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ABBV-932 for Bipolar Disorder (CANTO - (BP-D) Trial)
Phase 2
Recruiting
Research Sponsored by AbbVie
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
* Meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) criteria for bipolar I or II disorder without psychotic features based on the Mini International Neuropsychiatric Interview (MINI), with a current depressive episode of at least 4 weeks and not exceeding 12 months.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to week 6
Summary
This trial will test a new drug, ABBV-932, to see if it is safe and effective in treating people with bipolar disorder. Around 160 adults with bipolar I or II disorder will
Who is the study for?
Adults with bipolar I or II disorder, currently experiencing a depressive episode lasting between 4 weeks and 12 months. Participants must score at least 20 on the HAMD-17 depression scale and no more than 12 on the YMRS mania scale.
What is being tested?
The trial is testing ABBV-932, a new oral medication for treating depressive episodes in adults with bipolar disorder. Patients are randomly assigned to one of four groups, including a placebo group. The treatment lasts for six weeks followed by four weeks of safety follow-up.
What are the potential side effects?
Specific side effects of ABBV-932 aren't listed but may include typical drug reactions such as nausea, headache, dizziness, or other symptoms that will be monitored through medical assessments and blood tests.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with bipolar disorder without psychosis, currently in a depressive phase lasting 4-12 weeks.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to week 6
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to week 6
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score
Secondary study objectives
Change From Baseline in Clinical Global Impression-Severity - Bipolar Disorder (CGI-S-BP)
Change From Baseline in Functioning Assessment Short Test (FAST) Total Score
Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score
Trial Design
4Treatment groups
Experimental Treatment
Placebo Group
Group I: ABBV-932 Dose CExperimental Treatment1 Intervention
Participants will receive ABBV-932 Dose C.
Group II: ABBV-932 Dose BExperimental Treatment1 Intervention
Participants will receive ABBV-932 Dose B.
Group III: ABBV-932 Dose AExperimental Treatment1 Intervention
Participants will receive ABBV-932 Dose A.
Group IV: Placebo for ABBV-932Placebo Group1 Intervention
Participants will receive placebo.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ABBV-932
2023
Completed Phase 1
~110
Find a Location
Who is running the clinical trial?
AbbVieLead Sponsor
1,040 Previous Clinical Trials
523,419 Total Patients Enrolled
3 Trials studying Bipolar Disorder
619 Patients Enrolled for Bipolar Disorder
ABBVIE INC.Study DirectorAbbVie
461 Previous Clinical Trials
164,204 Total Patients Enrolled
3 Trials studying Bipolar Disorder
619 Patients Enrolled for Bipolar Disorder