Bipolar Disorder I
Conditions
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.
Interventions
DRUGAbilify 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.
Sponsors
Otsuka Pharmaceutical Co., Ltd.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
\-
Exclusion criteria
* patients with a known hypersensitivity to aripiprazole
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety Information (Adverse Event) | 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. |
| Number of Special Situations (e.g. Maternal (pregnancy and breastfeeding) exposure, paternal (via semen) exposure or Overdose/Incorrect dosage) | 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) |
| Number of off-Label Use | 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) |
| Incidence of Serious Adverse Event (e.g. resulting in death or life-threatening) | 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) |
| Incidence of Non-serious Adverse Events (i.e. all Adverse Events that do not meet the definition of a serious Adverse Event) | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Collecting the number of patients who recurrence/relapse of Mood Episodes (Efficacy Information) |
Countries
Japan
Outcome results
None listed