Clinical trial NCT06256367: Observational Study of Oral Cariprazine Capsules to Assess Change in Disease Activity in Adult Participants With Bipolar I Disorder
Official title: Cariprazine Real-world Use in Bipolar I Disorder: Effectiveness, Functioning, Quality of Life, and Tolerability
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Bipolar I Disorder
Keywords: Bipolar I Disorder
Cariprazine
CReW BP-I
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2024-02-13
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

Brief 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). 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change From Baseline on Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score
timeFrame: Up to Week 12
Secondary outcomes:
measure: Change From Baseline on Functioning Assessment Short Test (FAST) Total Score
timeFrame: Up to Week 12
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham - Main /ID# 260000
state: Alabama
city: Beverly Hills
country: United States
facility: Bowman Medical Group /ID# 259989
state: California
city: Sacramento
country: United States
facility: UC Davis /ID# 259723
state: California
city: Cromwell
country: United States
facility: Montano Wellness LLC /ID# 259837
state: Connecticut
city: Atlanta
country: United States
facility: Georgia Psychiatric Consultants & Advanced Discovery Research /ID# 259975
state: Georgia
city: Omaha
country: United States
facility: Omaha Insomnia and Psychiatric Services /ID# 259961
state: Nebraska
city: Avon Lake
country: United States
facility: Quest Therapeutics of Avon /ID# 259838
state: Ohio
city: Middleburg Heights
country: United States
facility: North Star Medical Research LL /ID# 259730
state: Ohio
city: Oklahoma City
country: United States
facility: Rivus Wellness And Research Institute /ID# 259966
state: Oklahoma
city: Eugene
country: United States
facility: Betts Psychiatric, PC /ID# 259737
state: Oregon
city: Dallas
country: United States
facility: Ut Southwestern Medical Center /Parkland Health and Hospital System /Id# 260001
state: Texas
city: Chatham
country: Canada
facility: Chatham-Kent Clinical Trials /ID# 262414
state: Ontario
city: Kitchener
country: Canada
facility: Grand River Hospital /ID# 263962
state: Ontario
city: Mississauga
country: Canada
facility: Sunny Johnson Medical Research Associates /ID# 267713
state: Ontario
city: Newmarket
country: Canada
facility: Southlake Regional Health Centre /ID# 264212
state: Ontario
city: Toronto
country: Canada
facility: START Clinic for Mood and Anxiety Disorders /ID# 262416
state: Ontario
city: Montreal
country: Canada
facility: Institut universitaire en santé mentale de Montréal /ID# 264665
state: Quebec
city: Sherbrooke
country: Canada
facility: Clinique Woodward /ID# 264050
state: Quebec
city: Verdun
country: Canada
facility: Douglas Mental Health University Institute /ID# 262048
state: Quebec
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: