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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 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. The trial reports 20 study locations across 9 states.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06656416
The ClinicalTrials.gov registry entry for NCT06656416 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Alto Neuroscience, which has 10 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 9 distinct geographic areas - top geographies include 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.
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