A 52-week, Multicenter, Open-label Study to Evaluate the Effectiveness of an Intramuscular Depot Formulation of Aripiprazole (OPC-14597) as Maintenance Treatment in Patients with Bipolarity type I
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Understand this study
What did researchers investigate?
This EU register entry describes an interventional medicine trial, designed to assign participants a study treatment. The protocol sets out the treatment, eligibility criteria and assessments. Check the source details below for country statuses and any transfer to CTIS.
Who was this study for?
This study was for people with type I bipolarity. Other eligibility criteria applied.
- Listed locations
- Hungary
- Study phase
- Phase 3 / Phase 4This study spans more than one phase, so it may combine goals such as safety, dosing, and early effectiveness.
Study information
- Recruitment status
- Completed
- Enrollment listed in the registry
- 1,000
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- Sponsor type
- Pharmaceutical company
- Study type
- Drug
- Intervention type
- Medication / drug
- Study phase
- Phase 3, Phase 4This study spans more than one phase, so it may combine goals such as safety, dosing, and early effectiveness.
- Locations
- Hungary
- Age range
- Not clearly listed
- Official registry ID
- EUCTR 2012-004334-42
- Official title
Show the full official title
A 52-week, Multicenter, Open-label Study to Evaluate the Effectiveness of an Intramuscular Depot Formulation of Aripiprazole (OPC-14597) as Maintenance Treatment in Patients with Bipolar I Disorder
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Explore recruiting studiesRecruitment & locations
Hungary
Registry details
- Hungary — Completed
Questions about this study
Who is behind this study?
The study sponsor is Otsuka Pharmaceutical Development & Commercialization, Inc., a pharmaceutical company.
Who was this study for?
This study was for people with type I bipolarity. Other eligibility criteria applied.
