Study to Assess the Adverse Events of Oral ABBV-932 in Adult Participants With Depressive Episodes Associated With Bipolar I or II Disorder

StatusActive, Not Recruiting
PhasePhase 2
SponsorAbbVie
Started

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Record History

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  1. Enrollment closed, study ongoing Show 4 more changesShow less
    • Final enrollment: 84 participants (planned 200)
    • Primary completion date: Apr 2027 to Mar 2027
    • Eligibility criteria expanded, about 11 words
    • Study sites revised (49)
  2. Eligibility criteria expanded, about 30 words
    • Study sites revised (49)
    v43
  3. Study sites: 48 to 49v42
  4. Study sites: 47 to 48v41
  5. 2 versions Re-verified since Mar 23, 2026, no change to tracked fieldsv39-v40
Show 37 earlier versionsHide 37 earlier versions
  1. Study sites: 46 to 47v38
  2. Re-verified, no change to tracked fieldsv37
  3. Study sites: 45 to 46v36
  4. Study sites: 43 to 45v35
  5. Re-verified, no change to tracked fieldsv34
  6. Study sites: 42 to 43v33
  7. Study sites: 41 to 42v32
  8. 2 versions Re-verified since Feb 10, 2026, no change to tracked fieldsv30-v31
  9. Study sites: 39 to 41v29
  10. Re-verified, no change to tracked fieldsv28
  11. Study sites: 37 to 39v27
  12. Study sites revised (37)v26
  13. 2 versions Re-verified since Jan 27, 2026, no change to tracked fieldsv24-v25
  14. Study sites: 35 to 37v23
  15. Re-verified, no change to tracked fieldsv22
  16. Study sites: 34 to 35v21
  17. Re-verified, no change to tracked fieldsv20
  18. Study sites: 33 to 34v19
  19. Re-verified, no change to tracked fieldsv18
  20. Study sites: 31 to 33v17
  21. Site details revised at 1 of 31 sitesv16
  22. Study sites: 30 to 31v15
  23. Study sites: 27 to 30v14
  24. Study sites: 26 to 27v13
  25. Re-verified, no change to tracked fieldsv12
  26. Study sites: 25 to 26v11
  27. Study sites: 23 to 25v10
  28. Study sites: 20 to 23v9
  29. Study sites: 18 to 20v8
  30. Study sites: 16 to 18v7
  31. Study sites: 15 to 16v6
  32. Study sites: 14 to 15v5
  33. Study sites: 13 to 14v4
  34. Study sites: 9 to 13v3
  35. Study sites: 1 to 9v2
  1. Study First Submitted
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
AbbVie
349 trials monitored
See 27 trials at risk
Bipolar Disorder
411 trials monitored
See 25 trials at risk
Bipolar disorder is a severe chronic mood disorder that affects up to 4% of the adult population in the United States. The purpose of this study is to assess how safe and effective ABBV-932 is in treating participants with depressive episodes associated with bipolar I or II disorder. ABBV-932 is an investigational drug being developed for the treatment of depressive episodes in adult participants with bipolar I or II disorder. Participants with bipolar I or II disorder who are currently experiencing a depressive episode will enter the study and be treated with open-label ABBV-932. Approximately 200 adult participants with bipolar I or II disorder will be enrolled in approximately 50 sites in the United States and Puerto Rico. Participants will receive oral capsules of ABBV-932 for a 26-week treatment period. The treatment period will be followed by a safety follow-up (SFU) period of 30 days. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regularly scheduled visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
Trial Details
NCT Number NCT07220460
Lead Sponsor AbbVie
Conditions
(from sponsor)		 Bipolar I or II Disorder
Enrollment 84 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov