Efficacy and Safety study of Flexible Doses of Oral Ziprasidone in Children and Adolescents With Bipolarity type I
This study was terminated in the United States and in Ukraine. It focuses on Bipolarity.
Key information made simple
What is this study testing?
This study is testing whether Flexible Doses of Oral Ziprasidone may be useful for adolescents experiencing bipolarity.
What would participation involve?
Participants may receive Flexible Doses of Oral Ziprasidone, complete questionnaires or follow-up assessments, attend study visits with the research team. The registry lists locations in Ukraine and in the United States.
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 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 hospital, with sites including Harmonex Neuroscience Research, Inc in Dothan, Woodland International Research Group Inc in Little Rock, and Woodland International Research Group, LLC in Little Rock. Participation appears to involve a study treatment together with follow-up visits and routine safety or progress checks. Common reasons not to take part include 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
- Recruitment status
- Terminated
- Estimated enrollment
- Not clearly listed
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Sponsor type
- Other organization
- Study type
- Other
- Intervention type
- Other / unclear
- Study phase
- Not clearly listed
- Locations
- United States, Ukraine
- Age range
- From 10 Years to 17 Years
- Official registry ID
- NCT02075047
- Official title
- Efficacy and Safety Trial of Flexible Doses of Oral Ziprasidone in Children and Adolescents With Bipolarity type I
- Official source
- Official registry link
Want help reviewing this study?
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 Ukraine.
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 observational follow-up 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.
Why is the study type not clearly categorized?
The study type is not clearly categorized in the public registry. Focus on the objective, required tasks, visits, any intervention, and eligibility criteria, then ask the study team to confirm.
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 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?
The public registry does not clearly describe all participation steps. 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 risks or points should I check?
The public registry does not make the main risk category clear. Ask the study team what activities are required, what could feel uncomfortable, how safety is monitored, and what happens if you want to stop. 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 Pfizer's Upjohn has merged with Mylan to form Viatris 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 registry indicates that this study is not currently recruiting. Check the official registry for the reason and latest status.
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