ALTO-100 in Bipolar Disorder With Depression (BD-D)

StatusRecruiting
PhasePhase 2
Started

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Trial flagged as At Risk
Primary completion moved at least 12 months later Aug 2026 → Sep 2027
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Record History

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  1. Primary completion pushed from Aug 2026 to Sep 2027 Show 4 more changesShow less
    • Trial sites expanded: 27 → 68 locations
    • Study completion pushed from Oct 2026 to Oct 2027
    • Eligibility criteria expanded, about 12 words
    • Secondary endpoints: details revised at 5 of 9 entries
  2. Study sites: 15 to 27
    • Primary completion date: Aug 14, 2026 to Aug 2026
    • Study completion date: Oct 9, 2026 to Oct 2026
    • Eligibility criteria expanded, about 17 words
    v2
  3. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The purpose of this study is to assess antidepressant efficacy differences between ALTO-100 and placebo during the Double-Blind period in patients with bipolar disorder I or II with current major depressive episode, when used adjunctively to a mood stabilizer and/or atypical antipsychotic, related to patient characteristics. Additionally, safety, tolerability, and efficacy will be assessed in a subsequent open label treatment period.
Trial Details
NCT Number NCT06656416
Lead Sponsor Alto Neuroscience
Conditions
(from sponsor)		 Bipolar Disorder I or II With a Major Depressive Episode
Enrollment 200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov