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Specified Drug-use Survey on Abilify Prolonged Release Aqueous Suspension for IM Injection (Prevention of Relapse of Mood Episodes in BP)

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Otsuka

Status

Completed

Conditions

Bipolar Disorder I

Treatments

Drug: Abilify prolonged release aqueous suspension for IM injection (Aripiprazole)

Study type

Observational

Funder types

Industry

Identifiers

NCT04812379
031-101-00461

Details and patient eligibility

About

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.

Enrollment

535 patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria

Exclusion criteria

  • patients with a known hypersensitivity to aripiprazole

Trial contacts and locations

1

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Central trial contact

Pharmacovigilance Department Otsuka Pharmaceutical Co., Ltd

Data sourced from clinicaltrials.gov

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