Major Depressive DisorderPhase 2NCT05419869
Pilot Decentralized Trial
A Phase 2 study testing ALTO-100 PO Tablet in people with Major Depressive Disorder, run by Alto Neuroscience at 2 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-100. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- ALTO-100 PO Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jun 2022to 26 Jan 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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Have a diagnosis of moderate to severe major depressive disorder
- Either currently taking a SSRI, SNRI, mirtazapine, or bupropion for at least 6 weeks with no dose modifications in the past 2 weeks, or are not taking an antidepressant medication
- Willing to comply with all study assessments and procedures
- Must not be pregnant or breastfeeding at time of enrollment or throughout study
- Must have access with privacy to a computer with a keyboard and internet
Who cannot join
- Evidence of acute or unstable cardiovascular, respiratory, hepatic, or other major disease
- Active suicidal ideation
- Severe impediment to vision, hearing, and/or hand movement
- Diagnosed bipolar disorder or psychotic 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
2 sites in 1 country.
United States2 sites
Site 160
Coral Gables, Florida, 33134
Site 156
Jackson, Mississippi, 39216
About this study
Official title: An Open-Label Study of ALTO-100 in Adults With Major Depressive Disorder (MDD)
The purpose of this study is to collect biologically-based data for defining predictors and correlates of the effects of ALTO-100.
- Conditions
- Major Depressive Disorder
- Being tested
- ALTO-100 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-100 PO TabletDrug
Two tablets daily
| Study group | Role | What they receive |
|---|---|---|
| ALTO-100 | Experimental | ALTO-100 tablet PO ; twice daily dosing 8 weeks Receives: Drug: ALTO-100 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 score change in the Montgomery-Asberg Depression Rating Scale (MADRS) with ALTO-100 from start of dosing to end of treatment
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 score change from the start of dosing (Day 1) to the end of treatment (Day 56) is the primary outcome.
Measured: Measured at Day 1, Day 14, Day 28, Day 42, Day 56
To understand the relationship between baseline biology and score change in the Clinical Global Impression scale - Severity (CGI-S) with ALTO-100 from Screening to end of treatment
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 score change from Screening (Day [-21]) to the end of treatment (Day 56) is the primary outcome.
Measured: Measured at Screening, Day 1, Day 14, Day 28, Day 42, Day 56
Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability of ALTO-100
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
Measured: From the signing of the ICF until the follow-up visit (up to 13 weeks)
Number of Participants With Clinically Significant Laboratory Abnormalities as a Measure of Safety and Tolerability of ALTO-100
Blood samples for serum chemistry and hematology will be collected for clinical laboratory testing.
Measured: From the signing of the ICF until the end-of-treatment visit (up to 13 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2022
- Study start1 Jun 2022
- Primary completion13 Jan 2023
- Study completion26 Jan 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
- 21 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
- NCT05419869
- Sponsor's protocol ID
- ALTO-100-003
- Status last verified
- Jan 2024
- First submitted
- 16 May 2022
- Last updated
- 18 Jan 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 18 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Study of ALTO-100 in Adults With Major Depressive Disorder (MDD)
- ClinicalTrials.gov ID
- NCT05419869
- Acronym / sponsor ID
- ALTO-100-003
- Conditions
- Major Depressive Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Alto NeuroscienceIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 13 Jan 2023 (actual)
- Study completion
- 26 Jan 2023 (actual)
- First posted
- 15 Jun 2022 (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-100.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ALTO-100 | Experimental | Drug: ALTO-100 PO TabletALTO-100 tablet PO ; twice daily dosing 8 weeks |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Have a diagnosis of moderate to severe major depressive disorder
- Either currently taking a SSRI, SNRI, mirtazapine, or bupropion for at least 6 weeks with no dose modifications in the past 2 weeks, or are not taking an antidepressant medication
- Willing to comply with all study assessments and procedures
- Must not be pregnant or breastfeeding at time of enrollment or throughout study
- Must have access with privacy to a computer with a keyboard and internet
Key exclusion criteria (6 listed)
- Evidence of acute or unstable cardiovascular, respiratory, hepatic, or other major disease
- Active suicidal ideation
- Severe impediment to vision, hearing, and/or hand movement
- Diagnosed bipolar disorder or psychotic disorder
- Has a history of hypersensitivity or allergic reaction to ALTO-100 or any of its components/excipients
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-100 PO TabletTwo tablets daily | Drug | ALTO-100 |
Primary outcome
To understand the relationship between baseline biology and score change in the Montgomery-Asberg Depression Rating Scale (MADRS) with ALTO-100 from start of dosing to end of treatment
Time frame: Measured at Day 1, Day 14, Day 28, Day 42, Day 56
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 score change from the start of dosing (Day 1) to the end of treatment (Day 56) is the primary outcome.
To understand the relationship between baseline biology and score change in the Clinical Global Impression scale - Severity (CGI-S) with ALTO-100 from Screening to end of treatment
Time frame: Measured at Screening, Day 1, Day 14, Day 28, Day 42, Day 56
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 score change from Screening (Day [-21]) to the end of treatment (Day 56) is the primary outcome.
Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability of ALTO-100
Time frame: From the signing of the ICF until the follow-up visit (up to 13 weeks)
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
Number of Participants With Clinically Significant Laboratory Abnormalities as a Measure of Safety and Tolerability of ALTO-100
Time frame: From the signing of the ICF until the end-of-treatment visit (up to 13 weeks)
Blood samples for serum chemistry and hematology will be collected for clinical laboratory testing.
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 18 Jan 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.
2 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-100 PO Tablet in people with Major Depressive Disorder, run by Alto Neuroscience at 2 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 5 inclusion and 6 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 18 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 score change in the Montgomery-Asberg Depression Rating Scale (MADRS) with ALTO-100 from start of dosing to end of treatment (time frame: Measured at Day 1, Day 14, Day 28, Day 42, Day 56). 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 18 Jan 2024.