Bipolar Disorder INCT04812379
Specified Drug-use Survey on Abilify Prolonged Release Aqueous Suspension for IM Injection (Prevention of Relapse of Mood Episodes in BP)
An observational study of Bipolar Disorder I, run by Otsuka Pharmaceutical Co., Ltd. at 1 site in Japan.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Bipolar Disorder I
- What is being tested?
- Abilify prolonged release aqueous suspension for IM injection (Aripiprazole)
- Type of treatment
- Injection or infusion
- How many people
- 535 participants
- Where
- 1 siteJapan
- Study dates
- 7 Apr 2021to 21 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- -
Who cannot join
- patients with a known hypersensitivity to aripiprazole
Trial locations and contacts
1 site in 1 country.
About this study
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)
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
- Being tested
- Abilify prolonged release aqueous suspension for IM injection (Aripiprazole)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Collecting the number of patients who recurrence/relapse of Mood Episodes (Efficacy Information)
Measured: 52 weeks from the start date of Abilify prolonged release aqueous suspension for IM injection therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2021
- Study start7 Apr 2021
- Primary completion13 Sep 2023
- Study completion21 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar Disorder IStudies of the same condition, open and under way.
- More trials run by Otsuka Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 535 participants (actual)
Sponsor and investigators
- Lead sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yasuhiko Fukuta, PhD, Study director, Otsuka Pharmaceutical Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04812379
- Sponsor's protocol ID
- 031-101-00461
- Status last verified
- Mar 2025
- First submitted
- 16 Mar 2021
- Last updated
- 21 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04812379
- Acronym / sponsor ID
- 031-101-00461
- Conditions
- Bipolar Disorder I
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 535 participants (actual)
- Lead sponsor
- Otsuka Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 7 Apr 2021 (actual)
- Primary completion
- 13 Sep 2023 (actual)
- Study completion
- 21 Jun 2024 (actual)
- First posted
- 23 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- -
Key exclusion criteria (1 listed)
- patients with a known hypersensitivity to aripiprazole
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | – |
Primary outcome
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.
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)
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)
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)
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)
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2025.
Related trials for Bipolar Disorder I
Recruiting
Safety and Feasibility of DBS for Bipolar Depression
Bipolar I Disorder, Bipolar Depression
Not yet recruiting
Compulsive Eating and Brain's Reward System in Different Pathologies
PARKINSON DISEASE (Disorder), Bipolar 1 Disorder
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
RecruitingPhase 3
A Study to Evaluate the Efficacy and Safety of Adjunctive KarXT for the Treatment of Mania, With or Without Mixed Features, in Participants With Bipolar-I Disorder Taking Lithium, Valproate, or Lamotrigine
Mania, Bipolar Disorder
RecruitingPhase 3
Multicenter Study of Lumateperone for the Treatment of Bipolar Depression in Pediatric Patients
Bipolar Depression
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yasuhiko Fukuta, PhD study director
Otsuka Pharmaceutical Co., Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bipolar Disorder I, run by Otsuka Pharmaceutical Co., Ltd. at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety Information (Adverse Event) (time frame: 52 weeks from the start date of Abilify prolonged release aqueous suspension for IM injection therapy). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2025.