Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06605599
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-18
Brief Title:
Study of Oral ABBV-932 to Assess Adverse Events and Change in Disease Activity in Adult Participants With Bipolar I or II Disorder
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Multicenter Randomized Double-blind Placebo-controlled Parallel-group Fixed-dose Study to Evaluate the Efficacy Safety and Tolerability of ABBV-932 in Subjects With Depressive Episodes Associated With Bipolar I or II Disorder
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
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 This study will assess how safe and effective ABBV-932 is in treating participants with bipolar I or II disorder
ABBV-932 is an investigational drug being developed for the treatment of depressive episodes in adult participants with bipolar I or II disorder Study doctors put participants in 1 of 4 groups called treatment arms There is a 1 in 4 chance that a participant will be assigned to placebo Around 160 adult participants with bipolar I or II disorder will be enrolled in approximately 40 sites worldwide
Participants will receive oral capsules of ABBV-932 or matching placebo once daily for 6 weeks 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
ABBV-932 is an investigational drug being developed for the treatment of depressive episodes in adult participants with bipolar I or II disorder Study doctors put participants in 1 of 4 groups called treatment arms There is a 1 in 4 chance that a participant will be assigned to placebo Around 160 adult participants with bipolar I or II disorder will be enrolled in approximately 40 sites worldwide
Participants will receive oral capsules of ABBV-932 or matching placebo once daily for 6 weeks 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?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None