ALTO-100 in Bipolar Disorder With Depression (BD-D)
Recruiting now · Phase 2 · Has a placebo group
Conditions studied: Bipolar Disorder I or II With a Major Depressive Episode
In brief
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 facts
- Study ID
- NCT06656416
- Run by
- Alto Neuroscience
- People needed
- 200
- Starts
- 2024-10-02
- Expected to finish
- 2026-10-01
- Last updated by the study team
- 2025-07-16
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Have a diagnosis of BD-I or BD-II as well as BD-D
- At baseline, taking a mood stabilizer, lithium (LI) or lamotrigine (LMG) or valproic acid (VPA, any form) or combination of Li + LMG or Li + VPA and/or taking an approved atypical antipsychotic medication (olanzapine, quetiapine, lurasidone, risperidone, ziprasidone, cariprazine, aripiprazole, lumateperone, and asenapine) for at least 6 weeks with no dose modifications in the past 2 weeks
- Willing to comply with all study assessments and procedures
- Must not be pregnant or breastfeeding at time of enrollment or throughout study
You may not qualify if…
- Evidence of unstable medical condition
- Concurrent use of any prohibited medications or substance use disorder
- Diagnosed psychotic disorder (other than mania or depression)
- Current moderate or severe substance use disorder
- Has a history of hypersensitivity or allergic reaction to ALTO-100 or any of its components/excipients
- Concurrent or recent participation in another clinical trial for mental illness involving an investigational product or device
Where it is running
- Site 6066 — Toms River, New Jersey, United States (enrolling)
- Site 6081 — Imperial, California, United States (enrolling)
- Site 6078 — Albuquerque, New Mexico, United States (enrolling)
- 6065 — North Canton, Ohio, United States (enrolling)
- Site 6075 — Westlake, Ohio, United States (enrolling)
- Site 6072 — Houston, Texas, United States (enrolling)
- 6069 — Los Angeles, California, United States (enrolling)
- Site 6000 — Phoenix, Arizona, United States (enrolling)
- Site 6082 — Oceanside, California, United States (enrolling)
- Site 6102 — Riverside, California, United States (enrolling)
- Site 6087 — Yuma, Arizona, United States (enrolling)
- 6039 — Fayetteville, Arkansas, United States (enrolling)
- Site 6068 — Atlanta, Georgia, United States (enrolling)
- Site 6064 — Peachtree Corners, Georgia, United States (enrolling)
- 6070 — Little Rock, Arkansas, United States (enrolling)
- Site 6076 — Bel Air, Maryland, United States (enrolling)
- Site 6062 — Gaithersburg, Maryland, United States (enrolling)
- Site 6142 — Lincoln, Nebraska, United States (enrolling)
- Site 6144 — Las Vegas, Nevada, United States (enrolling)
- Site 6104 — Las Vegas, Nevada, United States (enrolling)
- Site 6121 — Draper, Utah, United States
- Site 6016 — Mather, California, United States
- Site 6112 — Colorado Springs, Colorado, United States
- Site 6067 — Lauderhill, Florida, United States
- Site 6151 — Baltimore, Maryland, United States
Full record on ClinicalTrials.gov
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