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Enrolling By InvitationNCT04987229

Long-term Safety Extension Study of OLZ/SAM in Pediatric Subjects

This study is enrolling by invitation. It focuses on schizophrenia and currently lists participation information in Argentina, Brazil, Colombia, Mexico, and the United States.

Schizophrenia, BipolarityDrugFrom 10 Years to 17 Years

The public registry lists enrollment by invitation. This is not open recruitment; contact the research team to understand who may be invited.

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Then choose your country and confirm availability with each study site.

In plain English

Key information made simple

What is this study testing?

This study is testing whether OLZ/SAM may be useful for adolescents experiencing schizophrenia.

What would participation involve?

Participants may receive OLZ/SAM, attend study visits with the research team. The registry lists locations in Argentina, in Brazil, and in Colombia.

Who is it mainly for?

This study appears to be mainly for adolescents with schizophrenia. Because it involves minors, a parent or guardian may need to be involved.

What should you check before joining?

Ask about the dose, safety monitoring, and possible side effects, whether there is a comparison group, how many visits or travel steps are needed, what role parents or guardians have in the process.

Your next step

Check the study details

Check the official source, then confirm these points with the research team.

View official study record (opens in a new tab)

  • Recruitment and eligibility

    Is a site open, and who can take part?

  • Visits and time

    Where are visits, can any be remote, and how much time is needed?

  • Costs and support

    What costs, reimbursement or compensation apply?

Before joining

Questions to ask before joining

Study clarity

Things to check before joining

Study start dateStarted: October 22, 2021
Recruitment status
Enrolling By Invitation
Enrollment listed in the registry
236
Sponsor
Alkermes, Inc.
Sponsor type
Other organization
Study type
Drug
Intervention type
Medication / drug
Study phase
Phase 3Usually a larger study designed to confirm effectiveness and safety in a broader group.
Locations
United States, Argentina, Brazil, ...
Age range
From 10 Years to 17 Years
Official registry ID
NCT04987229
Official title
Long-term, Safety Extension Study of OLZ/SAM in Pediatric Subjects With Schizophrenia or Bipolar I Disorder

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Study ID: NCT04987229. We help you review the study, but cannot decide medical eligibility.

Check recruitment and locations

Recruitment checked against the registry by HopeStage on . Registry information can change. Always confirm availability with the research team.

View official study record (opens in a new tab)

The overall study status can differ from each site's status. Open a country to see its locations and their registry status.

Argentina · 5 sites
  • Alkermes Investigational Site
    Ciudad Autonoma de Buenos Aire, Buenos Aires
    Site status: Not listed — confirm with the team
  • Alkermes Investigational Site
    La Plata, Buenos Aires
    Site status: Not listed — confirm with the team
  • Alkermes Investigational Site
    Buenos Aires, Buenos Aires F.D.
    Site status: Not listed — confirm with the team
  • Alkermes Investigational Site
    Mendoza, Mendoza Province
    Site status: Not listed — confirm with the team
  • Alkermes Investigational Site
    Córdoba
    Site status: Not listed — confirm with the team
Brazil · 6 sites
  • Alkermes Investigational Site
    Fortaleza, Ceará
    Site status: Not listed — confirm with the team
  • Alkermes Investigational Site
    Curitiba, Paraná
    Site status: Not listed — confirm with the team
  • Alkermes Investigational Site
    Rio de Janeiro, Rio de Janeiro
    Site status: Not listed — confirm with the team
  • Alkermes Investigational Site
    São Paulo, São Paulo
    Site status: Not listed — confirm with the team
  • Alkermes Investigational Site
    Goiânia
    Site status: Not listed — confirm with the team
  • Alkermes Investigational Site
    São Paulo
    Site status: Not listed — confirm with the team
Colombia · 4 sites
  • Alkermes Investigational Site
    Barranquilla
    Site status: Not listed — confirm with the team
  • Alkermes Investigational Site
    Bello
    Site status: Not listed — confirm with the team
  • Alkermes Investigational Site
    Bogotá
    Site status: Not listed — confirm with the team
  • Alkermes Investigational Site
    Pereira
    Site status: Not listed — confirm with the team
Mexico · 5 sites
  • Alkermes Investigational Site
    León, Guanajuato
    Site status: Not listed — confirm with the team
  • Alkermes Investigational Site
    Monterrey, Nuevo León
    Site status: Not listed — confirm with the team
  • Alkermes Investigational Site
    Monterrey, Nuevo León
    Site status: Not listed — confirm with the team
  • Alkermes Investigational Site
    Culiacán, Sinaloa
    Site status: Not listed — confirm with the team
  • Alkermes Investigational Site
    Gustavo A. Madero, State of Mexico
    Site status: Not listed — confirm with the team
United States · 15 sites
  • Alkermes Investigational Site
    Dothan, Alabama
    Site status: Not listed — confirm with the team
  • Alkermes Investigational Site
    Little Rock, Arkansas
    Site status: Not listed — confirm with the team
  • Alkermes Investigational Site
    Stanford, California
    Site status: Not listed — confirm with the team
  • Alkermes Investigational Site
    Washington D.C., District of Columbia
    Site status: Not listed — confirm with the team
  • Alkermes Investigational Site
    Miami Lakes, Florida
    Site status: Not listed — confirm with the team
  • Alkermes Investigational Site
    Decatur, Georgia
    Site status: Not listed — confirm with the team
  • Alkermes Investigational Site
    Chicago, Illinois
    Site status: Not listed — confirm with the team
  • Alkermes Investigational Site
    Indianapolis, Indiana
    Site status: Not listed — confirm with the team
  • Alkermes Investigational Site
    Saint Charles, Missouri
    Site status: Not listed — confirm with the team
  • Alkermes Investigational Site
    Lincoln, Nebraska
    Site status: Not listed — confirm with the team
  • Alkermes Investigator Site
    New York, New York
    Site status: Not listed — confirm with the team
  • Alkermes Investigational Site
    Cincinnati, Ohio
    Site status: Not listed — confirm with the team
  • Alkermes Investigational Site
    West Chester, Ohio
    Site status: Not listed — confirm with the team
  • Alkermes Investigational Site
    Richmond, Virginia
    Site status: Not listed — confirm with the team
  • Alkermes Investigational Site
    Everett, Washington
    Site status: Not listed — confirm with the team
In practice

For you

Participation may contribute to research. Personal benefit is not guaranteed.

Ask the research team to explain the activities, time commitment, and follow-up involved.

Study sites are listed. Confirm the relevant site and any travel before making plans.

Important

Not medical advice

Information from public sources. Are you the study sponsor? Contact us to update this page: hi@hopestage.com

FAQ

Questions about this study

What is this study trying to understand?

This study is exploring medication or study treatment for people with schizophrenia. Participants may complete study visits, assessments, or follow-up activities defined by the research team. Direct benefit is not guaranteed. The detailed objective is not always clearly listed in the public registry; the study team can confirm.

Does this study involve a medication?

This appears to be a medication / drug study involving OLZ/SAM. Phase 3 studies are usually larger and aim to confirm effectiveness and safety in a broader group.

Who might this study be for?

This study may concern people with schizophrenia; age range: From 10 Years to 17 Years. The criteria appear fairly broad, but you should not assume you are eligible. The study team must confirm diagnosis, age, exclusions, available locations, and next steps.

What would I likely need to do?

You may need to take a study treatment and have regular medical follow-up. The listed study locations suggest that at least part of participation may involve a physical site. Ask whether some steps can be done remotely.

What side effects, interactions, or treatment changes should I check?

If the study involves a medication, ask whether it is already approved, experimental, or being tested for a new use. Check possible side effects, interactions with current treatment, dose changes, monitoring, and what happens if you feel worse. For any mental health study, also ask who to contact if you feel worse, whether participation may affect current treatment, whether you can stop, and who confirms eligibility.

Will I need to travel or attend in-person visits?

The listed study locations suggest that at least part of participation may involve a physical site. Ask which sites are open, how many visits are expected, whether any steps can be done remotely, and whether travel costs or compensation are listed.

Who is behind this study?

This study is sponsored by Alkermes, Inc., which appears to be another type of organization. If available, it can be useful to check the sponsor website, collaborators, investigator affiliation, and the official registry before deciding. HopeStage does not judge the quality of a sponsor or researcher, but helps you identify what to verify.

Can I still join this study?

The public registry lists enrollment by invitation. This is not open recruitment; contact the research team to understand who may be invited.

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