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

NCT ID NCT04987229

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

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.

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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

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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