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

Schizophrenia Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05303064
• Other study ID #: ALKS 3831-A312
• Status: Recruiting
• Phase: Phase 3
• Start date: June 30, 2022
• Est. completion date: September 2026

Study information

• Verified date: April 2024
• Source: Alkermes, Inc.
• Contact: Global Clinical Services
• Phone: 888-235-8008 (US Only)
• Email: clinicaltrials[@]alkermes.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 220
• Est. completion date: September 2026
• Est. primary completion date: September 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Bipolar I Disorder
• Schizophrenia
• Weight Gain

Intervention

Drug:
• OLZ/SAM
OLZ/SAM refers to the fixed dose combination of olanzapine and samidorphan. The starting dose of olanzapine will be 2.5 mg/day or 5 mg/day at the discretion of the Investigator with a maximum daily dose of 20mg/day. The starting dose of samidorphan will be 5 or 10 mg.
• Olanzapine
The starting dose of olanzapine will be 2.5 mg/day or 5 mg/day at the discretion of the Investigator with a maximum daily dose of 20mg/day

Locations

Country	Name	City	State
Argentina	Alkermes Investigator Site	Ciudad Autonoma de Buenos Aires
Argentina	Alkermes Investigator Site	Ciudad de Cordoba
Argentina	Alkermes Investigator Site	Córdoba
Argentina	Alkermes Investigator Site	La Plata	Buenos Aires
Argentina	Alkermes Investigator Site	Mendoza
Brazil	Alkermes Investigator Site	Curitiba	Parana
Brazil	Alkermes Investigator Site	Fortaleza	Ceara
Brazil	Alkermes Investigator Site	Goiânia
Brazil	Alkermes Investigator Site	Rio De Janeiro
Brazil	Alkermes Investigator Site	Sao Paulo
Brazil	Alkermes Investigator Site	São Paulo
Colombia	Alkermes Investigator Site	Barranquilla
Colombia	Alkermes Investigator Site	Bello
Colombia	Alkermes Investigator Site	Bogotá
Colombia	Alkermes Investigator Site	Bogotá
Colombia	Alkermes Investigator Site	Pereira
Mexico	Alkermes Investigator Site	Culiacán
Mexico	Alkermes Investigator Site	Estado De México
Mexico	Alkermes Investigator Site	León
Mexico	Alkermes Investigator Site	Monterrey
Mexico	Alkermes Investigator Site	Monterrey
Mexico	Alkermes Investigator Site	San Luis Potosí
United States	Alkermes Investigator Site	Chicago	Illinois
United States	Alkermes Investigator Site	Cincinnati	Ohio
United States	Alkermes Investigator Site	Colorado Springs	Colorado
United States	Alkermes Investigator Site	Decatur	Georgia
United States	Alkermes Investigator Site	DeSoto	Texas
United States	Alkermes Investigator Site	Dothan	Alabama
United States	Alkermes Investigator Site	Encino	California
United States	Alkermes Investigator Site	Everett	Washington
United States	Alkermes Investigator Site	Fort Worth	Texas
United States	Alkermes Investigator Site	Hartford	Connecticut
United States	Alkermes Investigator Site	Indianapolis	Indiana
United States	Alkermes Investigator Site	Kansas City	Kansas
United States	Alkermes Investigator Site	Kinston	North Carolina
United States	Alkermes Investigator Site	Lincoln	Nebraska
United States	Alkermes Investigator Site	Miami	Florida
United States	Alkermes Investigator Site	Miami Lakes	Florida
United States	Alkermes Investigator Site	Omaha	Nebraska
United States	Alkermes Investigator Site	Saint Charles	Missouri
United States	Alkermes Investigator Site	Stanford	California
United States	Alkermes Investigator Site	Upland	California
United States	Alkermes Investigator Site	Washington	District of Columbia
United States	Alkermes Investigator Site	West Chester	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Alkermes, Inc.

Countries where clinical trial is conducted

United States,  Argentina,  Brazil,  Colombia,  Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in body mass index (BMI) Zscore at week 12	To compare changes in body mass index (BMI) Z-score following treatment with OLZ/SAM vs olanzapine	12 weeks
Secondary	Proportion of subjects with >=0.5 increase in BMI Z-score at Week 12	To compare subjects with clinical significant BMI Z-score increase with OLZ/SAM vs olanzapine	12 weeks
Secondary	Time to all-cause discontinuation of study drug over 52 weeks	To compare time to all-cause discontinuation of study drug with OLZ/SAM vs olanzapine	Up to 52 weeks
Secondary	Change from baseline in waist circumference	To compare the change from baseline in waist circumference with OLZ/SAM vs olanzapine	12 weeks
Secondary	Change from baseline in Positive and Negative Syndrome Scale (PANSS) total score for patients with schizophrenia by visit	To compare the change from baseline in Positive and Negative Syndrome Scale (PANSS) total score with OLZ/SAM vs olanzapine for patients with schizophrenia	12 weeks
Secondary	Change from baseline in Young Mania Rating Scale (YMRS) in patients with Bipolar I disorder	To compare the change from baseline in YMRS with OLZ/SAM vs olanzapine for patients with bipolar I disorder	12 weeks
Secondary	Change from baseline in Children's Depression Rating Scale-Revised (CDRS-R) for patients with bipolar I disorder by visit	To compare the change from baseline in CDRS-R with OLZ/SAM vs olanzapine for patients with bipolar I disorder	12 weeks
Secondary	Incidence of Adverse Events		Up to 52 weeks