Skip to main content
UK clinical trials - updated daily from ClinicalTrials.gov
TrialConnect
← Back to Search
Looking for participantsPhase2

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

Sponsor: Alto Neuroscience

NCT ID: NCT07553637

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
ALTO-207 (drug), Placebo (drug)
How long the study runs
Study runs about 19 months (dates as stated)
About the drug or intervention
ALTO-207 — drug: ALTO-207 BID · Placebo — drug: Matching Placebo
Patient visit burden
Not specified by the sponsor

In plain English

This study is testing a medicine called ALTO-207 in adults aged 18 to 75 with treatment-resistant depression (TRD), which means depression that has not improved after trying at least two antidepressant treatments. The study is run by a company called Alto Neuroscience. Not stated — ask the trial team about the aims and how the medicine works.

Who can take part

  • Adults aged 18 to 75, of any gender
  • A diagnosis of moderate to severe major depressive disorder (MDD) without psychotic symptoms in the current episode
  • Depression that has not improved by at least half after 2 to 5 antidepressant treatments, including the current one
  • Currently taking a steady dose of 1 or 2 oral antidepressants

Who may not be able to

  • An unstable medical condition
  • Use of medicines not allowed in the study, or a substance use disorder
  • Bipolar disorder, a psychotic disorder, or psychotic symptoms
  • Significant post-traumatic stress disorder (PTSD) symptoms now, or PTSD in the past
  • Serious problems with controlling impulses at the moment
  • Past allergic reaction to ALTO-207 or anything in it
  • Taking part now, or recently, in another clinical trial for mental illness involving a new product or device

What taking part involves

  • • Not stated — ask the trial team

Time commitment: Not stated — ask the trial team about visits, duration, and what taking part involves.

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Testing a treatment
Ages
18 Years to 75 Years
Who
All
Number of participants
178
Started
2026-05
Last checked
2026-04

Plain English Summary

What is this study?

  • • Testing a new treatment for treatment-resistant depression (trd)
  • • Phase2 - 178 participants
  • • The purpose of this trial is to measure depressive symptoms following treatment with ALTO-207 compared with placebo in participants with TRD

Who can take part?

  • • Ages 18 Years to 75 Years
  • • Diagnosed with treatment-resistant depression (trd)

Where?

  • • Antrim - Site 7419
  • • Birmingham - Site 7411
  • • Bristol - Site 7414
  • • Cardiff - Site 7412
  • • +6 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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

Treatment-resistant Depression (TRD)

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years - 75 Years
  • Who can join: All genders

What the study is looking for

  • ✓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...
  • ✓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 take part

  • ✗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
See the full criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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

Where Is This Study? (10 UK sites)

Site 7419

Antrim, United Kingdom

NOT_YET_RECRUITING

Site 7411

Birmingham, United Kingdom

NOT_YET_RECRUITING

Site 7414

Bristol, United Kingdom

NOT_YET_RECRUITING

Site 7412

Cardiff, United Kingdom

NOT_YET_RECRUITING

Site 7418

Exeter, United Kingdom

NOT_YET_RECRUITING

Site 7415

London, United Kingdom

NOT_YET_RECRUITING

Site 7413

Nottingham, United Kingdom

NOT_YET_RECRUITING

Site 7410

Oxford, United Kingdom

NOT_YET_RECRUITING

Site 7402

Prescot, United Kingdom

NOT_YET_RECRUITING

Site 7416

Sheffield, United Kingdom

NOT_YET_RECRUITING

How to Get in Touch

Alto Neuroscience

Sponsor contact

CONTACT

650-200-0412 clinical@altoneuroscience.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-04