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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.
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

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Pharmacovigilance Department
Coordinator of this site? Confirm its status
OsakaJapanUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.