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.
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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.
Contacts and locations
Locations
-
Alkermes Investigator Site
AVAILABLEMiami, Florida, 33126, United States
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