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Study of ABBV-932 for Depressive Episodes in Bipolar I or II Disorder

This study is looking into a new oral capsule, ABBV-932, for adults experiencing depressive episodes linked to bipolar I or II disorder. Researchers want to understand how safe ABBV-932 is and if it helps improve these depressive episodes. You might be able to join if you are between 18 and 65 years old, have bipolar I or II disorder, and are currently having a depressive episode. The study will measure side effects, changes in vital signs (like blood pressure), and heart activity (ECG) over about 26 to 29 weeks. About 200 people will participate across the United States and Puerto Rico.

Study design
This is an interventional study where participants will receive ABBV-932 as an open-label treatment. Approximately 200 adult participants with bipolar I or II disorder will be enrolled.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be monitored for adverse events for up to approximately 29 weeks, and vital signs and ECG changes for up to week 26.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07220460

Study to Assess the Adverse Events of Oral ABBV-932 in Adult Participants With Depressive Episodes Associated With Bipolar I or II Disorder

Recruiting
PHASE2Ages 18–65InterventionalTreatment
AbbVie
~200 participants
Updated 2026-06-18 on ClinicalTrials.gov
What's tested:ABBV-932

At a glance

Recruiting sites
48 of 49 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Participants Experiencing Adverse Events
Measured over Up to approximately 29 weeks
+10 more outcomes measured

Conditions

Bipolar I or II Disorder

Explore related trials

Bipolar I disorderBipolar II Disorder

Where it's being run

49 sites across 23 states
California10
Florida8
Texas4
New York3
Georgia2
Nevada2
Ohio2
Washington2

Study leadership

  • ABBVIE INC. · STUDY_DIRECTOR · AbbVie

Who to contact

ABBVIE CALL CENTER
[email protected]
844-663-3742
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.

Exclusion

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.

What this trial measures

  • Number of Participants Experiencing Adverse EventsUp 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 MeasurementsUp 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)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 AssessedUp 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)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)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)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)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)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)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 ExaminationUp to week 26

    Number of participants with abnormal change in ocular examinations in areas like best corrected visual acuity (BCVA), and refraction.