Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ALTO-300 · 3 trials · 1 indication
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.
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.
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.
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.
Vital signs measured include blood pressure, heart rate, respiratory rate, temperature, and weight.
Blood samples for serum chemistry and hematology will be collected for clinical laboratory testing.
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.
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.
Incidence, severity, and relatedness of TEAEs,SAEs, discontinuation due to TEAEs, and deaths
| Arm | Type | Description |
|---|---|---|
| ALTO-300 | EXPERIMENTAL | Participants will receive ALTO-300 capsule once daily in the evening, from Day 1 to Day 42 in double blind (DB) treatment period. Eligible participants who will enter the open-label (OL) treatment period will receive ALTO-300 capsule once daily in the evening from OL baseline until the end of OL period/early termination visit (Up to 8 weeks). |
| Placebo | PLACEBO_COMPARATOR | Participants will receive matching placebo capsule once daily in the evening, from Day 1 to Day 42 in double blind (DB) treatment period. |
| Name | Type | Description |
|---|---|---|
| ALTO-300 | DRUG | ALTO-300 capsule QD |
| Placebo | DRUG | Placebo capsule QD |
| ALTO-300 PO Tablet | DRUG | One tablet daily |
| ALTO-300 oral (PO) tablet | DRUG | One tablet daily |
Inclusion Criteria: * Have a diagnosis of moderate to severe major depressive disorder (MDD) * At Visit 1, currently taking a single SSRI, SNRI, or bupropion for at least 6 weeks with no dose modifications in the past 2 weeks by Visit 2 * Willing to comply with all study assessments and procedures ...
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ALTO-300 is an investigational small molecule being developed for the treatment of Major Depressive Disorder (MDD). It is currently in Phase 2 clinical development and has not been approved by the FDA. The drug is being studied in adult patients aged 18 years and older in the United States.
ALTO-300 is being developed by Alto Neuroscience, Inc., a biopharmaceutical company traded on the stock exchange under the ticker symbol ANRO. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with Major Depressive Disorder.
ALTO-300 is currently in Phase 2 clinical development. It is an investigational drug and has not received FDA approval. The drug is being studied in multiple Phase 2 trials for Major Depressive Disorder, with one trial currently recruiting participants and two trials already completed.
ALTO-300 has been studied in three clinical trials for Major Depressive Disorder. Two trials, NCT05118750 and NCT05157945, have been completed, while one trial, NCT05922878, is currently recruiting. All trials are Phase 2, randomized, double-blind, and placebo-controlled, with a total enrollment of 560 participants.
No, ALTO-300 is not FDA approved. It is an investigational drug currently in Phase 2 clinical development for Major Depressive Disorder. The drug has not yet completed the clinical trials necessary to establish its safety and efficacy for regulatory approval.
ALTO-300 is a small molecule being developed for Major Depressive Disorder. Its specific molecular target has not been disclosed in the available information, so its mechanism of action is not fully described. The drug is being evaluated in clinical trials to determine its effectiveness in treating depression.