Trials / Completed
CompletedNCT04812379
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)
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 535 (actual)
- Sponsor
- Otsuka Pharmaceutical Co., Ltd. · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Abilify prolonged release aqueous suspension for IM injection (Aripiprazole) | The usual dose in adults is 400 mg of aripiprazole administered intramuscularly in the gluteal or deltoid muscle as a single dose once every 4 weeks. The dose may be decreased to 300 mg based on the patient's symptoms and tolerability. |
Timeline
- Start date
- 2021-04-07
- Primary completion
- 2023-09-13
- Completion
- 2024-06-21
- First posted
- 2021-03-23
- Last updated
- 2025-03-21
Locations
1 site across 1 country: Japan
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04812379. Inclusion in this directory is not an endorsement.