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Oral ABBV-932 treatment for depressive episodes in adults with Bipolar I or II disorder

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

PHASE2 · AbbVie · NCT07220460

This trial will try oral ABBV-932 in adults with Bipolar I or II who are currently having a depressive episode to see if it is safe and helps their mood.

Quick facts

PhasePHASE2
Study typeInterventional
Enrollment200 (estimated)
Ages18 Years to 65 Years
SexAll
SponsorAbbVie (industry)
Locations49 sites (Phoenix, Arizona and 48 other locations)
Trial IDNCT07220460 on ClinicalTrials.gov

What this trial studies

This Phase 2, open-label interventional trial will enroll about 200 adults with Bipolar I or II disorder experiencing a depressive episode at roughly 50 sites in the United States and Puerto Rico. Participants will receive oral ABBV-932 capsules for a 26-week treatment period, followed by a 30-day safety follow-up. Eligibility requires a current depressive episode lasting between 4 weeks and 12 months, BMI between 18 and 40 kg/m2, and no recent psychiatric hospitalization or lifetime psychotic disorders. The study will collect safety and tolerability data and monitor clinical status over the treatment period.

Who should consider this trial

Good fit: Adults with Bipolar I or II disorder currently in a depressive episode (lasting 4 weeks to 12 months), BMI 18.0–40.0 kg/m2, no recent psychiatric hospitalization, and no lifetime psychotic or neurocognitive disorders are ideal candidates.

Not a fit: People with current psychotic features, a history of schizophrenia or other psychotic disorders, recent psychiatric hospitalization, or major uncontrolled medical conditions are unlikely to be eligible or to benefit from this trial.

Why it matters

Potential benefit: If successful, ABBV-932 could become a new oral option to reduce depressive symptoms for adults with Bipolar I or II disorder.

How similar studies have performed: ABBV-932 is investigational with limited prior published data in bipolar depression, so this phase 2 trial represents an early test rather than confirmation of established success.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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).

Where this trial is running

Phoenix, Arizona and 48 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Bipolar I or II Disorder

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.