ALTO-100 in Bipolar Disorder With Depression (BD-D)
← catalyst calendarNCT06656416 · readout ≤ 12 d
Sponsored by Alto Neuroscience (industry) · ANRO — their whole pipeline →.
Phase
Phase 2
Status
Recruiting
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
200estimated
Sites
27
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 | 2024-10-02 | actual | When the study began enrolling |
| Primary completion | Aug 2026 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Oct 2026 | estimated | The whole study's end, after follow-up |
| First posted | 2024-10-24 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2025-07-16 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Bipolar Disorder I or II With a Major Depressive Episode
Interventions
- Drug: ALTO-100
- Drug: Placebo
Primary outcome
what the primary-completion date above is the date OFTo assess efficacy of ALTO-100 versus placebo on depression symptoms in bipolar disorder in a pre-defined subgroup of participants as measured by the mean change from Day 1 to Week 6 on the Montgomery-Åsberg Depression Rating Scale (MADRS) total score
measured Change assessed from Day 1 to Week 6
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