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New combo pill tested for long-term safety in teens with mental health conditions

NCT ID NCT04987229

Disease control Sponsor: Alkermes, Inc. Source: ClinicalTrials.gov ↗

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 This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Aug 14, 2026 · Updated 1 time

Summary

This study is testing the long-term safety of a daily pill called OLZ/SAM (olanzapine plus samidorphan) in 236 teenagers with schizophrenia or bipolar I disorder. Participants have already completed a previous study with the same drug. The goal is to see if the drug is safe and tolerable over a longer period, with a focus on side effects like weight gain.

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 and samidorphan fixed-dose tablet)
What this could lead to
If successful, this could confirm that OLZ/SAM is a safe long-term treatment option for teens with schizophrenia or bipolar I disorder, potentially reducing weight gain side effects.
What could go wrong
This is an extension study focused on safety, not on how well the drug works. It only includes teens who already tolerated the drug in prior studies, so results may not apply to all patients. Weight gain and other side effects remain possible.

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.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 236 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2021

Expected to finish

Sep 2027

An estimate. End dates often move.

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

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * Subject has completed the treatment period in either the ALKS 3831-A311 or the ALKS 3831-A312 study within 10 days of enrolling into this extension study, or subject had terminated early from Study ALKS 3831-A312 due to the clinically significant weight gain criterion. * Subject will benefit from continued therapy with OLZ/SAM per clinical judgment. * Subject is able to be treated on an outpatient basis. * Subject must not be a danger to self or others (per Investigator judgement) and has family support available to be maintained as an outpatient. * Subject's parent(s)/legal guardian(s) is considered reliable by the Investigator and has agreed to provide support to the subject to ensure compliance with study treatment, visits, and protocol procedures. * Subject agrees to abide by the contraception requirements specified in the protocol for the duration of the study. Exclusion Criteria: * Subject poses a current suicide risk as assessed by the Investigator or as confirmed by the baseline Columbia-Suicide Severity Rating Scale by a response of "Yes" to question numbers 4 or 5 with ideation or suicidal behavior since the last visit. * Subject has any finding that in the view of the Investigator or Medical Monitor would compromise the safety of the subject or affect their ability to fulfill the protocol visit schedule or visit requirement. * Subject is currently taking medications that are contraindicated with olanzapine use or exhibit drug-interaction potential with olanzapine * Subject has a positive test for opioids. * Subject has a positive urine pregnancy test, is currently pregnant or breastfeeding, or plans to become pregnant or begin breastfeeding at any point during the study and for 90 days after any study drug administration.

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Conditions

The condition(s) this trial relates to.

bipolar I disorder schizophrenia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Bipolar I disorder Schizophrenia

How to take part

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

  1. The places running it

    35 sites in 5 countries. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    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 Investigational Site

    Dothan, Alabama, 36303, United States

  • Alkermes Investigational Site

    Little Rock, Arkansas, 72204, United States

  • Alkermes Investigational Site

    Stanford, California, 94305, United States

  • Alkermes Investigational Site

    Washington D.C., District of Columbia, 20010, United States

  • Alkermes Investigational Site

    Miami Lakes, Florida, 33016, United States

  • Alkermes Investigational Site

    Decatur, Georgia, 30030, United States

  • Alkermes Investigational Site

    Chicago, Illinois, 60611, United States

  • Alkermes Investigational Site

    Indianapolis, Indiana, 46202, United States

  • Alkermes Investigational Site

    Saint Charles, Missouri, 63304, United States

  • Alkermes Investigational Site

    Lincoln, Nebraska, 68526, United States

  • Alkermes Investigational Site

    Cincinnati, Ohio, 45229, United States

  • Alkermes Investigational Site

    West Chester, Ohio, 45069, United States

  • Alkermes Investigational Site

    Richmond, Virginia, 23220, United States

  • Alkermes Investigational Site

    Everett, Washington, 98201, United States

  • Alkermes Investigational Site

    Ciudad Autonoma de Buenos Aire, Buenos Aires, C1181ACH, Argentina

  • Alkermes Investigational Site

    La Plata, Buenos Aires, 1900, Argentina

  • Alkermes Investigational Site

    Buenos Aires, Buenos Aires F.D., C1133AAH, Argentina

  • Alkermes Investigational Site

    Mendoza, Mendoza Province, 5500, Argentina

  • Alkermes Investigational Site

    Córdoba, X5003DCE, Argentina

  • Alkermes Investigational Site

    Fortaleza, Ceará, 60430-140, Brazil

  • Alkermes Investigational Site

    Curitiba, Paraná, 80240-280, Brazil

  • Alkermes Investigational Site

    Rio de Janeiro, Rio de Janeiro, 22270-060, Brazil

  • Alkermes Investigational Site

    São Paulo, São Paulo, 05403-010, Brazil

  • Alkermes Investigational Site

    Goiânia, 74093-040, Brazil

  • Alkermes Investigational Site

    São Paulo, 01228-000, Brazil

  • Alkermes Investigational Site

    Barranquilla, 110121, Colombia

  • Alkermes Investigational Site

    Bello, 51053, Colombia

  • Alkermes Investigational Site

    Bogotá, 80020, Colombia

  • Alkermes Investigational Site

    Pereira, 660003, Colombia

  • Alkermes Investigational Site

    León, Guanajuato, 37000, Mexico

  • Alkermes Investigational Site

    Monterrey, Nuevo León, 64620, Mexico

  • Alkermes Investigational Site

    Monterrey, Nuevo León, 64710, Mexico

  • Alkermes Investigational Site

    Culiacán, Sinaloa, 80230, Mexico

  • Alkermes Investigational Site

    Gustavo A. Madero, State of Mexico, C.P. 07000, Mexico

  • Alkermes Investigator Site

    New York, New York, 10016, United States

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