Compares weight change of two drugs in youths with schizophrenia or bipolar I disorder
Compares weight changes from OLZ/SAM and olanzapine in children with schizophrenia or bipolar I.
Key facts
- Who runs it
- Alkermes, Inc.
- Where
- Buenos Aires, Córdoba, La Plata, and Mendoza, ArgentinaSee the 4 sitesAlso in 4 other countries, 39 sites
- Trial code
- Registry title
- Study to Evaluate Weight Gain as Assessed by Change in BMI Z-score in Pediatric Subjects With Schizophrenia or Bipolar I Disorder
- Status
- Recruiting
- Phase
- Phase 3
- People taking part
- 220 people, planned
- Started
- 30 Jun 2022
- Planned end
- Sept 2026
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- OLZ/SAM
- Olanzapine
- Record updated
- 14 August 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for children and teenagers with schizophrenia or bipolar I disorder who can be treated as outpatients. It compares OLZ/SAM with olanzapine and checks weight gain.
- Age
- 13 to 17 years with schizophrenia; 10 to 17 years with bipolar I disorder.
- Sex
- All sexes can join.
- Disease stage
- Schizophrenia or bipolar I disorder, diagnosed by DSM-5 criteria. The person must be treatable as an outpatient and must not be a danger to self or others.
- Earlier treatment
- The person is now treated with olanzapine, or had an inadequate response to another antipsychotic. Olanzapine for 14 days or more in the month before screening is not allowed.
Main reasons for not taking part
- Major depressive episode or other psychiatric diagnosis, such as schizoaffective disorder
- Seizure disorder or other significant neurological condition
- Current suicide risk
- Diabetes, or HbA1c of 6% (42 mmol/mol) or more
- BMI percentile above the 98th or below the 5th
The registry criteria, word for word
Show all 17 criteriaShow less
Who can take part
- 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)
Who cannot take part
- 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 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 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
- 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 diagnosis of diabetes mellitus or presents with prediabetes lab results at Screening (hemoglobin A1c [HbA1c] >= 6%)
- 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 a BMI percentile >98th or <5th
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 10 and 17 years old?
Where in Argentina
Also in 4 other countries, 39 sites
- Buenos AiresHospital not named in the registryContact: Global Clinical ServicesTaking people
- CórdobaHospital not named in the registryContact: Global Clinical ServicesTaking people
- La Plata, Buenos AiresHospital not named in the registryContact: Global Clinical ServicesTaking people
- MendozaHospital not named in the registryContact: Global Clinical ServicesTaking people
About the trial
What the trial wants to find out
To compare changes in body mass index (BMI) Z-score following treatment with OLZ/SAM vs olanzapine
The 2 groups in the trial
- Group 1 OLZ/SAMTreatment being tested
Fixed dose combination of olanzapine and samidorphan
Treatment: OLZ/SAM
- Group 2 OlanzapineExisting treatment, for comparison
Fixed dose of olanzapine
Treatment: Olanzapine
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- 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)
- Plain-language title
- Compares weight change of two drugs in youths with schizophrenia or bipolar I disorderGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT05303064, who can take part
- Record updated
- 14 August 2026