Recruiting

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

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What is being tested

ABBV-932

Drug
Who is being recruted

Bipolar I or II Disorder

From 18 to 65 Years
+7 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: September 2025

See protocol details

Summary

Principal SponsorAbbVie
Study ContactABBVIE CALL CENTER
Last updated: November 3, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: September 30, 2025Actual date on which the first participant was enrolled.

This study focuses on evaluating the long-term safety and how well ABBV-932 works in treating depressive episodes in people with Bipolar I or II disorder. Bipolar disorder is a serious condition that can lead to significant mood changes, affecting many adults in the U.S. The aim is to provide a potential new treatment option that could improve the way depressive episodes in bipolar disorder are managed, helping to address a critical need for better therapies for those living with this challenging condition. Participants in this study are adults experiencing depressive episodes due to Bipolar I or II disorder. They will take ABBV-932 in the form of oral capsules for 26 weeks. This period is followed by a 30-day safety follow-up to carefully monitor how participants react to the drug. Throughout the study, participants will have regular hospital or clinic visits, where medical assessments, blood tests, and questionnaires will be used to track progress and any side effects. Although the study might require more frequent visits than usual care, the focus is on ensuring thorough monitoring for safety and effectiveness.

Official TitleMulticenter, 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 
Principal SponsorAbbVie
Study ContactABBVIE CALL CENTER
Last updated: November 3, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
200 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, all participants receive the same treatment. Since there is only one group, there is no need for randomization or assignment to different arms. This type of study is often used to test a new treatment without comparing it to another.

Other Ways to Assign Participants
Randomized allocation: Participants are assigned randomly, like flipping a coin, to ensure fairness and reduce bias.
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.

How treatments are given to participants
In this study, all participants receive the same treatment. This approach is often used to evaluate the effects of a single intervention without comparing it to another.

Other Ways to Assign Treatments
Parallel assignment: Participants are split into separate groups, each receiving a different treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 18 to 65 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Bipolar I or II Disorder
Criteria
4 inclusion criteria required to participate
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.
3 exclusion criteria prevent from participating
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 (subjects with eGFR \< 30 mL/min), hepatic (including history of severe hepatic impairment), gastrointestinal, or neurological disorder (if there is a history of such disease 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 in the study).
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 total score greater than 12 on the Young Mania Rating Scale (YMRS) at baseline.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
One single intervention group 

is designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
Experimental
Participants will receive oral ABBV-932 for a 26-week treatment period followed by a 30-day follow-up
Study Objectives
Primary Objectives

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 like systolic and diastolic blood pressure will be assessed.

12-lead resting ECG will be recorded.

Number of participants with abnormal change in clinical laboratory test results like hematology will be assessed.

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).

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.

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)

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."

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)

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 examinations in areas like best corrected visual acuity (BCVA), and refraction.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 14 locations
Recruiting
Collaborative Neuroscience Research - Garden Grove /ID# 273492Garden Grove, United StatesSee the location
Recruiting
Viking Clinical Research Center - Temecula /ID# 273471Temecula, United States
Recruiting
Cns Healthcare - Jacksonville /ID# 278332Jacksonville, United States
Recruiting
GMI Florida - Central Miami Medical Institute /ID# 273486Miami, United States
Recruiting
14 Study Centers