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-06-30

Study Completion Date2026-09

Study Record Updates

Study Start Date2022-06-30

Study Completion Date2026-09

Terms related to this study

Keywords Provided by Researchers

LYBALVI
Schizophrenia
Bipolar I Disorder
Pediatric
Olanzapine
Samidorphan

Additional Relevant MeSH Terms

Schizophrenia
Bipolar I Disorder