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

Conditions

• Bipolar Disorder I or II With a Major Depressive Episode

Eligibility Criteria

Sex

ALL

Age

18 Years - 70 Years

Healthy Volunteers

Not accepted

Interventions

• ALTO-100 — DRUG
  ALTO-100 40 mg tablet BID
• Placebo — DRUG
  Placebo tablet BID

Study Details

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.

Key Dates

Start date

Oct 2, 2024

Status verified

Jul 2025

Primary completion

Aug 31, 2026

Completion

Oct 31, 2026

Study Design

Enrollment

200 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: ALTO-100
  Participants will receive ALTO-100 40 mg tablet twice daily, from Day 1 to Week 6 in the double blind (DB) treatment period. Eligible participants who enter the open label (OL) treatment period will receive ALTO-100 40 mg tablet twice daily from OL baseline until the end of OL period/early termination visit (Up to 7 weeks).
• Placebo Comparator: Placebo DB
  Participants will receive matching placebo tablet twice daily, from Day 1 to Week 6 in the double blind (DB) treatment period.

Primary Outcome Measure

To 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 [ Time Frame: Change assessed from Day 1 to Week 6 ]

Central Contacts

• Alto Neuroscience
  650-200-0412
  [email protected]

Locations (27)

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