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Can a Two-Drug combo help teens with severe mental illness?

NCT ID NCT07744113

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access This study
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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.

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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.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

    AVAILABLE

    Miami, Florida, 33126, United States

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