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Bipolar Disorder I or II With a Major Depressive EpisodePhase 2NCT06656416

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

A Phase 2 study testing ALTO-100 in people with Bipolar Disorder I or II With a Major Depressive Episode, run by Alto Neuroscience at 68 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record

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Trial 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… Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
ALTO-100
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
200 participants
Where
68 sitesin 2 countries
Study dates
2 Oct 2024to Oct 2027
Phase
Phase 2

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

68 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Alto Neuroscience contact

650-200-0412

clinical@altoneuroscience.com

68 sites in 2 countries

United States58 sites, 40 recruiting

  • Site 6014

    Albuquerque, New Mexico, 87108

    Recruiting

  • Site 6078

    Albuquerque, New Mexico, 87110

    Withdrawn

  • Site 6170

    Amherst, New York, 14226

    Recruiting

  • Site 6184

    Ann Arbor, Michigan, 48105

    Recruiting

  • Site 6155

    Ann Arbor, Michigan, 48109

    Recruiting

  • Site 6193

    Atlanta, Georgia, 30303

    Not yet recruiting

  • Site 6068

    Atlanta, Georgia, 30328

    Withdrawn

  • Site 6116

    Austin, Texas, 78701

    Recruiting

  • Site 6151

    Baltimore, Maryland, 21229

    Withdrawn

  • Site 6105

    Beaumont, Texas, 77701

    Recruiting

  • Site 6076

    Bel Air, Maryland, 21015

    Recruiting

  • Site 6128

    Bellevue, Washington, 98004

    Terminated

  • Site 6074

    Birmingham, Alabama, 35203

    Withdrawn

  • Site 6132

    Carmel, Indiana, 46032

    Recruiting

  • Site 6127

    Cary, North Carolina, 27511

    Recruiting

  • Site 6036

    Chandler, Arizona, 85224

    Withdrawn

  • Site 6113

    Chicago, Illinois, 60611

    Recruiting

  • Site 6153

    Chino, California, 92056

    Recruiting

  • Site 6029

    Cincinnati, Ohio, 45215

    Recruiting

  • Site 6112

    Colorado Springs, Colorado, 80910

    Recruiting

  • Site 6176

    Dallas, Texas, 75243

    Recruiting

  • Site 6107

    Dallas, Texas, 75251

    Recruiting

  • Site 6121

    Draper, Utah, 84020

    Withdrawn

  • Site 6177

    Fairfax, Virginia, 22030

    Recruiting

  • 6039

    Fayetteville, Arkansas, 72703

    Withdrawn

  • Site 6122

    Flowood, Mississippi, 39232

    Recruiting

  • Site 6062

    Gaithersburg, Maryland, 20877

    Recruiting

  • Site 6178

    Grand Rapids, Michigan, 49501

    Recruiting

  • Site 6175

    Houston, Texas, 77007

    Recruiting

  • Site 6072

    Houston, Texas, 77081

    Withdrawn

  • Site 6081

    Imperial, California, 92251

    Withdrawn

  • Site 6174

    Jacksonville, Florida, 32216

    Recruiting

  • Site 6144

    Las Vegas, Nevada, 89102

    Recruiting

  • Site 6104

    Las Vegas, Nevada, 89119

    Recruiting

  • Site 6067

    Lauderhill, Florida, 33319

    Withdrawn

  • Site 6142

    Lincoln, Nebraska, 68526

    Withdrawn

  • 6070

    Little Rock, Arkansas, 72204

    Terminated

  • Site 6133

    Little Rock, Arkansas, 72211

    Recruiting

  • 6069

    Los Angeles, California, 90025

    Recruiting

  • Site 6016

    Mather, California, 95655

    Recruiting

  • Site 6137

    New York, New York, 10029

    Recruiting

  • 6065

    North Canton, Ohio, 44720

    Terminated

  • Site 6082

    Oceanside, California, 92056

    Terminated

  • Site 6064

    Peachtree Corners, Georgia, 30071

    Recruiting

  • Site 6000

    Phoenix, Arizona, 85012

    Recruiting

  • Site 6123

    Pinellas Park, Florida, 33782

    Recruiting

  • Site 6053

    Plano, Texas, 75093

    Recruiting

  • Site 6102

    Riverside, California, 92506

    Withdrawn

  • Site 6187

    Rose Hill, North Carolina, 28458

    Recruiting

  • Site 6111

    Sacramento, California, 95817

    Recruiting

  • Site 6120

    San Jose, California, 95124

    Recruiting

  • Site 6015

    Tampa, Florida, 33629

    Recruiting

  • Site 6066

    Toms River, New Jersey, 08755

    Recruiting

  • Site 6182

    Towson, Maryland, 21204

    Recruiting

  • Site 6101

    West Lafayette, Indiana, 47906

    Terminated

  • Site 6075

    Westlake, Ohio, 44145

    Recruiting

  • Site 6188

    Worcester, Massachusetts, 01608

    Recruiting

  • Site 6087

    Yuma, Arizona, 85364

    Withdrawn

Other trials in United States

United Kingdom10 sites, 10 recruiting

  • Site 6409

    Derby, DE22 3LZ

    Recruiting

  • Site 6403

    Edinburgh, EH16 4SA

    Recruiting

  • Site 6401

    Glasgow, G51 4TF

    Recruiting

  • Site 6402

    Liverpool, L7 8XP

    Recruiting

  • Site 6408

    London, NW1 0PE

    Recruiting

  • Site 6407

    London, SE1 9RT

    Recruiting

  • Site 6400

    Newcastle upon Tyne, DE22 3LZ

    Recruiting

  • Site 6404

    Oxford, OX1 5RP

    Recruiting

  • Site 6406

    Southampton, SO14 3DT

    Recruiting

  • Site 6405

    York, YO31 8TA

    Recruiting

Other trials in United Kingdom

About this study

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

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.

Being tested
ALTO-100, Placebo
Keywords
Bipolar I, Bipolar II, Major Depressive Episode

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ALTO-100Drug

    ALTO-100 40 mg tablet BID

  • PlaceboDrug

    Placebo tablet BID

Study groups in NCT06656416
Study groupRoleWhat they receive
ALTO-100ExperimentalParticipants will receive ALTO-100 40 mg tablet twice daily, from Day 1 to Week 6 in the double blind (DB) treatment period. Eligible participants who enter the open label (OL) treatment period will receive ALTO-100 40 mg tablet twice daily from OL baseline until the end of OL period/early termination visit (Up to 7 weeks).
Receives: Drug: ALTO-100
Placebo DBPlacebo comparatorParticipants will receive matching placebo tablet twice daily, from Day 1 to Week 6 in the double blind (DB) treatment period.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    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.

    Measured: Change assessed from Day 1 to Week 6

Secondary outcomes (9)

  1. To assess efficacy of ALTO-100 vs placebo for self-reported depressive symptoms in bipolar disorder patients in a pre- defined subgroup of participants as measured by the change from Day 1 to Week 6 in Patient Health Questionnaire, 9 item (PHQ-9)

    The PHQ-9 is a 9-item, participant reported outcome measure to assess depressive symptoms. The scale scores each of the 9 symptom domains of the diagnostic and statistical manual of mental disorders-5th edition (DSM-5) major depressive disorder (MDD) criteria. Each item is rated on a 4- point scale (0=not at all, 1=several days, 2=more than half the days, and 3=nearly every day). The participant's item responses are summed to provide a total score (range of 0 to 27), with higher scores indicating greater severity of depressive symptoms.

    Measured: Assessed 4 times over a 6-week interval, from Day 1 to Week 6

  2. To assess efficacy of ALTO-100 vs placebo in severity of bipolar disorder symptoms in a pre-defined subgroup of participants as measured by the change from Day 1 to Week 6 in Clinician Global Impression Scale-severity (CGI-S)

    The CGI-S is a 7-point global assessment scale that measures the clinician's impression of the severity of illness exhibited by a participant, rating according to: 1=normal (not at all ill); 2=borderline ill; 3=mildly ill; 4=moderately ill;5=markedly ill; 6=severely ill; and 7=among the most extremely ill participants. Higher scores represent a more severe condition.

    Measured: Assessed 4 times over a 6-week interval, from Day 1 to Week 6

  3. To assess efficacy of ALTO-100 vs placebo for depressive symptoms in MDD in a pre-defined subgroup as measured by the change from Day 1 to Week 6 in response (>50% improvement from baseline) and remission (total score of <10) rates based on MADRS

    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.

    Measured: Assessed 4 times over a 6-week interval, from Day 1 to Week 6

  4. To assess efficacy of ALTO-100 vs placebo on depressive symptoms in bipolar disorder in all randomized participants as measured by the change from Day 1 to Week 6 on the MADRS

    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.

    Measured: Assessed 4 times over a 6-week interval, from Day 1 to Week 6

  5. To evaluate the safety of ALTO-100 during both the DB and OL periods of the study as measured by the assessment of the incidence, severity, and relatedness of Treatment Emergent Adverse Events (TEAEs), SAEs, discontinuation due to TEAEs and deaths

    Measured: Assessed from Day 1 to Week 13

  6. To evaluate the safety of ALTO-100 during both the DB and OL periods of the study as measured by the assessment of Heart Rate in bpm

    Assessment of Heart Rate in bpm

    Measured: Assessed from Day 1 to Week 13

  7. To evaluate the safety of ALTO-100 during both the DB and OL periods of the study as measured by the assessment of Blood Pressure in mmHg

    Assessment of Blood Pressure in mmHg

    Measured: Assessed from Day 1 to Week 13

  8. To evaluate the safety of ALTO-100 during both the DB and OL periods of the study as measured by the assessment of Weight in pounds

    Assessment of Weight in pounds

    Measured: Assessed from Day 1 to Week 13

  9. To evaluate the safety of ALTO-100 during both the DB and OL periods of the study as measured by the assessment of suicidality with the Concise Health Risk Tracking Self-Report,12 item scale (CHRT-SR12)

    The CHRT is a brief, self-report measure that systematically assesses both suicidal thinking and associated thoughts that may indicate the propensity for suicidal acts. The CHRT-SR12 is a 12 item scale. The patient assigns a score of 0-4for each item of the scale, allowing for a total score of 0 to 48, with the higher score signifying more severe symptoms.

    Measured: Assessed from Day 1 to Week 13

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Oct 2024
  2. Study start2 Oct 2024
  3. Primary completionSep 2027 (estimated)
  4. Study completionOct 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06656416
Sponsor's protocol ID
ALTO-100-211
Status last verified
Oct 2026
First submitted
15 Oct 2024
Last updated
13 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

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