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Treatment-resistant Depression (TRD)Phase 2NCT07553637

ALTO-207 in Adults With Treatment-resistant Depression (TRD)

A Phase 2 study testing ALTO-207 in people with Treatment-resistant Depression (TRD), run by Alto Neuroscience at 48 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 trial is to measure depressive symptoms following treatment with ALTO-207 compared with placebo in participants with TRD. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Treatment-resistant Depression (TRD)
What is being tested?
ALTO-207
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
178 participants
Where
48 sitesin 2 countries
Study dates
May 2026to Dec 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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male and female participants, ages 18 to 75 years, inclusive, at the time of signing the ICF.
  • Prior diagnosis of MDD without psychotic symptoms (in the current episode) and have confirmatory diagnosis of current MDD (moderate to severe).
  • Failure to respond (<50% improvement) to at least 2-5 antidepressant treatments (including the current treatment)
  • Currently taking a stable dose of at least 1 but no more than 2 oral antidepressants at baseline

Who cannot join

  • Evidence of unstable medical condition
  • Concurrent use of any prohibited medications or substance use disorder
  • Diagnosed bipolar disorder or a psychotic disorder or symptoms
  • Significant current PTSD symptoms or history of PTSD
  • Clinically significant current impulse control difficulties
  • Has a history of hypersensitivity or allergic reaction to ALTO-207 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

48 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

48 sites in 2 countries

United States38 sites, 38 recruiting

  • Site 7148

    Albany, Georgia, 31707

    Recruiting

  • Site 7170

    Amherst, New York, 14226

    Not yet recruiting

  • Site 7155

    Ann Arbor, Michigan, 48109

    Not yet recruiting

  • Site 7151

    Annapolis, Maryland, 21401

    Recruiting

  • Site 7146

    Atlanta, Georgia, 30060

    Not yet recruiting

  • Site 7074

    Birmingham, Alabama, 35294

    Not yet recruiting

  • Site 7154

    Bloomfield Hills, Michigan, 48302

    Recruiting

  • Site 7055

    Cedarhurst, New York, 11516

    Not yet recruiting

  • Site 7143

    Charlotte, North Carolina, 28287

    Recruiting

  • Site 7153

    Chino, California, 91710

    Not yet recruiting

  • Site 7029

    Cincinnati, Ohio, 45215

    Recruiting

  • Site 7176

    Dallas, Texas, 75243

    Not yet recruiting

  • Site 7173

    Dothan, Alabama, 36345

    Not yet recruiting

  • Site 7172

    East Providence, Rhode Island, 02914

    Not yet recruiting

  • Site 7177

    Fairfax, Virginia, 22030

    Not yet recruiting

  • Site 7160

    Fort Worth, Texas, 76104

    Not yet recruiting

  • Site 7150

    Galveston, Texas, 77555

    Not yet recruiting

  • Site 7158

    Garfield Heights, Ohio, 44125

    Not yet recruiting

  • Site 7175

    Houston, Texas, 77007

    Not yet recruiting

  • Site 7145

    Houston, Texas, 77030

    Recruiting

  • Site 7169

    Indianapolis, Indiana, 46202

    Not yet recruiting

  • Site 7161

    Irving, Texas, 75062

    Recruiting

  • Site 7162

    Lewiston, New York, 14214

    Not yet recruiting

  • Site 7156

    Oakland, California, 94610

    Not yet recruiting

  • Site 7082

    Oceanside, California, 92056

    Recruiting

  • Site 7159

    Palo Alto, California, 94304

    Not yet recruiting

  • Site 7064

    Peachtree Corners, Georgia, 30078

    Not yet recruiting

  • Site 7000

    Phoenix, Arizona, 85012

    Recruiting

  • Site 7054

    Pikesville, Maryland, 21208

    Not yet recruiting

  • Site 7016

    Sacramento, California, 95655

    Not yet recruiting

  • Site 7152

    Saint Augustine, Florida, 32086

    Recruiting

  • Site 7144

    San Diego, California, 92123

    Recruiting

  • Site 7141

    Savannah, Georgia, 31406

    Recruiting

  • Site 7128

    Seattle, Washington, 98004

    Not yet recruiting

  • Site 7163

    South Charleston, West Virginia, 25303

    Not yet recruiting

  • Site 7157

    Syracuse, New York, 13210

    Not yet recruiting

  • Site 7171

    Valley Village, California, 91607

    Not yet recruiting

  • Site 7166

    Worcester, Massachusetts, 01606

    Not yet recruiting

Other trials in United States

United Kingdom10 sites, 10 recruiting

  • Site 7419

    Antrim

    Not yet recruiting

  • Site 7411

    Birmingham

    Not yet recruiting

  • Site 7414

    Bristol

    Not yet recruiting

  • Site 7412

    Cardiff

    Not yet recruiting

  • Site 7418

    Exeter

    Not yet recruiting

  • Site 7415

    London

    Not yet recruiting

  • Site 7413

    Nottingham

    Not yet recruiting

  • Site 7410

    Oxford

    Not yet recruiting

  • Site 7402

    Prescot

    Not yet recruiting

  • Site 7416

    Sheffield

    Not yet recruiting

Other trials in United Kingdom

About this study

Official title: A Randomized, Double-blind, Placebo-controlled Trial of ALTO-207 in Adults With Treatment-resistant Depression

The purpose of this trial is to measure depressive symptoms following treatment with ALTO-207 compared with placebo in participants with TRD.

Being tested
ALTO-207, Placebo
Medical subject headings
Depressive Disorder, Treatment-Resistant

What participants receive

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

  • ALTO-207Drug

    ALTO-207 BID

  • PlaceboDrug

    Matching Placebo

Study groups in NCT07553637
Study groupRoleWhat they receive
ALTO-207ExperimentalNot described
Receives: Drug: ALTO-207
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

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

  1. Change in the MADRS total score

    Montgomery Asberg Depression Rating Scale (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 from baseline up to 8 weeks

Secondary outcomes (2)

  1. Change in response (≥50% improvement) raters based on MADRS

    Montgomery Asberg Depression Rating Scale (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 from baseline up to 8 weeks

  2. Change in the Clinician-administered CGI-S score over time from Baseline to Week 8

    The Clinician Global Impression-Severity scale (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: Change from baseline up to 8 weeks

Timeline

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

  1. First posted28 Apr 2026
  2. Study startMay 2026 (estimated)
  3. Primary completionNov 2027 (estimated)
  4. Study completionDec 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
178 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07553637
Sponsor's protocol ID
ALTO-207-201
Status last verified
Apr 2026
First submitted
31 Mar 2026
Last updated
28 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

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