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

NCT04812379 | Completed FDA Drug

• 1 other identifier: 031-101-00461
• Study Type: observational
• Target: 535
• Locations: 1 country
• Sites: 1

Brief 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

Bipolar Disorder I

Outcome Measures

Primary Outcomes (5)

• Safety Information (Adverse Event)

  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)

  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

  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)

  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)

  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 Outcomes (1)

• Number of patients who recurrence/relapse of Mood Episodes

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

Interventions

Abilify prolonged release aqueous suspension for IM injection (Aripiprazole) DRUG

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may not qualify if:

• patients with a known hypersensitivity to aripiprazole

Sponsors & Collaborators

• Otsuka Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Pharmacovigilance Department

Osaka, Osaka, 540-0021, Japan

Location

MeSH Terms

Interventions

Injections, Intramuscular; Aripiprazole

Intervention Hierarchy (Ancestors)

Injections; Drug Administration Routes; Drug Therapy; Therapeutics; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Yasuhiko Fukuta, PhD

  Otsuka Pharmaceutical Co., Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2021
• First Posted: March 23, 2021
• Study Start: April 7, 2021
• Primary Completion: September 13, 2023
• Study Completion: June 21, 2024
• Last Updated: March 21, 2025

Record last verified: 2025-03

Locations

JP (1)