NCT04812379Completed
Specified Drug-use Survey on Abilify Prolonged Release Aqueous Suspension for IM Injection (Prevention of Relapse of Mood Episodes in BP)
Abilify Prolonged Release Aqueous Suspension for Intramuscular Injection Specified Drug-use Results Survey (Prevention of Recurrence/relapse of Mood Episodes in Bipolar I Disorder)
Source: ClinicalTrials.gov · Last updated 21 Mar 2025
Brief summary (registry, in English)
To investigate the safety for an observation period of 52 weeks with use of Abilify prolonged release aqueous suspension for intramuscular (IM) injection in patients with bipolar I disorder for prevention of recurrence/relapse of mood episodes in the routine clinical setting. The early stage safety after the switching from oral aripiprazole to this IM injection is investigated including extrapyramidal syndrome and malignant syndrome. Information regarding efficacy is collected as well.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 535 (actual)
- First submitted
- 16 Mar 2021
- Start date
- 7 Apr 2021
- Primary completion date
- 13 Sept 2023
- Lead sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Diseases
- Bipolar disorder
- NCT number
- NCT04812379
What you commit to
- Study type: Observational
- Participants enrolled: 535
- From 7 Apr 2021 to the primary completion date, 13 Sept 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- patients with a known hypersensitivity to aripiprazole
Who the study is looking for
- \-
Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Pharmacovigilance Department Coordinator of this site? Confirm its status | Osaka | Japan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.