Schizophrenia study: OLZ/SAM vs Olanzapine
Official title Study to Evaluate Weight Gain as Assessed by Change in BMI Z-score in Pediatric Subjects With Schizophrenia or Bipolar I Disorder
ClinicalTrials.gov ID: NCT05303064
What this study is testing
What is OLZ/SAM?
OLZ/SAM is an investigational fixed‑dose combination being studied as a potential treatment for schizophrenia. is designed to combine the antipsychotic effects of olanzapine with the opioid antagonist samidorphan to potentially reduce weight gain.
Also referred to as Alks 3831, Lybalvi.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to compare changes in body mass index (BMI) Z‑score between the two treatments.
- Who it's for
- Pediatric patients diagnosed with schizophrenia or bipolar I disorder.
- What's involved
- Participants will receive either OLZ/SAM or olanzapine and attend scheduled visits for medication administration and health assessments.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 10 to 17
You may be able to join if
- people aged 13 to 17 years with schizophrenia or aged 10 to 17 years with bipolar I disorder, diagnosed according to Diagnostic and Statistical...
- 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...
- Subject must not be a danger to self or others (per Investigator judgement)
You likely can't join if
- Subject presents with a major depressive episode(bipolar I disorder) or other neuropsychiatric diagnosis (according to DSM-5 criteria) including...
- Subject has a history of seizure disorder (exception: history of febrile seizures), severe head trauma with loss of consciousness within the 12...
- 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...
- 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)
See the full eligibility criteria
- people 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...
- 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...
- 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...
- 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...
- Subject has participated in a clinical study of an investigational product within the last 30 days prior to Screening
The study team makes the final eligibility decision.
Where it is enrolling
- Dothan, Alabama, United States
- Little Rock, Arkansas, United States
- Stanford, California, United States
- Washington D.C., District of Columbia, United States
- Miami Lakes, Florida, United States
- Decatur, Georgia, United States
- Chicago, Illinois, United States
- Indianapolis, Indiana, United States
- Saint Charles, Missouri, United States
- Lincoln, Nebraska, United States
- New York, New York, United States
- Cincinnati, Ohio, United States
- West Chester, Ohio, United States
- Richmond, Virginia, United States
- Everett, Washington, United States
- La Plata, Buenos Aires, Argentina
- Buenos Aires, Argentina
- Córdoba, Argentina
- Mendoza, Argentina
- Fortaleza, Ceará, Brazil
+ 12 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 10 years to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Dothan, Alabama, United States; Little Rock, Arkansas, United States; Stanford, California, United States; Washington D.C., District of Columbia, United States; Miami Lakes, Florida, United States; Decatur, Georgia, United States and 26 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.