TerminatedNCT02623504
DB/Maintenance of Equetro (Carbamazepine) in Children With Acute Manic or Mixed Bipolarity type I
Researchers are comparing Carbamazepine and placebo, tracking side effects to assess long-term safety in children and adolescents with bipolarity type I.
Medication studyAges 10–17United States
Understand this study
What is this study about?
Researchers are comparing Carbamazepine and placebo, tracking side effects to assess long-term safety in children and adolescents with bipolarity type I.
Who could participate?
Listed age limits: 10 years to 17 years.
- Listed locations
- Orlando and 3 more locationsSee all locations and recruitment
- Study phase
- Phase 4Usually happens after approval, to monitor real-world use, safety, and longer-term outcomes.
What to know before participating
A point to clarify
This summary does not cover all risks or eligibility requirements. What risks or changes to my care would apply to me?
Things to check before joining
Study start dateStarted: October 24, 2016
- Recruitment status
- Terminated
- Enrollment listed in the registry
- 17
- Sponsor
- Validus Pharmaceuticals
- Sponsor type
- Unknown or unclear
- Study type
- Drug
- Intervention type
- Drug
- Study phase
- Phase 4Usually happens after approval, to monitor real-world use, safety, and longer-term outcomes.
- Locations
- United States
- Age range
- From 10 Years to 17 Years
- Official registry ID
- NCT02623504
- Official title
Show the full official title
A Double Blind Study To Evaluate the Dose Tolerance and Safety of Equetro (Carbamazepine) Versus Placebo Followed by a Long-Term Maintenance in Children and Adolescents Aged 10-17 Years With Acute Manic or Mixed Bipolar I Disorder
Recruitment & locations
TerminatedThis badge reflects the study status reported by the registry. Check the registry for the latest information.
Orlando · Baltimore · St Louis
1 more locations
- Houston
Interested in joining this study?
Questions about this study
What is this study about?
Researchers are comparing Carbamazepine and placebo, tracking side effects to assess long-term safety in children and adolescents with bipolarity type I.
Who is behind this study?
The study sponsor is Validus Pharmaceuticals.
Does this study involve medication?
Yes. The study involves medication, including Carbamazepine and Placebo.
Who can participate?
Listed age limits: 10 years to 17 years.
Is this study still recruiting?
The registry lists this study as terminated.
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