NCT06656416RecruitingPhase 2
ALTO-100 in Bipolar Disorder With Depression (BD-D)
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
Source: ClinicalTrials.gov · Last updated 13 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- First submitted
- 15 Oct 2024
- Start date
- 2 Oct 2024
- Primary completion date
- Sept 2027
- Lead sponsor
- Alto Neuroscience
- Diseases
- Bipolar disorder
- NCT number
- NCT06656416
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 200
- From 2 Oct 2024 to the primary completion date, Sept 2027
- 68 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concurrent use of any prohibited medications or substance use disorder
- Concurrent or recent participation in another clinical trial for mental illness involving an investigational product or device
Other illness
- Evidence of unstable medical condition
- 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
Who the study is looking for
- 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, asenapine, Iloperidone and Milsaperidone) 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
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (68)
Sites in registry order. Pick your city on the disease page to sort them by distance.
This page is information, not medical advice. Discuss any trial with your doctor.