Can a Two-Drug combo help teens with severe mental illness?
NCT ID NCT07744113
First seen Aug 04, 2026 · Last updated Aug 05, 2026 · Updated 1 time
Summary
This expanded access program offers continued treatment with OLZ/SAM, a combination of olanzapine and samidorphan, to adolescents with schizophrenia or bipolar I disorder who have already completed a year-long study of the drug. The goal is to provide ongoing access to the medication while monitoring its safety and effectiveness in a real-world outpatient setting. Participants must have family support and be able to be treated as outpatients.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- OLZ/SAM (olanzapine/samidorphan), a fixed-dose combination drug
- What this could lead to
- If successful, this program could offer a continued treatment option for adolescents with schizophrenia or bipolar I disorder, potentially improving symptom management and quality of life.
- What could go wrong
- This is an expanded access program, not a randomized trial, so it provides real-world data but no definitive efficacy conclusions. Risks include side effects from olanzapine, such as weight gain and metabolic changes.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
10 to 17 years
- Sex
-
Anyone
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * The Participant has completed 52-weeks on the ALKS 3831-A313 clinical study. * The Participant must not be a danger to self or others (per Investigator judgement) and has family support available to be maintained as an outpatient. * The Participant will benefit from continued therapy with OLZ/SAM per the clinical judgment of the Participant's Physician. * The Participant can be treated on an outpatient basis. * The Participant agrees to abide by the contraception requirements specified in the protocol for the duration of the study. * The Participant's parent(s)/legal guardian(s) is/are considered reliable by the Physician and has agreed to provide support to the subject to ensure compliance with study treatment, visits, and protocol procedures. Exclusion Criteria: * The participant is eligible for commercial OLZ/SAM (LYBALVI®) through standard commercial pathways (≥18) for approved use. * The participant is at a current risk of suicidal behavior as assessed by the Participant's Physician or answered "Yes" to questions 4 or 5 on the C-SSRS and/or had a suicide attempt within the past 12 months. * The participant has any finding that in the view of the Physician would compromise the safety of the Participant or affect their ability to fulfill the Program requirements. * The participant is currently taking medications that are contraindicated with olanzapine or OLZ/SAM use or exhibit drug interaction potential with olanzapine or OLZ/SAM (such as the Participant is currently using opioids or undergoing acute opioid withdrawal). * The participant has a positive test for opioids. * The participant is currently enrolled in an interventional clinical study or Early (or Expanded) Access Program (other than the OLZ/SAM Program) or used any investigational drug or device (other than the OLZ/SAM) within 30 days prior to starting the Program. * The participant has a positive urine pregnancy test, is currently pregnant or breastfeeding, or plans to become pregnant or begin breastfeeding at any point during the Program and for 90 days after any treatment with OLZ/SAM.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Bipolar 1 disorder are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Alkermes Investigator Site
AVAILABLEMiami, Florida, 33126, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a new drug ease schizophrenia symptoms in daily life?
- Mind over voices: brain training may quiet hallucinations
- Can a diabetes drug shield the hearts of people with schizophrenia?
- Blood test may spot schizophrenia early and guide treatment
- Head-to-Head: which drug tames mania best?
- Could a broccoli compound help schizophrenia symptoms?