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Assessing the safety and effectiveness of ABBV-932 for treating bipolar disorder

Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Fixed-dose Study to Evaluate the Efficacy, Safety, and Tolerability of ABBV-932 in Subjects With Depressive Episodes Associated With Bipolar I or II Disorder

Phase 2 Interventional AbbVie · NCT06605599

This study is testing a new oral medication called ABBV-932 to see if it can help adults with bipolar disorder who are having a depressive episode feel better.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment160 (estimated)
Ages18 Years to 65 Years
SexAll
SponsorAbbVie Industry-sponsored
Locations40 sites (Dothan, Alabama and 39 other locations)
Trial IDNCT06605599 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and efficacy of ABBV-932, an investigational oral medication, in adults diagnosed with bipolar I or II disorder experiencing a depressive episode. Participants will be randomly assigned to receive either ABBV-932 or a placebo for a duration of six weeks, followed by a four-week safety follow-up period. The study aims to enroll approximately 160 participants across 40 sites worldwide, with regular weekly visits required during the treatment phase. The trial will assess adverse events and changes in disease activity using standardized rating scales.

Who should consider this trial

Good fit: Ideal candidates are adults diagnosed with bipolar I or II disorder who are currently experiencing a depressive episode lasting between 4 to 12 weeks.

Not a fit: Patients currently using psychoactive medications or those with a positive urine drug screen may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients suffering from bipolar disorder.

How similar studies have performed: While there have been various studies on bipolar disorder treatments, the specific approach with ABBV-932 is novel and has not been extensively tested in prior trials.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) criteria for bipolar I or II disorder without psychotic features based on the Mini International Neuropsychiatric Interview (MINI), with a current depressive episode of at least 4 weeks and not exceeding 12 months.
* Have a minimum score of 20 on the 17-item Hamilton Depression Rating Scale (HAMD-17).
* Have a minimum score of 2 on Item 1 of the HAMD-17 at screening.

Exclusion Criteria:

* Positive urine drug screen (UDS) result at screening.
* Treated with any investigational drug within 4 weeks or 5 half-lives of the drug (whichever is longer) prior to the first dose of study drug, is currently enrolled in another clinical study, or was previously enrolled in this study.
* Current use of any antipsychotic, antidepressant, anticonvulsant, mood stabilizer, herb, or over-the-counter medication with psychoactive potential within 1 week or 5 half-lives of the medication (whichever is longer).
* Prior exposure to ABBV-932 within 90 days prior to baseline.

Where this trial is running

Dothan, Alabama and 39 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 → Find more trials like this →
Conditions Bipolar I DisorderBipolar II DisorderBipolar DisorderABBV-932
Last reviewed 2026-06-13 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.