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

Bipolar Disorder I Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04812379
• Other study ID #: 031-101-00461
• Status: Active, not recruiting
• Start date: April 7, 2021
• Est. completion date: September 2024

Study information

• Verified date: November 2023
• Source: Otsuka Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 535
• Est. completion date: September 2024
• Est. primary completion date: September 13, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

-

Exclusion Criteria:

• patients with a known hypersensitivity to aripiprazole

Related Conditions & MeSH terms

• Bipolar Disorder
• Bipolar Disorder I

Intervention

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.

Locations

Country	Name	City	State
Japan	Pharmacovigilance Department	Osaka

Sponsors (1)

Lead Sponsor	Collaborator
Otsuka Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Number of patients who recurrence/relapse of Mood Episodes	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