ALTO-100 in Bipolar Disorder With Depression (BD-D)
Public ClinicalTrials.gov record NCT06656416. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, Double-Blind, Placebo-Controlled Study Followed by Open-Label Treatment of ALTO-100 in Adults With Bipolar Disorder Currently Experiencing a Major Depressive Episode
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT06656416
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 200 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years to 70 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 2, 2024 (Actual)
- Primary completion
- Sep 2027 (Estimated)
- Completion
- Oct 2027 (Estimated)
- Last update posted
- Oct 13, 2026
2024 – 2027
United States locations
- U.S. sites
- 58
- U.S. states
- 24
- U.S. cities
- 51
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Site 6074 | Birmingham | Alabama | 35203 | Withdrawn |
| Site 6036 | Chandler | Arizona | 85224 | Withdrawn |
| Site 6000 | Phoenix | Arizona | 85012 | Recruiting |
| Site 6087 | Yuma | Arizona | 85364 | Withdrawn |
| 6039 | Fayetteville | Arkansas | 72703 | Withdrawn |
| 6070 | Little Rock | Arkansas | 72204 | Terminated |
| Site 6133 | Little Rock | Arkansas | 72211 | Recruiting |
| Site 6153 | Chino | California | 92056 | Recruiting |
| Site 6081 | Imperial | California | 92251 | Withdrawn |
| 6069 | Los Angeles | California | 90025 | Recruiting |
| Site 6016 | Mather | California | 95655 | Recruiting |
| Site 6082 | Oceanside | California | 92056 | Terminated |
| Site 6102 | Riverside | California | 92506 | Withdrawn |
| Site 6111 | Sacramento | California | 95817 | Recruiting |
| Site 6120 | San Jose | California | 95124 | Recruiting |
| Site 6112 | Colorado Springs | Colorado | 80910 | Recruiting |
| Site 6174 | Jacksonville | Florida | 32216 | Recruiting |
| Site 6067 | Lauderhill | Florida | 33319 | Withdrawn |
| Site 6123 | Pinellas Park | Florida | 33782 | Recruiting |
| Site 6015 | Tampa | Florida | 33629 | Recruiting |
| Site 6193 | Atlanta | Georgia | 30303 | Not yet recruiting |
| Site 6068 | Atlanta | Georgia | 30328 | Withdrawn |
| Site 6064 | Peachtree Corners | Georgia | 30071 | Recruiting |
| Site 6113 | Chicago | Illinois | 60611 | Recruiting |
| Site 6132 | Carmel | Indiana | 46032 | Recruiting |
| Site 6101 | West Lafayette | Indiana | 47906 | Terminated |
| Site 6151 | Baltimore | Maryland | 21229 | Withdrawn |
| Site 6076 | Bel Air | Maryland | 21015 | Recruiting |
| Site 6062 | Gaithersburg | Maryland | 20877 | Recruiting |
| Site 6182 | Towson | Maryland | 21204 | Recruiting |
| Site 6188 | Worcester | Massachusetts | 01608 | Recruiting |
| Site 6184 | Ann Arbor | Michigan | 48105 | Recruiting |
| Site 6155 | Ann Arbor | Michigan | 48109 | Recruiting |
| Site 6178 | Grand Rapids | Michigan | 49501 | Recruiting |
| Site 6122 | Flowood | Mississippi | 39232 | Recruiting |
| Site 6142 | Lincoln | Nebraska | 68526 | Withdrawn |
| Site 6144 | Las Vegas | Nevada | 89102 | Recruiting |
| Site 6104 | Las Vegas | Nevada | 89119 | Recruiting |
| Site 6066 | Toms River | New Jersey | 08755 | Recruiting |
| Site 6014 | Albuquerque | New Mexico | 87108 | Recruiting |
| Site 6078 | Albuquerque | New Mexico | 87110 | Withdrawn |
| Site 6170 | Amherst | New York | 14226 | Recruiting |
| Site 6137 | New York | New York | 10029 | Recruiting |
| Site 6127 | Cary | North Carolina | 27511 | Recruiting |
| Site 6187 | Rose Hill | North Carolina | 28458 | Recruiting |
| Site 6029 | Cincinnati | Ohio | 45215 | Recruiting |
| 6065 | North Canton | Ohio | 44720 | Terminated |
| Site 6075 | Westlake | Ohio | 44145 | Recruiting |
| Site 6116 | Austin | Texas | 78701 | Recruiting |
| Site 6105 | Beaumont | Texas | 77701 | Recruiting |
| Site 6176 | Dallas | Texas | 75243 | Recruiting |
| Site 6107 | Dallas | Texas | 75251 | Recruiting |
| Site 6175 | Houston | Texas | 77007 | Recruiting |
| Site 6072 | Houston | Texas | 77081 | Withdrawn |
| Site 6053 | Plano | Texas | 75093 | Recruiting |
| Site 6121 | Draper | Utah | 84020 | Withdrawn |
| Site 6177 | Fairfax | Virginia | 22030 | Recruiting |
| Site 6128 | Bellevue | Washington | 98004 | Terminated |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 10 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06656416, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 13, 2026 · Synced Oct 22, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT06656416 live on ClinicalTrials.gov.