Ignite Creation Date:
2025-12-25 @ 12:54 AM
Ignite Modification Date:
2026-01-01 @ 3:24 AM
Study NCT ID:
NCT06256367
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-09-23
First Post:
2024-02-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Observational Study of Oral Cariprazine Capsules to Assess Change in Disease Activity in Adult Participants With Bipolar I Disorder
Sponsor:
AbbVie
Organization:
Study Overview
Official Title:
Cariprazine Real-world Use in Bipolar I Disorder: Effectiveness, Functioning, Quality of Life, and Tolerability
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CReW BP-I
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: