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 63 sites in 2 countries.
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
- 63 sitesin 2 countries
- Study dates
- 20 May 2026to Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
63 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
63 sites in 2 countries
United States53 sites, 51 recruiting
- Recruiting
Site 7148
Albany, Georgia, 31707
- Recruiting
Site 7170
Amherst, New York, 14226
- Recruiting
Site 7155
Ann Arbor, Michigan, 48109
- Withdrawn
Site 7151
Annapolis, Maryland, 21401
- Not yet recruiting
Site 7199
Austin, Texas, 78731
- Not yet recruiting
Site 7185
Baltimore, Maryland, 21205
- Recruiting
Site 7154
Bloomfield Hills, Michigan, 48302
- Not yet recruiting
Site 7190
Bryan, Texas, 77802
- Recruiting
Site 7127
Cary, North Carolina, 27511
- Recruiting
Site 7055
Cedarhurst, New York, 11516
- Recruiting
Site 7143
Charlotte, North Carolina, 28287
- Recruiting
Site 7153
Chino, California, 91710
- Recruiting
Site 7029
Cincinnati, Ohio, 45215
- Recruiting
Site 7176
Dallas, Texas, 75243
- Not yet recruiting
Site 7194
Dayton, Ohio, 45459
- Recruiting
Site 7173
Dothan, Alabama, 36345
- Recruiting
Site 7172
East Providence, Rhode Island, 02914
- Recruiting
Site 7177
Fairfax, Virginia, 22030
- Recruiting
Site 7160
Fort Worth, Texas, 76104
- Not yet recruiting
Site 7150
Galveston, Texas, 77555
- Recruiting
Site 7158
Garfield Heights, Ohio, 44125
- Not yet recruiting
Site 7178
Grand Rapids, Michigan, 49501
- Recruiting
Site 7175
Houston, Texas, 77007
- Recruiting
Site 7145
Houston, Texas, 77030
- Recruiting
Site 7169
Indianapolis, Indiana, 46202
- Recruiting
Site 7161
Irving, Texas, 75062
- Not yet recruiting
Site 7195
La Jolla, California, 92037
- Recruiting
Site 7162
Lewiston, New York, 14092
- Recruiting
Site 7069
Los Angeles, California, 99025
- Recruiting
Site 7146
Marietta, Georgia, 30060
- Recruiting
Site 7192
Naperville, Illinois, 60563
- Not yet recruiting
Site 7191
North Myrtle Beach, South Carolina, 29582
- Recruiting
Site 7156
Oakland, California, 94610
- Recruiting
Site 7082
Oceanside, California, 92056
- Not yet recruiting
Site 7159
Palo Alto, California, 94304
- Recruiting
Site 7000
Phoenix, Arizona, 85012
- Recruiting
Site 7054
Pikesville, Maryland, 21208
- Recruiting
Site 7186
Plano, Texas, 75024
- Recruiting
Site 7180
Rockville, Maryland, 20852
- Recruiting
Site 7016
Sacramento, California, 95655
- Recruiting
Site 7152
Saint Augustine, Florida, 32086
- Recruiting
Site 7144
San Diego, California, 92123
- Recruiting
Site 7120
San Jose, California, 95124
- Recruiting
Site 7141
Savannah, Georgia, 31406
- Active, not recruiting
Site 7128
Seattle, Washington, 98004
- Recruiting
Site 7064
Snellville, Georgia, 30078
- Not yet recruiting
Site 7163
South Charleston, West Virginia, 25303
- Recruiting
Site 7189
St Louis, Missouri, 63128
- Recruiting
Site 7157
Syracuse, New York, 13210
- Recruiting
Site 7066
Toms River, New Jersey, 08755
- Recruiting
Site 7171
Valley Village, California, 91607
- Not yet recruiting
Site 7200
Wilton, Connecticut, 06897
- Recruiting
Site 7166
Worcester, Massachusetts, 01605
United Kingdom10 sites, 10 recruiting
- Not yet 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
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.
- Conditions
- Treatment-resistant Depression (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 group | Role | What they receive |
|---|---|---|
| ALTO-207 | Experimental | Not described Receives: Drug: ALTO-207 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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
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.
- First posted28 Apr 2026
- Study start20 May 2026
- Primary completionNov 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Treatment-resistant Depression (TRD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Alto Neuroscience
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07553637
- Sponsor's protocol ID
- ALTO-207-201
- Status last verified
- Oct 2026
- First submitted
- 31 Mar 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Trial of ALTO-207 in Adults With Treatment-resistant Depression
- ClinicalTrials.gov ID
- NCT07553637
- Acronym / sponsor ID
- ALTO-207-201
- Conditions
- Treatment-resistant Depression (TRD)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 178 participants (estimated)
- Lead sponsor
- Alto NeuroscienceIndustry (pharma, biotech, devices)
- Study start
- 20 May 2026 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 28 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this trial is to measure depressive symptoms following treatment with ALTO-207 compared with placebo in participants with TRD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ALTO-207 | Experimental | Drug: ALTO-207 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ALTO-207ALTO-207 BID | Drug | ALTO-207 |
| PlaceboMatching Placebo | Drug | Placebo |
Primary outcome
Change in the MADRS total score
Time frame: Change from baseline up to 8 weeks
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.
2 secondary outcomes
Change in response (≥50% improvement) raters based on MADRS
Time frame: Change from baseline up to 8 weeks
Change in the Clinician-administered CGI-S score over time from Baseline to Week 8
Time frame: Change from baseline up to 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
63 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ALTO-207 in people with Treatment-resistant Depression (TRD), run by Alto Neuroscience at 63 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 63 sites in United States, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alto Neuroscience (510-512-3668, clinical@altoneuroscience.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the MADRS total score (time frame: Change from baseline up to 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.