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Clinical Trial ● Currently Recruiting Phase II NCT06656416

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

ALTO-100 in Bipolar Disorder With Depression (BD-D) — Recruiting • Phase II • Mental Health / Psychiatry • NCT06656416.

📅 13 Oct 2026 ⏱ 1 min read
Currently Recruiting
This trial is actively seeking participants in the UK. Discuss eligibility with your patient before referring.
Status
Currently Recruiting
Phase
Phase II
NCT ID
NCT06656416
Start
2024-10-02
Completion
2027-09
ClinicaliQ Trial Snapshot
  • ALTO-100 in Bipolar Disorder With Depression (BD-D) — Recruiting • Phase II • Mental Health / Psychiatry • NCT06656416.
  • ALTO-100 tested against placebo for treating depression in bipolar disorder patients already on mood stabilizers or antipsychotics.

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What This Trial Is Studying

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. Conditions: Bipolar Disorder I or II With a Major Depressive Episode Interventions: ALTO-100, Placebo Lead Sponsor: Alto Neuroscience Planned Enrollment: 200 participants

Full Trial Details
View this trial on the source registry
Eligibility criteria, protocol, and results when available
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