Bipolar I or II DisorderPhase 2NCT07220460
Study to Assess the Adverse Events of Oral ABBV-932 in Adult Participants With Depressive Episodes Associated With Bipolar I or II Disorder
A Phase 2 study testing ABBV-932 in people with Bipolar I or II Disorder, run by AbbVie at 49 sites in 2 countries.
Trial summary
Bipolar disorder is a severe chronic mood disorder that affects up to 4% of the adult population in the United States. The purpose of this study is to assess how safe and effective ABBV-932 is in treating participants with depressive episodes associated 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 or II Disorder
- What is being tested?
- ABBV-932
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 49 sitesin 2 countries
- Study dates
- 30 Sep 2025to Apr 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Body Mass Index (BMI) >= 18.0 to <= 40.0 kg/m^2, inclusive.
- Participants who currently meet the Diagnostic and Statistical Manual of Mental Disorders treatment (DSM-5-TR) criteria for bipolar I or II disorder without psychotic features based on the Mini International Neuropsychiatric Interview (MINI 7.0.2), currently experiencing a depressive episode of at least 4 weeks and not exceeding 12 months.
- Normal physical examination findings, clinical laboratory test results, vital signs, and 12-lead ECG results at screening or abnormal results that are judged not clinically significant by the investigator and documented as such in the eCRF
- Participant with the following psychiatric history:
- No history of psychiatric hospitalization (inpatient or intensive outpatient) in the past 3 months prior to screening.
- No lifetime history of schizophrenia, other psychotic disorders, dissociative disorders, or neurocognitive disorders.
- No history of moderate or severe substance use disorder (except nicotine) in the past 6 months prior to screening.
- History of stable psychiatric comorbidities (e.g., PTSD, OCD) may be included provided these conditions have not required intervention with a prohibited medication within the past 12 months prior to Screening.
Who cannot join
- A total score greater than 12 on the Young Mania Rating Scale (YMRS) at baseline.
- History of an allergic reaction or significant sensitivity to constituents of the study drug (and its excipients) and/or other products in the same class.
- A concurrent medical condition that might interfere with the conduct of the study, confound the interpretation of the study results, or endanger the subject's well-being. This includes any unstable condition, history or evidence of malignancy (other than treated basal or squamous cell carcinoma), or any significant hematologic, endocrine, cardiovascular, respiratory, renal impairment or disease (e.g., participants with eGFR < 30 mL/min), hepatic (including history of severe hepatic impairment), gastrointestinal, or neurological disorder. If there is a history of such disease (except malignancy), but the condition has been stable for more than 1 year, does not require treatment with prohibited medications, and is judged by the investigator not to interfere with participation in the study, the subject may be included.
Trial locations and contacts
49 sites in 2 countries.
49 sites in 2 countries
United States47 sites
Lehigh Center for Clinical Research /ID# 273466
Allentown, Pennsylvania, 18103
Advanced Research Center /ID# 273474
Anaheim, California, 92805
Trialmed /ID# 278046
Atlanta, Georgia, 30328
Atlanta Center for Medical Research /ID# 278827
Atlanta, Georgia, 30331
Quest Therapeutics of Avon Lake /ID# 273484
Avon Lake, Ohio, 44012
Pharmasite Research, Inc. /ID# 279163
Baltimore, Maryland, 21208
Northwest Clinical Research Center /ID# 273480
Bellevue, Washington, 98007
Integrative Clinical Trials /ID# 278040
Brooklyn, New York, 11229
Neurobehavioral Research /ID# 273470
Cedarhurst, New York, 11516
New Hope Clinical Research /ID# 273468
Charlotte, North Carolina, 28211
Axiom Research /ID# 273482
Colton, California, 92324
OSU Psychiatry Department /ID# 273495
Columbus, Ohio, 43210
Connecticut Clinical Research - Cromwell /ID# 278116
Cromwell, Connecticut, 06416
Future Search Trials of Dallas /ID# 273473
Dallas, Texas, 75231
Epic Medical Research - DeSoto /ID# 278045
DeSoto, Texas, 75115
Revive Research Institute - Elgin /ID# 279756
Elgin, Illinois, 60123
Core Clinical Research /ID# 273498
Everett, Washington, 98201
Collaborative Neuroscience Research - Garden Grove /ID# 273492
Garden Grove, California, 92845
Sun Valley Research Center /ID# 273472
Imperial, California, 92251
MSB Neuroscience /ID# 278168
Jackson, Mississippi, 39216-4643
Clinical Neuroscience Solutions Healthcare - Jacksonville /ID# 278332
Jacksonville, Florida, 32256
Ima Clinical Research Las Vegas /ID# 278054
Las Vegas, Nevada, 89102
Redbird Research /ID# 279475
Las Vegas, Nevada, 89119
Segal Trials - Lauderhill /ID# 273496
Lauderhill, Florida, 33319
Synergy San Diego /ID# 278340
Lemon Grove, California, 91945
Alivation Research - Lincoln /ID# 279464
Lincoln, Nebraska, 68526
Alliance for Research Alliance for Wellness /ID# 273477
Long Beach, California, 90807
Nrc Research Institute - Los Angeles /ID# 278450
Los Angeles, California, 90015
K2 Medical Research -Maitland /ID# 273487
Maitland, Florida, 32751
GMI Florida - Central Miami Medical Institute (SMO/Network/Consortium) /ID# 273486
Miami, Florida, 33125
Allied Biomedical Res Inst Inc /ID# 273476
Miami, Florida, 33155
Floridian Clinical Research - Miami Lakes /ID# 279379
Miami Lakes, Florida, 33016
Ima Clinical Research - Manhattan /ID# 278941
New York, New York, 10036
Excell Research /ID# 273483
Oceanside, California, 92056
Sooner Clinical Research /ID# 273491
Oklahoma City, Oklahoma, 73116
Apg Research /ID# 278439
Orlando, Florida, 32803
Ima Clinical Research Phoenix /ID# 278047
Phoenix, Arizona, 85012
Summit Research Network - Portland - Northwest Vaughn Street /ID# 278084
Portland, Oregon, 97210
Perceptive Pharma Research /ID# 273485
Richmond, Texas, 77407
Benchmark Research /ID# 273490
Shreveport, Louisiana, 71101
Voltaire - Springfield /ID# 278446
Springfield, Massachusetts, 01103
Arch Clinical Trials /ID# 273481
St Louis, Missouri, 63125
Inland Psychiatric Medical Group /ID# 273471
Temecula, California, 92591
Family Psychiatry Of The Woodlands /ID# 278050
The Woodlands, Texas, 77381
Bio Behavioral Health /ID# 273478
Toms River, New Jersey, 08755
Sunwise Clinical Research /ID# 278165
Walnut Creek, California, 94596
Health Synergy Clinical Research - West Palm Beach /ID# 279384
West Palm Beach, Florida, 33407
Puerto Rico2 sites
Inspira Clinical Research /ID# 274670
San Juan, 00918-3014
BDH Research /ID# 274677
San Juan, 00927
About this study
Official title: Multicenter, Open-label Study to Evaluate the Long-term 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. The purpose of this study is to assess how safe and effective ABBV-932 is in treating participants with depressive episodes associated 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. Participants with bipolar I or II disorder who are currently experiencing a depressive episode will enter the study and be treated with open-label ABBV-932. Approximately 200 adult participants with bipolar I or II disorder will be enrolled in approximately 50 sites in the United States and Puerto Rico.
Read more
Participants will receive oral capsules of ABBV-932 for a 26-week treatment period. The treatment period will be followed by a safety follow-up (SFU) period of 30 days.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regularly scheduled 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 or II Disorder
- Being tested
- ABBV-932
- Keywords
- Bipolar I or II Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABBV-932Drug
Oral Capsule
| Study group | Role | What they receive |
|---|---|---|
| ABBV-932 | Experimental | Participants will receive oral ABBV-932 for a 26-week treatment period followed by a 30-day follow-up Receives: Drug: ABBV-932 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Experiencing Adverse Events
An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
Measured: Up to approximately 29 weeks
Number of Participants with Abnormal Change From Baseline in Vital Sign Measurements
Number of participants with abnormal change from baseline in vital sign measurements like systolic and diastolic blood pressure will be assessed.
Measured: Up to week 26
Number of Participants with Change from Baseline in Electrocardiogram (ECG)
12-lead resting ECG will be recorded.
Measured: Up to week 26
Number of Participants with Abnormal Change in Clinical Laboratory Test Results Like Hematology will be Assessed
Number of participants with abnormal change in clinical laboratory test results like hematology will be assessed.
Measured: Up to week 26
Change From Baseline in Simpson-Angus Scale (SAS)
SAS (Simpson-Angus Scale): is a 10-item rating scale for assessment of antipsychotic-induced parkinsonism in both clinical practice and research settings. Minimum: 0 (no symptoms) Maximum: 40 (very severe symptoms; 10 items scored 0-4 each).
Measured: Up to week 26
Change From Baseline in Abnormal Involuntary Movement Scale (AIMS)
AIMS (Abnormal Involuntary Movement Scale): assesses abnormal involuntary movements, such as tardive dyskinesia, associated with antipsychotic drugs; it measures facial, oral, extremities, and trunk movements, as well as the participant's awareness of abnormal movements. Minimum: 0 (no abnormal movements) Maximum: 42 (most severe; 7 items scored 0-4 each), some versions use 0-4 on 10 items for a max of 40/40.
Measured: Up to week 26
Change From Baseline in Barnes Akathisia Rating Scale (BARS)
BARS (Barnes Akathisia Rating Scale): is a 4-item rating scale used to assess drug-induced akathisia. The scale comprises items for rating the observable restless movements that characterize the condition, the subjective awareness of restlessness, and any distress associated with the akathisia. Minimum: 0 (no akathisia) Maximum: 14 (severe akathisia; 4 items scored, most items 0-3 or 0-5)
Measured: Up to week 26
Change from Baseline in Columbia-Suicide Severity Rating Scale (C-SSRS)
C-SSRS rates an individual's degree of suicidal ideation (SI) and behaviors on a scale, ranging from "wish to be dead" to "active suicidal ideation with specific plan and intent."
Measured: Up to week 26
Change From Baseline in the Epworth Sleepiness Scale (ESS)
ESS (Epworth Sleepiness Scale): is a scale that is intended to measure daytime sleepiness. Minimum: 0 (no sleepiness) Maximum: 24 (severe sleepiness; 8 items scored 0-3 each)
Measured: Up to week 26
Change From Baseline in the Young Mania Rating Scale (YMRS)
The YMRS (Young Mania Rating Scale): is an 11-item, clinician-rated scale that assesses manic symptoms based on the participant's perception of their condition over the previous 48 hours, as well as the physician's clinical observations during the interview. Minimum: 0 (no mania) Maximum: 60 (severe mania; 11 items, some scored 0-4, others 0-8)
Measured: Up to week 26
Number of Participants with Abnormal Change in Ocular Examination
Number of participants with abnormal change in ocular examinations in areas like best corrected visual acuity (BCVA), and refraction.
Measured: Up to week 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2025
- Study start30 Sep 2025
- Primary completionMar 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar I or II 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 84 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
- NCT07220460
- Sponsor's protocol ID
- M25-456
- Status last verified
- Sep 2026
- First submitted
- 26 Sep 2025
- Last updated
- 23 Sep 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.
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Open-label Study to Evaluate the Long-term Safety and Tolerability of ABBV-932 in Subjects With Depressive Episodes Associated With Bipolar I or II Disorder
- ClinicalTrials.gov ID
- NCT07220460
- Acronym / sponsor ID
- M25-456
- Conditions
- Bipolar I or II Disorder
- Keywords
- Bipolar I or II Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 84 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 30 Sep 2025 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 24 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Bipolar disorder is a severe chronic mood disorder that affects up to 4% of the adult population in the United States. The purpose of this study is to assess how safe and effective ABBV-932 is in treating participants with depressive episodes associated 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. Participants with bipolar I or II disorder who are currently experiencing a depressive episode will enter the study and be treated with open-label ABBV-932. Approximately 200 adult participants with bipolar I or II disorder will be enrolled in approximately 50 sites in the United States and Puerto Rico.
Participants will receive oral capsules of ABBV-932 for a 26-week treatment period. The treatment period will be followed by a safety follow-up (SFU) period of 30 days.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regularly scheduled 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ABBV-932 | Experimental | Drug: ABBV-932Participants will receive oral ABBV-932 for a 26-week treatment period followed by a 30-day follow-up |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Body Mass Index (BMI) >= 18.0 to <= 40.0 kg/m^2, inclusive.
- Participants who currently meet the Diagnostic and Statistical Manual of Mental Disorders treatment (DSM-5-TR) criteria for bipolar I or II disorder without psychotic features based on the Mini International Neuropsychiatric Interview (MINI 7.0.2), currently experiencing a depressive episode of at least 4 weeks and not exceeding 12 months.
- Normal physical examination findings, clinical laboratory test results, vital signs, and 12-lead ECG results at screening or abnormal results that are judged not clinically significant by the investigator and documented as such in the eCRF
- Participant with the following psychiatric history:
Key exclusion criteria (3 listed)
- A total score greater than 12 on the Young Mania Rating Scale (YMRS) at baseline.
- History of an allergic reaction or significant sensitivity to constituents of the study drug (and its excipients) and/or other products in the same class.
- A concurrent medical condition that might interfere with the conduct of the study, confound the interpretation of the study results, or endanger the subject's well-being. This includes any unstable condition, history or evidence of malignancy (other than treated basal or squamous cell carcinoma), or any significant hematologic, endocrine, cardiovascular, respiratory, renal impairment or disease (e.g., participants with eGFR < 30 mL/min), hepatic (including history of severe hepatic impairment), gastrointestinal, or neurological disorder. If there is a history of such disease (except malignancy), but the condition has been stable for more than 1 year, does not require treatment with prohibited medications, and is judged by the investigator not to interfere with participation in the study, the subject may be included.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ABBV-932Oral Capsule | Drug | ABBV-932 |
Primary outcome
Number of Participants Experiencing Adverse Events
Time frame: Up to approximately 29 weeks
An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
Number of Participants with Abnormal Change From Baseline in Vital Sign Measurements
Time frame: Up to week 26
Number of participants with abnormal change from baseline in vital sign measurements like systolic and diastolic blood pressure will be assessed.
Number of Participants with Change from Baseline in Electrocardiogram (ECG)
Time frame: Up to week 26
12-lead resting ECG will be recorded.
Number of Participants with Abnormal Change in Clinical Laboratory Test Results Like Hematology will be Assessed
Time frame: Up to week 26
Number of participants with abnormal change in clinical laboratory test results like hematology will be assessed.
Change From Baseline in Simpson-Angus Scale (SAS)
Time frame: Up to week 26
SAS (Simpson-Angus Scale): is a 10-item rating scale for assessment of antipsychotic-induced parkinsonism in both clinical practice and research settings. Minimum: 0 (no symptoms) Maximum: 40 (very severe symptoms; 10 items scored 0-4 each).
Change From Baseline in Abnormal Involuntary Movement Scale (AIMS)
Time frame: Up to week 26
AIMS (Abnormal Involuntary Movement Scale): assesses abnormal involuntary movements, such as tardive dyskinesia, associated with antipsychotic drugs; it measures facial, oral, extremities, and trunk movements, as well as the participant's awareness of abnormal movements. Minimum: 0 (no abnormal movements) Maximum: 42 (most severe; 7 items scored 0-4 each), some versions use 0-4 on 10 items for a max of 40/40.
Change From Baseline in Barnes Akathisia Rating Scale (BARS)
Time frame: Up to week 26
BARS (Barnes Akathisia Rating Scale): is a 4-item rating scale used to assess drug-induced akathisia. The scale comprises items for rating the observable restless movements that characterize the condition, the subjective awareness of restlessness, and any distress associated with the akathisia. Minimum: 0 (no akathisia) Maximum: 14 (severe akathisia; 4 items scored, most items 0-3 or 0-5)
Change from Baseline in Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: Up to week 26
C-SSRS rates an individual's degree of suicidal ideation (SI) and behaviors on a scale, ranging from "wish to be dead" to "active suicidal ideation with specific plan and intent."
Change From Baseline in the Epworth Sleepiness Scale (ESS)
Time frame: Up to week 26
ESS (Epworth Sleepiness Scale): is a scale that is intended to measure daytime sleepiness. Minimum: 0 (no sleepiness) Maximum: 24 (severe sleepiness; 8 items scored 0-3 each)
Change From Baseline in the Young Mania Rating Scale (YMRS)
Time frame: Up to week 26
The YMRS (Young Mania Rating Scale): is an 11-item, clinician-rated scale that assesses manic symptoms based on the participant's perception of their condition over the previous 48 hours, as well as the physician's clinical observations during the interview. Minimum: 0 (no mania) Maximum: 60 (severe mania; 11 items, some scored 0-4, others 0-8)
Number of Participants with Abnormal Change in Ocular Examination
Time frame: Up to week 26
Number of participants with abnormal change in ocular examinations in areas like best corrected visual acuity (BCVA), and refraction.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ABBVIE INC. study director
AbbVie
49 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ABBV-932 in people with Bipolar I or II Disorder, run by AbbVie at 49 sites in 2 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 8 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 49 sites in United States, 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. 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?
This study is still under way. Results are not available in the source record yet.
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?
Number of Participants Experiencing Adverse Events (time frame: Up to approximately 29 weeks). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Sep 2026.