Ignite Creation Date:
2024-05-06 @ 3:50 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04777357
Status:
RECRUITING
Last Update Posted:
2024-06-20
First Post:
2021-02-26
Brief Title:
A Study to Assess Change in Disease Activity and Adverse Events AEs With Cariprazine in the Treatment of Depressive Episodes in Pediatric Participants Participants 10 to 17 Years of Age With Bipolar I Disorder
Sponsor:
AbbVie
Organization:
AbbVie
Study Overview
Official Title:
A 6-week Multicenter Randomized Double-blind Parallel-group Placebo-controlled Study of the Efficacy and Safety of Cariprazine in Pediatric Subjects 10 to 17 Years of Age in the Treatment of Depressive Episodes Associated With Bipolar I Disorder
Status:
RECRUITING
Status Verified Date:
2024-10
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:
None
Brief Summary:
Bipolar disorder is a severe chronic mood disorder that affects up to 4 of the adult population and 18 of the pediatric population in the United States The treatment of the depressive episodes of bipolar disorder in the pediatric population has not been as widely studied as the treatment of depressive episodes in bipolar disorder in adults therefore pharmacotherapeutic options are limited Given the change in disease state and safety demonstrated in adults with depressive episodes associated with bipolar I disorder the purpose of this study is to evaluate the change in disease state and safety of cariprazine in the treatment of depressive episodes associated with bipolar I disorder in the pediatric population
Cariprazine is an approved drug for the treatment of depressive episodes in adult participants with bipolar I disorder Study doctors put participants in 1 of 2 groups called treatment arms There is a 1 in 2 chance that a participant will be assigned to placebo Around 380 Participants ages 10-17 years with bipolar I disorder will be enrolled in approximately 60 sites worldwide
Participants receiving the study drug will receive Dose A or B of Cariprazine based on age and weight At Week 3 participants with insufficient response will have their dose increased to Dose B or Dose C while participants with sufficient response will continue receiving the Dose A or B for the remainder of the treatment period The treatment period will be followed by a safety follow-up SFU period for 4 weeks
There may be higher treatment burden for participants in this trial compared to their standard of care Participants will attend regular weekly visits during the study at a hospital or clinic The effect of the treatment will be checked by medical assessments blood tests checking for side effects and completing questionnaires
Cariprazine is an approved drug for the treatment of depressive episodes in adult participants with bipolar I disorder Study doctors put participants in 1 of 2 groups called treatment arms There is a 1 in 2 chance that a participant will be assigned to placebo Around 380 Participants ages 10-17 years with bipolar I disorder will be enrolled in approximately 60 sites worldwide
Participants receiving the study drug will receive Dose A or B of Cariprazine based on age and weight At Week 3 participants with insufficient response will have their dose increased to Dose B or Dose C while participants with sufficient response will continue receiving the Dose A or B for the remainder of the treatment period The treatment period will be followed by a safety follow-up SFU period for 4 weeks
There may be higher treatment burden for participants in this trial compared to their standard of care Participants will attend regular weekly visits during the study at a hospital or clinic The effect of the treatment will be checked by medical assessments blood tests checking for side effects and completing questionnaires
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2020-004758-32 | EUDRACT_NUMBER | None | None |