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NCT06656416 · ClinicalTrials.gov registry record · Phase 2
ALTO-100 in Bipolar Disorder With Depression (BD-D)
A Phase 2 study of Bipolar Disorder I or II With a Major Depressive Episode, sponsored by Alto Neuroscience.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 200
- Enrollment target
- 20
- Study locations
NCT06656416: Recruiting Phase 2 study of Bipolar Disorder I or II With a Major Depressive Episode, sponsored by Alto Neuroscience.
NCT06656416 is a Phase 2 study of Bipolar Disorder I or II With a Major Depressive Episode that is actively recruiting participants, run by Alto Neuroscience. The registered enrollment target is 200 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (50% higher). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06656416, a Phase 2 study of Bipolar Disorder I or II With a Major Depressive Episode, is actively recruiting participants, sponsored by Alto Neuroscience.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 200 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Primary Outcome
MADRS is a clinician-administered scale designed to measure depression severity and detects changes due to antidepressant treatment. The MADRS evaluates the following 10 items: apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. Each item is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total possible score
Conditions Studied
Interventions
- DRUG Placebo
- DRUG ALTO-100
Study Locations (20)
California
- Site 6081 - Imperial
- 6069 - Los Angeles
- Site 6016 - Mather
- Site 6082 - Oceanside
- Site 6102 - Riverside
Arizona
- Site 6036 - Chandler
- Site 6000 - Phoenix
- Site 6087 - Yuma
Maryland
- Site 6151 - Baltimore
- Site 6076 - Bel Air
- Site 6062 - Gaithersburg
Arkansas
- 6039 - Fayetteville
- 6070 - Little Rock
Georgia
- Site 6068 - Atlanta
- Site 6064 - Peachtree Corners
Nevada
- Site 6144 - Las Vegas
- Site 6104 - Las Vegas
Colorado
- Site 6112 - Colorado Springs
Florida
- Site 6067 - Lauderhill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2024-10-02 |
| Est. Completion | 2026-10 |
| Phase | Phase 2 |
What NCT06656416 shows while recruiting
NCT06656416 is an interventional study that assigns participants to a tested intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (50% higher).
The record links to 1 condition, with Bipolar Disorder I or II With a Major Depressive Episode appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06656416 names 20 study sites across 9 states, led by California, Arizona, Maryland.
Frequently Asked Questions
What is clinical trial NCT06656416 about?
NCT06656416 is a clinical study titled "ALTO-100 in Bipolar Disorder With Depression (BD-D)". 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 t...
What is the current status of trial NCT06656416?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 200 participants. The study started on 2024-10-02. Estimated completion is 2026-10.
What conditions does trial NCT06656416 study?
This clinical trial studies the following conditions: Bipolar Disorder I or II With a Major Depressive Episode.
What interventions are being tested in trial NCT06656416?
The interventions under investigation include: Placebo (DRUG), ALTO-100 (DRUG).
Who is sponsoring clinical trial NCT06656416?
This trial is sponsored by Alto Neuroscience, which has 10 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06656416 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06656416's enrollment target sits among peer trials
200 304th of 2000 higher than 1,653 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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