A Study to Assess Adverse Events and Change in Disease Activity of Oral Icalcaprant in Adult Participants With Bipolar I or II Disorder
← catalyst calendarNCT06696755 · readout ≤ 468 d
Sponsored by AbbVie (industry) · ABBV — their whole pipeline →.
Phase
Phase 2
Status
Recruiting
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
195estimated
Sites
33
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2026-02-03 | actual | When the study began enrolling |
| Primary completion | Nov 2027 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Nov 2027 | estimated | The whole study's end, after follow-up |
| First posted | 2024-11-20 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-08-14 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Bipolar I Disorder
- Bipolar II Disorder
Interventions
- Drug: Icalcaprant — also filed as ABBV-1354, CVL-354
- Drug: Placebo for Icalcaprant
Primary outcomes
what the primary-completion date above is the date OFChange from Baseline to Week 6 in the MADRS (Montgomery-Åsberg Depression Rating Scale) total score
measured Up to approximately Week 6
Number of Participants with Adverse Events (AEs)
measured Up to approximately 10 weeks
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