Bipolar I DisorderCReW BP-INCT06256367
Observational Study of Oral Cariprazine Capsules to Assess Change in Disease Activity in Adult Participants With Bipolar I Disorder
An observational study of Bipolar I Disorder, run by AbbVie at 19 sites in 2 countries.
Trial summary
Bipolar I disorder (BP-I) is a common, chronic, and disabling mental illness with significant morbidity and mortality defined by episodes of mania and depression (or symptoms of both at once, known as mixed features). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bipolar I Disorder
- How many people
- 120 participants
- Where
- 19 sitesin 2 countries
- Study dates
- 18 Apr 2024to 23 Jan 2026
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with a bipolar I disorder diagnosis experiencing a major depressive episode (with or without mixed features) requiring treatment and being prescribed cariprazine by their physician; irrespective of study participation.
Who may be able to join
- Have a physician-confirmed diagnosis of BP-I, with or without comorbidities.
- Prescribed cariprazine as part of routine clinical practice with the intention of treating as per the approved market label, respective country indications, and by the physician under usual and customary practice of physician prescription.
- Have a Montgomery-Åsberg Depression Rating Scale (MADRS) score >= 20 at baseline.
- Have a Functioning Assessment Short Test (FAST) score >= 21 at baseline.
- Naïve to cariprazine in the current major depressive episode.
Who cannot join
- Have a medical or psychiatric condition, or planned surgical procedure, which will interfere with study participation, as judged by the investigator.
- Have a known contraindication to cariprazine including any of the following:
- Hypersensitivity to cariprazine or any ingredient in the formulation
- For all sites, concomitant use of strong cytochrome P450 (CYP) 3A4 inhibitors and inducers
- For Canadian sites, as per country label, concomitant use of moderate CYP 3A4 inhibitors and inducers
- Current major depressive episode duration > 12 months.
Trial locations and contacts
19 sites in 2 countries.
19 sites in 2 countries
United States11 sites
Georgia Psychiatric Consultants & Advanced Discovery Research /ID# 259975
Atlanta, Georgia, 30318-3102
Quest Therapeutics of Avon /ID# 259838
Avon Lake, Ohio, 44012-1004
Bowman Medical Group /ID# 259989
Beverly Hills, California, 90212-1910
University of Alabama at Birmingham - Main /ID# 260000
Birmingham, Alabama, 35233
Montano Wellness LLC /ID# 259837
Cromwell, Connecticut, 06416
Ut Southwestern Medical Center /Parkland Health and Hospital System /Id# 260001
Dallas, Texas, 75235-7709
Betts Psychiatric, PC /ID# 259737
Eugene, Oregon, 97401-6008
North Star Medical Research LL /ID# 259730
Middleburg Heights, Ohio, 44130
Rivus Wellness And Research Institute /ID# 259966
Oklahoma City, Oklahoma, 73112
Omaha Insomnia and Psychiatric Services /ID# 259961
Omaha, Nebraska, 68144-2359
UC Davis /ID# 259723
Sacramento, California, 95817-2310
Canada8 sites
Chatham-Kent Clinical Trials /ID# 262414
Chatham, Ontario, N7L 1C1
Grand River Hospital /ID# 263962
Kitchener, Ontario, N2G 1G3
Sunny Johnson Medical Research Associates /ID# 267713
Mississauga, Ontario, L5M 4N4
Institut universitaire en santé mentale de Montréal /ID# 264665
Montreal, Quebec, H1N 3M5
Southlake Regional Health Centre /ID# 264212
Newmarket, Ontario, L3Y 2P9
Clinique Woodward /ID# 264050
Sherbrooke, Quebec, J1G 2N5
START Clinic for Mood and Anxiety Disorders /ID# 262416
Toronto, Ontario, M4W 2N4
Douglas Mental Health University Institute /ID# 262048
Verdun, Quebec, H4H 1R2
About this study
Official title: Cariprazine Real-world Use in Bipolar I Disorder: Effectiveness, Functioning, Quality of Life, and Tolerability
Bipolar I disorder (BP-I) is a common, chronic, and disabling mental illness with significant morbidity and mortality defined by episodes of mania and depression (or symptoms of both at once, known as mixed features). This prospective, observational study will examine effectiveness, functioning and quality of life outcomes in adult patients with BP-I experiencing a major depressive episode (with or without mixed features) requiring treatment and initiating treatment with cariprazine. It will examine outcomes of cariprazine treatment in a real-world setting in patients with BP-I commonly seen in clinical practices.
Cariprazine (Vraylar) is a medication indicated in the United States and Canada to treat adult patients experiencing manic, mixed or depressive episodes associated with BP-I. This study plans to enroll approximately 170 adult patients with BP-I from the United States and Canada. Cariprazine should be prescribed by the physician under the usual and customary practice of physician prescription. The decision to initiate treatment with cariprazine should be made prior to, and independently from, the patient's decision to participate in the study.
Participants will receive cariprazine as prescribed by their physician. Observational data will be collected during visits which should align to routine standard of care for a duration of up to 24 weeks.
- Conditions
- Bipolar I Disorder
- Keywords
- Bipolar I Disorder, Cariprazine, CReW BP-I
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cariprazine | Participants will receive cariprazine as prescribed by their physician in routine clinical practice. The decision to initiate cariprazine should be made prior to, and independently from, the decision to participate in this study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline on Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score
MADRS is a 10-item questionnaire that is rated by investigators to assess changes in depression symptoms over the past week. The individual items (apparent sadness, reported sadness, feelings of tension, reduced appetite, reduced sleep, lassitude, concentration difficulties, pessimistic thoughts, inability to feel emotions, and suicidal thoughts) are scored from 0 (no symptoms) to 6 (maximum severity) and summed for the total score (range 0 to 60). Higher scores indicate more severe depression.
Measured: Up to Week 12
Secondary outcomes (1)
Change From Baseline on Functioning Assessment Short Test (FAST) Total Score
The FAST is comprised of 24 items and assesses disability or impairment in 6 domains: autonomy, occupational functioning, financial issues, interpersonal relationships, cognitive functioning, and leisure time. FAST is administered by the investigator as an interview. Items are rated using a 4-point scale, from 0 (no difficulty) to 3 (severe difficulty) then summed for a total score. Higher scores indicate more severe impairment.
Measured: Up to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2024
- Study start18 Apr 2024
- Primary completion23 Jan 2026
- Study completion23 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar I DisorderStudies of the same condition, open and under way.
- More trials run by AbbVieThe 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
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06256367
- Sponsor's protocol ID
- P24-477
- Acronym
- CReW BP-I
- Status last verified
- Feb 2026
- First submitted
- 5 Feb 2024
- Last updated
- 24 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cariprazine Real-world Use in Bipolar I Disorder: Effectiveness, Functioning, Quality of Life, and Tolerability
- ClinicalTrials.gov ID
- NCT06256367
- Acronym / sponsor ID
- CReW BP-I / P24-477
- Conditions
- Bipolar I Disorder
- Keywords
- Bipolar I Disorder, Cariprazine, CReW BP-I
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 18 Apr 2024 (actual)
- Primary completion
- 23 Jan 2026 (actual)
- Study completion
- 23 Jan 2026 (actual)
- First posted
- 13 Feb 2024 (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.
Bipolar I disorder (BP-I) is a common, chronic, and disabling mental illness with significant morbidity and mortality defined by episodes of mania and depression (or symptoms of both at once, known as mixed features). This prospective, observational study will examine effectiveness, functioning and quality of life outcomes in adult patients with BP-I experiencing a major depressive episode (with or without mixed features) requiring treatment and initiating treatment with cariprazine. It will examine outcomes of cariprazine treatment in a real-world setting in patients with BP-I commonly seen in clinical practices.
Cariprazine (Vraylar) is a medication indicated in the United States and Canada to treat adult patients experiencing manic, mixed or depressive episodes associated with BP-I. This study plans to enroll approximately 170 adult patients with BP-I from the United States and Canada. Cariprazine should be prescribed by the physician under the usual and customary practice of physician prescription. The decision to initiate treatment with cariprazine should be made prior to, and independently from, the patient's decision to participate in the study.
Participants will receive cariprazine as prescribed by their physician. Observational data will be collected during visits which should align to routine standard of care for a duration of up to 24 weeks.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cariprazine | – | –Participants will receive cariprazine as prescribed by their physician in routine clinical practice. The decision to initiate cariprazine should be made prior to, and independently from, the decision to participate in this study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a bipolar I disorder diagnosis experiencing a major depressive episode (with or without mixed features) requiring treatment and being prescribed cariprazine by their physician; irrespective of study participation.
Key inclusion criteria (5 listed)
- Have a physician-confirmed diagnosis of BP-I, with or without comorbidities.
- Prescribed cariprazine as part of routine clinical practice with the intention of treating as per the approved market label, respective country indications, and by the physician under usual and customary practice of physician prescription.
- Have a Montgomery-Åsberg Depression Rating Scale (MADRS) score >= 20 at baseline.
- Have a Functioning Assessment Short Test (FAST) score >= 21 at baseline.
- Naïve to cariprazine in the current major depressive episode.
Key exclusion criteria (6 listed)
- Have a medical or psychiatric condition, or planned surgical procedure, which will interfere with study participation, as judged by the investigator.
- Have a known contraindication to cariprazine including any of the following:
- Current major depressive episode duration > 12 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change From Baseline on Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score
Time frame: Up to Week 12
MADRS is a 10-item questionnaire that is rated by investigators to assess changes in depression symptoms over the past week. The individual items (apparent sadness, reported sadness, feelings of tension, reduced appetite, reduced sleep, lassitude, concentration difficulties, pessimistic thoughts, inability to feel emotions, and suicidal thoughts) are scored from 0 (no symptoms) to 6 (maximum severity) and summed for the total score (range 0 to 60). Higher scores indicate more severe depression.
1 secondary outcome
Change From Baseline on Functioning Assessment Short Test (FAST) Total Score
Time frame: Up to Week 12
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 24 Feb 2026.
- Individual participant dataSharing planned: Undecided
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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.
ABBVIE INC. study director
AbbVie
19 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bipolar I Disorder, run by AbbVie at 19 sites in 2 countries.
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 5 inclusion and 6 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 24 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States, Canada. 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?
Change From Baseline on Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score (time frame: Up to Week 12). 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 24 Feb 2026.