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Bipolar I DisorderPhase 2CANTONCT06605599

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

A Phase 2 study testing ABBV-932 in people with Bipolar I Disorder and Bipolar II Disorder, run by AbbVie at 40 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Bipolar I Disorder, Bipolar II Disorder
What is being tested?
ABBV-932
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
161 participants
Where
40 sitesin 3 countries
Study dates
15 Oct 2024to 10 Dec 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

40 sites in 3 countries.

40 sites in 3 countries

United States32 sites

  • Lehigh Center for Clinical Research /ID# 267451

    Allentown, Pennsylvania, 18103

  • Advanced Research Center /ID# 267716

    Anaheim, California, 92805

  • Quest Therapeutics of Avon Lake /ID# 267558

    Avon Lake, Ohio, 44012

  • Northwest Clinical Research Center /ID# 267505

    Bellevue, Washington, 98007

  • Neurobehavioral Research /ID# 267564

    Cedarhurst, New York, 11516

  • Coastal Carolina Research Center, LLC /ID# 267550

    Charleston, South Carolina, 29492

  • New Hope Clinical Research - Inpatient unit /ID# 267465

    Charlotte, North Carolina, 28211

  • Center For Emotional Fitness - Cherry Hill /ID# 267661

    Cherry Hill, New Jersey, 08002

  • Axiom Research /ID# 267518

    Colton, California, 92324

  • OSU Psychiatry Department /ID# 267730

    Columbus, Ohio, 43210

  • FutureSearch Trials of Dallas /ID# 267715

    Dallas, Texas, 75231

  • Harmonex /ID# 267504

    Dothan, Alabama, 36303

  • Core Clinical Research /ID# 268534

    Everett, Washington, 98201

  • CenExel /ID# 267675

    Gaithersburg, Maryland, 20877-1407

  • Collaborative Neuroscience Research - Garden Grove /ID# 267654

    Garden Grove, California, 92845

  • Sun Valley Research Center /ID# 267708

    Imperial, California, 92251

  • Accel Research Sites Network - St. Pete /ID# 267463

    Largo, Florida, 33777

  • Duplicate_Oasis Clinical Research, LLC /ID# 267969

    Las Vegas, Nevada, 89121

  • Alliance for Research Alliance for Wellness /ID# 267492

    Long Beach, California, 90807

  • Suburban Research Associates - Media /ID# 267621

    Media, Pennsylvania, 19063

  • GMI Florida - Central Miami Medical Institute /ID# 267566

    Miami, Florida, 33125

  • Allied Biomedical Res Inst Inc /ID# 267481

    Miami, Florida, 33155

  • Excell Research /ID# 267541

    Oceanside, California, 92056

  • Sooner Clinical Research /ID# 267639

    Oklahoma City, Oklahoma, 73116

  • K2 Medical Research - Orlando - South Orlando Avenue /ID# 267567

    Orlando, Florida, 32751

  • Perceptive Pharma Research /ID# 267563

    Richmond, Texas, 77407

  • Benchmark Research /ID# 267626

    Shreveport, Louisiana, 71101

  • Arch Clinical Trials /ID# 267507

    St Louis, Missouri, 63125

  • Segal Trials - West Broward Outpatient Research Site /ID# 267947

    Tamarac, Florida, 33319-4985

  • Viking Clinical Research Center - Temecula /ID# 267634

    Temecula, California, 92591

  • Bio Behavioral Health /ID# 267493

    Toms River, New Jersey, 08755

  • Grayline Research Center /ID# 267466

    Wichita Falls, Texas, 76309

Other trials in United States

Japan5 sites

  • Kaku Mental Clinic /ID# 268020

    Fukuoka, Fukuoka, 810-0022

  • Kuramitsu Hospital /ID# 268751

    Fukuoka, Fukuoka, 819-0037

  • Kokura Mental Clinic /ID# 268031

    Kitakyushu, Fukuoka, 802-0006

  • Yutaka Clinic /ID# 268026

    Sagamihara, Kanagawa, 252-0303

  • Kawamura Mental Clinic /ID# 268325

    Sapporo, Hokkaido, 001-0023

Other trials in Japan

Puerto Rico3 sites

  • INSPIRA Clinical Research /ID# 267041

    San Juan, Puerto Rico, 00918-3014

  • Instituto De Neurologia Dra. Ivonne Fraga, Psc /ID# 267065

    San Juan, Puerto Rico, 00918

  • BDH Research /ID# 267025

    San Juan, Puerto Rico, 00927

Other trials in Puerto Rico

About this study

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

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.

Read more

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.

Being tested
ABBV-932, Placebo for ABBV-932
Keywords
Bipolar I Disorder, Bipolar II Disorder, Bipolar Disorder, ABBV-932
Medical subject headings
Bipolar Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ABBV-932Drug

    Oral Capsule

  • Placebo for ABBV-932Drug

    Oral Capsule

Study groups in NCT06605599
Study groupRoleWhat they receive
ABBV-932 Dose AExperimentalParticipants will receive ABBV-932 Dose A.
Receives: Drug: ABBV-932
ABBV-932 Dose BExperimentalParticipants will receive ABBV-932 Dose B.
Receives: Drug: ABBV-932
ABBV-932 Dose CExperimentalParticipants will receive ABBV-932 Dose C.
Receives: Drug: ABBV-932
Placebo for ABBV-932Placebo comparatorParticipants will receive placebo.
Receives: Drug: Placebo for ABBV-932

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to Week 6

Secondary outcomes (3)

  1. 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.

    Measured: Up to Week 6

  2. 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.

    Measured: Up to Week 6

  3. 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.

    Measured: Up to Week 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Sep 2024
  2. Study start15 Oct 2024
  3. Primary completion12 Nov 2025
  4. Study completion10 Dec 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
161 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06605599
Sponsor's protocol ID
M23-894
Acronym
CANTO
Status last verified
Jan 2026
First submitted
18 Sep 2024
Last updated
14 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ABBV-932 in people with Bipolar I Disorder and Bipolar II Disorder, run by AbbVie at 40 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 40 sites in United States, Japan, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score (time frame: Up to Week 6). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06605599.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026.

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