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.
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
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
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
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
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.
- Conditions
- Bipolar I Disorder, Bipolar II Disorder
- 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 group | Role | What they receive |
|---|---|---|
| ABBV-932 Dose A | Experimental | Participants will receive ABBV-932 Dose A. Receives: Drug: ABBV-932 |
| ABBV-932 Dose B | Experimental | Participants will receive ABBV-932 Dose B. Receives: Drug: ABBV-932 |
| ABBV-932 Dose C | Experimental | Participants will receive ABBV-932 Dose C. Receives: Drug: ABBV-932 |
| Placebo for ABBV-932 | Placebo comparator | Participants 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.
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)
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
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
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.
- First posted20 Sep 2024
- Study start15 Oct 2024
- Primary completion12 Nov 2025
- Study completion10 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar I DisorderStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
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.