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 Jun 27, 2026

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.

Disclaimer Read more

This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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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

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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, 111166, 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