Tests ALTO-100 for depression in adults with bipolar disorder
Compares ALTO-100 with a placebo in adults with bipolar depression.
Plain-language title generated from the registry record
Registry title: ALTO-100 in Bipolar Disorder With Depression (BD-D)
Key facts
- Where
- Derby, Edinburgh, Glasgow, Liverpool, London, Newcastle upon Tyne, Oxford, Southampton, and York, United KingdomSee the 10 sites
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 70 years old?
Source: NCT06656416, who can take part
Where in United Kingdom
- DerbyDerby, United KingdomTaking people
- EdinburghEdinburgh, United KingdomTaking people
- GlasgowGlasgow, United KingdomTaking people
- LiverpoolLiverpool, United KingdomTaking people
- LondonLondon, United KingdomTaking people
- LondonLondon, United KingdomTaking people
- Newcastle upon TyneNewcastle upon Tyne, United KingdomTaking people
- OxfordOxford, United KingdomTaking people
- SouthamptonSouthampton, United KingdomTaking people
- YorkYork, United KingdomTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Alto Neuroscience
- Trial code
- NCT06656416
- Record updated
- 13 October 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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.
Exclusion: 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; 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.