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Study ID: NCT05303064. We help you review the study, but cannot decide medical eligibility.
RecruitingNCT05303064
OLZ/SAM vs Olanzapine to Evaluate Weight Gain for schizophrenia
This study is recruiting in the United States, in Argentina, in Brazil, .... It is testing OLZ/SAM vs Olanzapine to Evaluate Weight Gain for schizophrenia.
Bipolarity, SchizophreniaDrugFrom 10 Years to 17 Years
Key information made simple
What is this study testing?
This study is testing whether OLZ/SAM may be useful for adolescents experiencing bipolarity.
What would participation involve?
Participants may receive OLZ/SAM, complete questionnaires or follow-up assessments, attend study visits with the research team. The protocol may also involve randomization, placebo, or a comparison group. The registry lists locations in Argentina, Brazil, Colombia.
Who is it mainly for?
This study appears to be mainly for adolescents with bipolarity. 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 placebo, randomization, or a comparison group, how many visits or travel steps are needed, what role parents or guardians have in the process.
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.
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?
Things to check before joining
Study start dateStarted: June 30, 2022
- Recruitment status
- Recruiting
- Estimated enrollment
- Not clearly listed
- 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
- NCT05303064
- 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)
- Official source
- Official registry link
Want help reviewing this study?
Study ID: NCT05303064. We help you review the study, but cannot decide medical eligibility.
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 Argentina.
Not medical advice
Information from public sources. Are you the study sponsor? Contact us to update this page: hi@hopestage.com
Questions about this study
What is this study trying to understand?
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. 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, Olanzapine. 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 bipolarity; age range: From 10 Years to 17 Years. The criteria appear fairly specific, 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. The listed contact or investigator is Alkermes, Inc., affiliated with Alkermes, Inc.. 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 registry indicates that this study is currently recruiting. This does not mean you are eligible: the study team must confirm the criteria, available locations, and next steps.
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