Study of Oral ABBV-932 to Assess Adverse Events and Change in Disease Activity in Adult Participants With Bipolar I or II Disorder

Launched by ABBVIE · Sep 18, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called ABBV-932 to see how safe and effective it is for adults with Bipolar I or II Disorder, particularly during depressive episodes. Bipolar disorder is a serious mental health condition that causes extreme mood swings, including episodes of depression. In this study, about 160 adult participants will be divided into four groups, where they will either receive the ABBV-932 capsules or a placebo (a pill that looks the same but has no active medication) once a day for six weeks. Participants will then have a four-week follow-up to monitor their safety and any side effects.

To be eligible for this trial, participants must meet specific criteria, including having a current depressive episode lasting at least four weeks and being diagnosed with bipolar disorder without psychotic features. Participants should be prepared for regular visits to a hospital or clinic for check-ups, which will include assessments, blood tests, and questionnaires to evaluate their mood and any side effects from the treatment. It's important to note that participants may have a higher treatment burden compared to their usual care, as the study involves more frequent monitoring and assessments.

Gender

ALL

Eligibility 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.