Study of Oral ABBV-932 to Assess Adverse Events and Change in Disease Activity in Adult Participants With Bipolar I or II Disorder (CANTO)

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

Bipolar disorder is a severe chronic mood disorder that affects up to 4% of the adult 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.

Study Overview

• Status: Completed
• Conditions: Bipolar I Disorder; Bipolar II Disorder
• Intervention / Treatment: Drug: ABBV-932; Drug: Placebo for ABBV-932

• Study Type: Interventional
• Enrollment (Actual): 161
• Phase: Phase 2

Contacts and Locations

Study Locations

• Japan
  • Fukuoka, Japan, 810-0022
    • Kaku Mental Clinic /ID# 268020
  • Fukuoka, Japan, 819-0037
    • Kuramitsu Hospital /ID# 268751
  • Fukuoka
    • Kitakyushu, Fukuoka, Japan, 802-0006
      • Kokura Mental Clinic /ID# 268031
  • Hokkaido
    • Sapporo, Hokkaido, Japan, 001-0023
      • Kawamura Mental Clinic /ID# 268325
  • Kanagawa
    • Sagamihara, Kanagawa, Japan, 252-0303
      • Yutaka Clinic /ID# 268026
• Puerto Rico
  • San Juan, Puerto Rico, 00918-3014
    • INSPIRA Clinical Research /ID# 267041
  • San Juan, Puerto Rico, 00918
    • Instituto De Neurologia Dra. Ivonne Fraga, Psc /ID# 267065
  • San Juan, Puerto Rico, 00927
    • BDH Research /ID# 267025
• United States
  • Alabama
    • Dothan, Alabama, United States, 36303
      • Harmonex /ID# 267504
  • California
    • Anaheim, California, United States, 92805
      • Advanced Research Center /ID# 267716
    • Colton, California, United States, 92324
      • Axiom Research /ID# 267518
    • Garden Grove, California, United States, 92845
      • Collaborative Neuroscience Research - Garden Grove /ID# 267654
    • Imperial, California, United States, 92251
      • Sun Valley Research Center /ID# 267708
    • Long Beach, California, United States, 90807
      • Alliance for Research Alliance for Wellness /ID# 267492
    • Oceanside, California, United States, 92056
      • Excell Research /ID# 267541
    • Temecula, California, United States, 92591
      • Viking Clinical Research Center - Temecula /ID# 267634
  • Florida
    • Largo, Florida, United States, 33777
      • Accel Research Sites Network - St. Pete /ID# 267463
    • Miami, Florida, United States, 33125
      • GMI Florida - Central Miami Medical Institute /ID# 267566
    • Miami, Florida, United States, 33155
      • Allied Biomedical Res Inst Inc /ID# 267481
    • Orlando, Florida, United States, 32751
      • K2 Medical Research - Orlando - South Orlando Avenue /ID# 267567
    • Tamarac, Florida, United States, 33319-4985
      • Segal Trials - West Broward Outpatient Research Site /ID# 267947
  • Louisiana
    • Shreveport, Louisiana, United States, 71101
      • Benchmark Research /ID# 267626
  • Maryland
    • Gaithersburg, Maryland, United States, 20877-1407
      • CenExel /ID# 267675
  • Missouri
    • St Louis, Missouri, United States, 63125
      • Arch Clinical Trials /ID# 267507
  • Nevada
    • Las Vegas, Nevada, United States, 89121
      • Duplicate_Oasis Clinical Research, LLC /ID# 267969
  • New Jersey
    • Cherry Hill, New Jersey, United States, 08002
      • Center For Emotional Fitness - Cherry Hill /ID# 267661
    • Toms River, New Jersey, United States, 08755
      • Bio Behavioral Health /ID# 267493
  • New York
    • Cedarhurst, New York, United States, 11516
      • Neurobehavioral Research /ID# 267564
  • North Carolina
    • Charlotte, North Carolina, United States, 28211
      • New Hope Clinical Research - Inpatient unit /ID# 267465
  • Ohio
    • Avon Lake, Ohio, United States, 44012
      • Quest Therapeutics of Avon Lake /ID# 267558
    • Columbus, Ohio, United States, 43210
      • OSU Psychiatry Department /ID# 267730
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73116
      • Sooner Clinical Research /ID# 267639
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18103
      • Lehigh Center for Clinical Research /ID# 267451
    • Media, Pennsylvania, United States, 19063
      • Suburban Research Associates - Media /ID# 267621
  • South Carolina
    • Charleston, South Carolina, United States, 29492
      • Coastal Carolina Research Center, LLC /ID# 267550
  • Texas
    • Dallas, Texas, United States, 75231
      • FutureSearch Trials of Dallas /ID# 267715
    • Richmond, Texas, United States, 77407
      • Perceptive Pharma Research /ID# 267563
    • Wichita Falls, Texas, United States, 76309
      • Grayline Research Center /ID# 267466
  • Washington
    • Bellevue, Washington, United States, 98007
      • Northwest Clinical Research Center /ID# 267505
    • Everett, Washington, United States, 98201
      • Core Clinical Research /ID# 268534

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.
• Have a minimum score of 20 on the 17-item Hamilton Depression Rating Scale (HAMD-17).
• Have a minimum score of 2 on Item 1 of the HAMD-17 at screening.

Exclusion Criteria:

• Positive urine drug screen (UDS) result at screening.
• Treated with any investigational drug within 4 weeks or 5 half-lives of the drug (whichever is longer) prior to the first dose of study drug, is currently enrolled in another clinical study, or was previously enrolled in this study.
• Current use of any antipsychotic, antidepressant, anticonvulsant, mood stabilizer, herb, or over-the-counter medication with psychoactive potential within 1 week or 5 half-lives of the medication (whichever is longer).
• Prior exposure to ABBV-932 within 90 days prior to baseline.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ABBV-932 Dose A; Participants will receive ABBV-932 Dose A.	Drug: ABBV-932; Oral Capsule
Experimental: ABBV-932 Dose B; Participants will receive ABBV-932 Dose B.	Drug: ABBV-932; Oral Capsule
Experimental: ABBV-932 Dose C; Participants will receive ABBV-932 Dose C.	Drug: ABBV-932; Oral Capsule
Placebo Comparator: Placebo for ABBV-932; Participants will receive placebo.	Drug: Placebo for ABBV-932; Oral Capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score	The MADRS is a 10-item, clinician-rated scale that evaluates the participant's depressive symptomatology. Each item is scored on a 7-point scale with a score of 0 reflecting no symptoms and a score of 6 reflecting symptoms of maximum severity.	Up to Week 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Clinical Global Impression-Severity - Bipolar Disorder (CGI-S-BP)	CGI-S-BP is a single-item clinician-reported measure of severity of bipolar disorder. Clinicians are asked to rate the severity of mania, depression, and overall bipolar illness. Response options range from 1 to 7: 1 = normal, not ill through 7 = very severely ill.	Up to Week 6
Change From Baseline in Functioning Assessment Short Test (FAST) Total Score	FAST is a clinician-reported outcome measure designed to assess the main functioning problems experienced by psychiatric participants, particularly bipolar participants. The FAST includes 24 items in 6 domains of functioning. Clinicians are asked to respond on a 4-point Likert scale ranging from 0 to 3 (0 = no difficulty and 3 = severe difficulty). Higher scores indicate greater difficulties in functioning.	Up to Week 6
Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score	HAM-A is a 14-item, clinician-reported measure used to quantify and categorize the participant's anxiety over the past week. Items are rated on a 5-point Likert rating scale of "absent" (0; if symptoms are absent, insignificant, or clearly due to causes other than anxiety) through "very severe" (4; if symptom is incapacitating). The HAM-A total score ranges from 0 to 56, with higher scores indicating greater anxiety severity.	Up to Week 6

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Director: ABBVIE INC., AbbVie

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2024
• Primary Completion (Actual): November 12, 2025
• Study Completion (Actual): December 10, 2025

Study Registration Dates

• First Submitted: September 18, 2024
• First Submitted That Met QC Criteria: September 18, 2024
• First Posted (Actual): September 20, 2024

Study Record Updates

• Last Update Posted (Estimated): January 12, 2026
• Last Update Submitted That Met QC Criteria: January 9, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Bipolar Disorder; Bipolar I Disorder; Bipolar II Disorder; ABBV-932
• Additional Relevant MeSH Terms: Bipolar and Related Disorders; Mental Disorders; Mood Disorders; Bipolar Disorder
• Other Study ID Numbers: M23-894

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
• IPD Sharing Time Frame: For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
• IPD Sharing Access Criteria: To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes