Key information made simple
This study is looking at care and outcomes for people with Schizophrenia or Bipolarity I. Taking part may give some people access to OLZ/SAM, but direct benefit is not guaranteed.
RecruitingNCT05303064
Study to Evaluate Weight Gain as Assessed by Change in BMI Z-score in Pediatric Subjects With Schizophrenia or Bipolarity type I
This study is recruiting. It focuses on bipolarity and currently lists participation information in the United States, Argentina, Brazil, Colombia, and Mexico.
BipolarityDrugFrom 10 Years to 17 Years
Your next step
The official record suggests in-person participation through a research setting, with sites including Alkermes Investigator Site in Dothan, Alkermes Investigator Site in Little Rock, and Alkermes Investigator Site in Encino. Participation appears to involve a study treatment together with follow-up visits and routine safety or progress checks. The main fit is usually meeting the main study requirements, while common reasons not to take part include major medical issues that could make participation unsuitable and safety concerns that need urgent care first. This is a later-stage study, which usually means a larger group and a closer look at how well the approach holds up.
Key study information
- Official title
- A Phase 3, Randomized, Double-Blind, 52-Week Study of OLZ/SAM vs Olanzapine to Evaluate Weight Gain as Assessed by Change in BMI Z-Score in Pediatric Subjects With Schizophrenia or Bipolar I Disorder (ENLIGHTEN-Youth)
- Condition
- Schizophrenia; Bipolar I Disorder
- Study status
- Recruiting
- Phase
- Phase 3
- Sponsor / lead affiliation
- Alkermes, Inc.
- Intervention
- OLZ/SAM, Olanzapine
- Location / country
- United States, Argentina, Brazil, Colombia, Mexico
- Contact
- Global Clinical Services
- clinicaltrials@alkermes.com
- Phone
- 888-235-8008 (US Only), 1-571-599-2702 (Global)
- Registry
- ClinicalTrials.gov
Why this study may matter
This study may matter because it is evaluating OLZ/SAM, Olanzapine in a structured research setting. For people exploring bipolarity research, clear information about the goal, status, contacts, and official source can support better questions before any decision.
Questions to ask before joining
- What are the exact eligibility criteria, and what could exclude someone?
- How many visits, assessments, or follow-ups are expected, and over what period?
- What risks, side effects, practical burdens, or alternatives should be understood first?
- Who should be contacted to confirm locations, timing, compensation, and next steps?
Registry reference
This page links back to the public source record so people can verify details directly with the registry and research team.
If you want the full study description, eligibility criteria, locations, and sponsor information in the original format, this is the place to check before taking the next step.
Open source recordAsk HopeStage to review this study with me
This form records your interest so HopeStage can follow up with practical guidance. It is not a medical eligibility decision and it does not guarantee a study spot.
Study reference: NCT05303064. We only ask for your email here. HopeStage can help you review the study, but this is not a medical eligibility decision.
For you
Taking part may give access to a new approach being evaluated.
It requires regular visits and structured follow-up.
Requires travel, with in-person participation in United States.
Not medical advice
Information from public sources. Are you the study sponsor? Contact us to update this page: hi@hopestage.com
Things to check before joining
- Sponsor
- Alkermes, Inc.
- Sponsor type
- Other organization
- Main activity
- medication or study treatment
- Intervention
- OLZ/SAM, Olanzapine
- Time commitment
- long follow-up or multiple visits
- Study phase
- Phase 3
- Enrollment
- Not available
- Recruitment status
- Recruiting
- Source
- Official registry link
Questions about this study
What is Study to Evaluate Weight Gain as Assessed by Change in BMI Z-score in Pediatric Subjects With Schizophrenia or Bipolarity type I?
This study is exploring medication or study treatment for people with bipolarity. Participants may complete study visits, assessments, or follow-up activities defined by the research team. Direct benefit is not guaranteed.
Who is behind this study, and what type of sponsor is it?
This study is sponsored by Alkermes, Inc.. Based on the sponsor name or official registry information, it appears to be another type of organization. You should verify the details in the official registry record.
What does participation involve, what phase is it, and what should I ask about safety?
This study may involve medication or study treatment, study visits, and assessments. The time commitment is long follow-up or multiple visits. The study phase is Phase 3. Earlier-phase studies are often more focused on safety, dose, or feasibility, while later-phase studies usually involve more participants and more information about the intervention. The official source record gives the most accurate details. Enrollment is not available in HopeStage data. HopeStage cannot say whether a study is safe or right for you. Before joining, ask the research team about possible risks, time commitment, visits, side effects, compensation, safety monitoring, and whether participation may affect your current care.
Where can I verify the study details?
Use the official source record linked on this page to check the full study description, recruitment status, eligibility criteria, locations, sponsor information, phase, enrollment, contact details, and any listed risks or requirements.