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

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: January 22, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: September 30, 2025

Actual 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 
NCT07220460
Principal SponsorAbbVie
Study ContactABBVIE CALL CENTER
Last updated: January 22, 2026
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 enrolled

Total 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.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

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 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 (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).

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

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 35 locations

Recruiting

Ima Clinical Research Phoenix (Alea) /ID# 278047

Phoenix, United StatesSee the location
Recruiting

Advanced Research Center /ID# 273474

Anaheim, United States
Recruiting

Axiom Research /ID# 273482

Colton, United States
Recruiting

Collaborative Neuroscience Research - Garden Grove /ID# 273492

Garden Grove, United States
Recruiting
35 Study Centers