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

November 1, 2023 updated by: Otsuka Pharmaceutical Co., Ltd.

Abilify Prolonged Release Aqueous Suspension for Intramuscular Injection Specified Drug-use Results Survey (Prevention of Recurrence/Relapse of Mood Episodes in Bipolar I Disorder)

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

535

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Osaka, Japan, 540-0021
        • Pharmacovigilance Department

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients in Japan with bipolar I disorder who are planned to be newly started on Abilify prolonged release aqueous suspension for IM injection, switching from oral aripiprazole for the purpose of prevention of recurrence/relapse of mood episodes

Description

Inclusion Criteria:

-

Exclusion Criteria:

  • patients with a known hypersensitivity to aripiprazole

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety Information (Adverse Event)
Time Frame: 52 weeks from the start date of Abilify prolonged release aqueous suspension for IM injection therapy

Any untoward medicinal occurrence in a patient or clinical study subject administered a Medicinal Product and which does not necessarily have a causal relationship with this treatment (ICH-E2A Guideline).

An Adverse Event can therefore be any unfavorable and unintended sign (e.g. abnormal laboratory finding), symptom, or disease temporally associated with the use of a Medicinal Product (Abilify Prolonged Release Aqueous Suspension), whether or not it is considered causally related to the Medicinal Product.
52 weeks from the start date of Abilify prolonged release aqueous suspension for IM injection therapy
Number of Special Situations (e.g. Maternal (pregnancy and breastfeeding) exposure, paternal (via semen) exposure or Overdose/Incorrect dosage)
Time Frame: 52 weeks from the start date of Abilify prolonged release aqueous suspension for IM injection therapy

Collecting any Situations related to the use of an Otsuka product which may or may not be associated with an adverse event:

  • Maternal (pregnancy and breastfeeding) or paternal (via semen) exposure;
  • Exposure during breastfeeding;
  • Overdose/Incorrect dosage, misuse, abuse (e.g. patient sharing products);
  • Medication errors (e.g. patient took wrong dose);
  • Lack of therapeutic efficacy (e.g. the product doesn't work);
  • Occupational exposure (e.g.: nurse administering the product is exposed);
  • Cases of suspected transmission of infectious agents;
  • Use of suspected or confirmed falsified product(s) or quality defect of the product(s);
  • Withdrawal reactions;
  • Accidental exposure (e.g.: child takes parent's product);
  • Drug-drug/drug-food interactions;
  • Unintentional use of product in a non-approved population (e.g.: pediatric or geriatric population);
  • Disease progression/exacerbation of existing disease

(Safety Information)
52 weeks from the start date of Abilify prolonged release aqueous suspension for IM injection therapy
Number of off-Label Use
Time Frame: 52 weeks from the start date of Abilify prolonged release aqueous suspension for IM injection therapy

Collecting any type of off-Label Use that refers to situations where a product is intentionally used for a medical purpose not in accordance with the authorized product information. Off-label use also includes the intentional use in non-authorized population categories not indicated in the label.

(Safety Information)
52 weeks from the start date of Abilify prolonged release aqueous suspension for IM injection therapy
Incidence of Serious Adverse Event (e.g. resulting in death or life-threatening)
Time Frame: 52 weeks from the start date of Abilify prolonged release aqueous suspension for IM injection therapy

Collecting the number of any adverse drug experience/event occurring at any dose which

  • results in death
  • is life-threatening
  • requires inpatient hospitalization or prolonged of existing hospitalization
  • results in persistent or significant disability or incapacity
  • is a congenital anomaly/birth defect
  • is medically significant.

(Safety Information)
52 weeks from the start date of Abilify prolonged release aqueous suspension for IM injection therapy
Incidence of Non-serious Adverse Events (i.e. all Adverse Events that do not meet the definition of a serious Adverse Event)
Time Frame: 52 weeks from the start date of Abilify prolonged release aqueous suspension for IM injection therapy

Collecting the number of non-serious Adverse Events

(Safety Information)
52 weeks from the start date of Abilify prolonged release aqueous suspension for IM injection therapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients who recurrence/relapse of Mood Episodes
Time Frame: 52 weeks from the start date of Abilify prolonged release aqueous suspension for IM injection therapy
Collecting the number of patients who recurrence/relapse of Mood Episodes (Efficacy Information)
52 weeks from the start date of Abilify prolonged release aqueous suspension for IM injection therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Otsuka Pharmaceutical Co., Ltd.

Investigators

  • Study Director: Yasuhiko Fukuta, PhD, Otsuka Pharmaceutical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 7, 2021

Primary Completion (Actual)

September 13, 2023

Study Completion (Estimated)

September 1, 2024

Study Registration Dates

First Submitted

March 16, 2021

First Submitted That Met QC Criteria

March 19, 2021

First Posted (Actual)

March 23, 2021

Study Record Updates

Last Update Posted (Actual)

November 2, 2023

Last Update Submitted That Met QC Criteria

November 1, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 031-101-00461

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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