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Clinical Trials in the UK / NCT06656416
Recruiting Phase 2

ALTO-100 in Bipolar Disorder With Depression (BD-D)

NCT06656416 · tracked via the Priya Life Science UK tracker
Sponsor
Alto Neuroscience
Phase
Phase 2
Started
2024-10-02
Last updated
2025-07-16

Condition(s) studied

Bipolar Disorder I or II With a Major Depressive Episode

Investigational drug(s) / intervention(s)

ALTO-100Placebo

ALTO-100: ALTO-100 40 mg tablet BID

Placebo: Placebo tablet BID

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
Inclusion Criteria: * 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 Exclusion Criteria: * 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

Primary outcome measure(s)

  • To assess efficacy of ALTO-100 versus placebo on depression symptoms in bipolar disorder in a pre-defined subgroup of participants as measured by the mean change from Day 1 to Week 6 on the Montgomery-Åsberg Depression Rating Scale (MADRS) total score — Change assessed from Day 1 to Week 6
    MADRS is a clinician-administered scale designed to measure depression severity and detects changes due to antidepressant treatment. The MADRS evaluates the following 10 items: apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. Each item is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total possible score of 60. Higher scores represent a more severe condition.

Trial sites (27)

FacilityCityRegionStatus
Site 6036 Chandler Arizona Withdrawn
Site 6000 Phoenix Arizona Recruiting
Site 6087 Yuma Arizona Recruiting
6039 Fayetteville Arkansas Recruiting
6070 Little Rock Arkansas Recruiting
Site 6081 Imperial California Recruiting
6069 Los Angeles California Recruiting
Site 6016 Mather California Not Yet Recruiting
Site 6082 Oceanside California Recruiting
Site 6102 Riverside California Recruiting
Site 6112 Colorado Springs Colorado Not Yet Recruiting
Site 6067 Lauderhill Florida Withdrawn
Site 6068 Atlanta Georgia Recruiting
Site 6064 Peachtree Corners Georgia Recruiting
Site 6151 Baltimore Maryland Withdrawn
Site 6076 Bel Air Maryland Recruiting
Site 6062 Gaithersburg Maryland Recruiting
Site 6142 Lincoln Nebraska Recruiting
Site 6144 Las Vegas Nevada Recruiting
Site 6104 Las Vegas Nevada Recruiting
Site 6066 Toms River New Jersey Recruiting
Site 6014 Albuquerque New Mexico Not Yet Recruiting
Site 6078 Albuquerque New Mexico Recruiting
6065 North Canton Ohio Recruiting
Site 6075 Westlake Ohio Recruiting
Site 6072 Houston Texas Recruiting
Site 6121 Draper Utah Not Yet Recruiting

More Alto Neuroscience trials in the UK

ALTO-207 in Adults With Treatment-resistant Depression (TRD) Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06656416 on ClinicalTrials.gov ↗ ← All trials in the UK