Major Depressive DisorderPhase 2NCT05118750
ALTO-300 in Depression
A Phase 2 study testing ALTO-300 oral (PO) tablet in people with Major Depressive Disorder, run by Alto Neuroscience at 11 sites in United States.
Trial summary
The purpose of this study is to collect biologically-based data for defining predictors and correlates of the effects of ALTO-300. Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- ALTO-300 oral (PO) tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 11 sitesUnited States
- Study dates
- 13 Dec 2021to 9 May 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- have a diagnosis of MDD based on the Structured Clinical Interview for DSM-5 (SCID) for depression
- have moderate to severe depression on DSM-5 depression criteria items, as assessed by a score of ≥10 on the Patient Health Questionnaire-9 (PHQ-9) at each of Visits 1, 2, and 3
- at baseline (Visit 2) are taking a stable dose of a single SSRI, serotonin-norepinephrine reuptake inhibitor (SNRI), or bupropion and have been on that medication for ≥6 weeks at an adequate dosage defined by the Antidepressant Treatment Response Questionnaire (ATRQ), and with no modification to dosage for ≥2 weeks.
- have either: had a continuous period of euthymia of at least 2 months in the past 26 months, regardless of the number of failed antidepressants OR not had a period of euthymia of at least 2 months in the past 26 months but within the past 24 months have not failed >3 antidepressants at an adequate dosage and duration as defined by the ATRQ
- are currently on their last failed currently prescribed permitted baseline antidepressant medication
- have a response to their currently prescribed antidepressant noted as depression that has improved ≤49% as defined by the ATRQ.
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- agree to, and are eligible for all biomarker assessments (EEG, neurocognitive testing, activity and sleep monitoring, genetic testing). To participate in the activity and sleep monitoring biomarkers, all participants will be required to have a smart phone or an internet enabled tablet. A participant who otherwise qualifies may refuse the salivary genetic sample and be included in the study.
- fluent in English
- willing to comply with all study procedures (with the notes above), able to complete all assessments independently, and available for the duration of the study.
Who cannot join
- Any of the following medical conditions:
- hepatic impairment (i.e., cirrhosis or active/chronic liver disease)
- baseline serum transaminase levels that exceed 2x upper limit of normal(ULN)
- severe impediment to vision, hearing, comprehension, and/or hand movement that interferes with study tasks.
- any contraindications to EEG (i.e., requiring high concentration oxygen)
- active suicidal ideation as assessed by the investigator.
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- moderate to severe Alcohol Use Disorder (AUD)
- Concurrent use of any of the following at baseline (Visit 2):
- tricyclic antidepressants (TCAs), mirtazapine, or monoamine oxidase inhibitors (MAOIs)
- melatonin, ramelteon, or other melatonin agonist
- a potent CYP1A2 inhibitor (e.g., fluvoxamine and ciprofloxacin)
- antipsychotics or mood stabilizers
- hypnotics, anxiolytics, stimulants, or opiate pain medications greater than three days per week and unable to reduce use to 3 or fewer days per week on an as needed basis
- Have received electroconvulsive therapy (ECT), deep brain stimulation (DBS),vagus nerve stimulation (VNS), >2 treatments with ketamine, or esketamine in thecurrent depressive episode.
- Diagnosis of bipolar disorder or a psychotic disorder based on the SCID forDSM-5
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Site 159
Clermont, Florida, 34711
Site 153
Culver City, California, 90230
Site 102
Dallas, Texas, 75235
Site 165
DeSoto, Texas, 75115
Site 147
Fort Worth, Texas, 76104
Site 132
New York, New York, 10023
Site 137
Noblesville, Indiana, 46060
Site 161
Okeechobee, Florida, 34972
Site 103
Sacramento, California, 95757
Site 166
Saint Charles, Missouri, 63304
Site 158
Santee, California, 92071
About this study
Official title: An Open-label Study of ALTO-300 in Adults With Major Depressive Disorder
The purpose of this study is to collect biologically-based data for defining predictors and correlates of the effects of ALTO-300.
- Conditions
- Major Depressive Disorder
- Being tested
- ALTO-300 oral (PO) tablet
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALTO-300 oral (PO) tabletDrug
One tablet daily
| Study group | Role | What they receive |
|---|---|---|
| ALTO-300 | Experimental | ALTO-300 oral (PO) tablet; daily dosing 8 weeks Receives: Drug: ALTO-300 oral (PO) tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
To understand the relationship between baseline biology and clinical outcome to ALTO-300 using the Montgomery-Åsberg Depression Rating Scale (MADRS)
The Montgomery-Åsberg Depression Rating Scale (MADRS) measures the severity of depression where smaller scores indicate less depression and higher scores suggest more severe depression. Possible scores for this 10 item version range from 0 to 60. The change from baseline to the end of the study is the primary outcome.
Measured: Measured 6 times over 8 weeks
To understand the relationship between baseline biology and clinical outcome to ALTO-300 using the Clinical Global Impression scale - Severity (CGI-S)
The Clinical Global Impression scale - Severity (CGI-S) measures the severity of psychopathology in general where smaller scores indicate less illness and higher scores suggest more severe illness. Possible scores for this scale range from 1 to 7. The change from baseline to the end of the study is the primary outcome.
Measured: Measured 6 times over 8 weeks
To evaluate the safety of ALTO-300
Incidence, severity, and relatedness of TEAEs,SAEs, discontinuation due to TEAEs, and deaths
Measured: From the signing of the ICF until the follow-up visit (up to 12 weeks)
To evaluate the safety of ALTO-300
Assessment of vital signs and laboratory data, withparticular attention to liver function tests
Measured: From the signing of the ICF until the end-of-treatment visit (up to 11 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2021
- Study start13 Dec 2021
- Primary completion5 May 2023
- Study completion9 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alto Neuroscience
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05118750
- Sponsor's protocol ID
- ALTO-300-002
- Status last verified
- Apr 2024
- First submitted
- 18 Oct 2021
- Last updated
- 30 Apr 2024
- 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 30 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Study of ALTO-300 in Adults With Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT05118750
- Acronym / sponsor ID
- ALTO-300-002
- Conditions
- Major Depressive Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Alto NeuroscienceIndustry (pharma, biotech, devices)
- Study start
- 13 Dec 2021 (actual)
- Primary completion
- 5 May 2023 (actual)
- Study completion
- 9 May 2023 (actual)
- First posted
- 12 Nov 2021 (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 study is to collect biologically-based data for defining predictors and correlates of the effects of ALTO-300.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ALTO-300 | Experimental | Drug: ALTO-300 oral (PO) tabletALTO-300 oral (PO) tablet; daily dosing 8 weeks |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- have a diagnosis of MDD based on the Structured Clinical Interview for DSM-5 (SCID) for depression
- have moderate to severe depression on DSM-5 depression criteria items, as assessed by a score of ≥10 on the Patient Health Questionnaire-9 (PHQ-9) at each of Visits 1, 2, and 3
- at baseline (Visit 2) are taking a stable dose of a single SSRI, serotonin-norepinephrine reuptake inhibitor (SNRI), or bupropion and have been on that medication for ≥6 weeks at an adequate dosage defined by the Antidepressant Treatment Response Questionnaire (ATRQ), and with no modification to dosage for ≥2 weeks.
- have either: had a continuous period of euthymia of at least 2 months in the past 26 months, regardless of the number of failed antidepressants OR not had a period of euthymia of at least 2 months in the past 26 months but within the past 24 months have not failed >3 antidepressants at an adequate dosage and duration as defined by the ATRQ
- are currently on their last failed currently prescribed permitted baseline antidepressant medication
Key exclusion criteria (15 listed)
- hepatic impairment (i.e., cirrhosis or active/chronic liver disease)
- baseline serum transaminase levels that exceed 2x upper limit of normal(ULN)
- severe impediment to vision, hearing, comprehension, and/or hand movement that interferes with study tasks.
- any contraindications to EEG (i.e., requiring high concentration oxygen)
- active suicidal ideation as assessed by the investigator.
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-300 oral (PO) tabletOne tablet daily | Drug | ALTO-300 |
Primary outcome
To understand the relationship between baseline biology and clinical outcome to ALTO-300 using the Montgomery-Åsberg Depression Rating Scale (MADRS)
Time frame: Measured 6 times over 8 weeks
The Montgomery-Åsberg Depression Rating Scale (MADRS) measures the severity of depression where smaller scores indicate less depression and higher scores suggest more severe depression. Possible scores for this 10 item version range from 0 to 60. The change from baseline to the end of the study is the primary outcome.
To understand the relationship between baseline biology and clinical outcome to ALTO-300 using the Clinical Global Impression scale - Severity (CGI-S)
Time frame: Measured 6 times over 8 weeks
The Clinical Global Impression scale - Severity (CGI-S) measures the severity of psychopathology in general where smaller scores indicate less illness and higher scores suggest more severe illness. Possible scores for this scale range from 1 to 7. The change from baseline to the end of the study is the primary outcome.
To evaluate the safety of ALTO-300
Time frame: From the signing of the ICF until the follow-up visit (up to 12 weeks)
Incidence, severity, and relatedness of TEAEs,SAEs, discontinuation due to TEAEs, and deaths
To evaluate the safety of ALTO-300
Time frame: From the signing of the ICF until the end-of-treatment visit (up to 11 weeks)
Assessment of vital signs and laboratory data, withparticular attention to liver function tests
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2024.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ALTO-300 oral (PO) tablet in people with Major Depressive Disorder, run by Alto Neuroscience at 11 sites in United States.
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 9 inclusion and 15 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: finished, as of the sponsor's last update on 30 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To understand the relationship between baseline biology and clinical outcome to ALTO-300 using the Montgomery-Åsberg Depression Rating Scale (MADRS) (time frame: Measured 6 times over 8 weeks). The study lists 4 primary outcomes in all. 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 30 Apr 2024.