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The purpose of this trial is to measure depressive symptoms following treatment with ALTO-207 compared with placebo in participants with TRD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ALTO-207 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALTO-207 | Drug | ALTO-207 BID |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Change from baseline up to 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alto Neuroscience | Contact | 650-200-0412 | clinical@altoneuroscience.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site 7074 | Not yet recruiting | Birmingham | Alabama | 35294 | United States | |
| Site 7173 |
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| Drug |
Matching Placebo |
|
| 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. | Change from baseline up to 8 weeks |
| Not yet recruiting |
| Dothan |
| Alabama |
| 36345 |
| United States |
| Site 7000 | Recruiting | Phoenix | Arizona | 85012 | United States |
| Site 7153 | Not yet recruiting | Chino | California | 91710 | United States |
| Site 7156 | Not yet recruiting | Oakland | California | 94610 | United States |
| Site 7082 | Recruiting | Oceanside | California | 92056 | United States |
| Site 7159 | Not yet recruiting | Palo Alto | California | 94304 | United States |
| Site 7016 | Not yet recruiting | Sacramento | California | 95655 | United States |
| Site 7144 | Recruiting | San Diego | California | 92123 | United States |
| Site 7171 | Not yet recruiting | Valley Village | California | 91607 | United States |
| Site 7152 | Recruiting | Saint Augustine | Florida | 32086 | United States |
| Site 7148 | Recruiting | Albany | Georgia | 31707 | United States |
| Site 7146 | Not yet recruiting | Atlanta | Georgia | 30060 | United States |
| Site 7064 | Not yet recruiting | Peachtree Corners | Georgia | 30078 | United States |
| Site 7141 | Recruiting | Savannah | Georgia | 31406 | United States |
| Site 7169 | Not yet recruiting | Indianapolis | Indiana | 46202 | United States |
| Site 7151 | Recruiting | Annapolis | Maryland | 21401 | United States |
| Site 7054 | Not yet recruiting | Pikesville | Maryland | 21208 | United States |
| Site 7166 | Not yet recruiting | Worcester | Massachusetts | 01606 | United States |
| Site 7155 | Not yet recruiting | Ann Arbor | Michigan | 48109 | United States |
| Site 7154 | Recruiting | Bloomfield Hills | Michigan | 48302 | United States |
| Site 7170 | Not yet recruiting | Amherst | New York | 14226 | United States |
| Site 7055 | Not yet recruiting | Cedarhurst | New York | 11516 | United States |
| Site 7162 | Not yet recruiting | Lewiston | New York | 14214 | United States |
| Site 7157 | Not yet recruiting | Syracuse | New York | 13210 | United States |
| Site 7143 | Recruiting | Charlotte | North Carolina | 28287 | United States |
| Site 7029 | Recruiting | Cincinnati | Ohio | 45215 | United States |
| Site 7158 | Not yet recruiting | Garfield Heights | Ohio | 44125 | United States |
| Site 7172 | Not yet recruiting | East Providence | Rhode Island | 02914 | United States |
| Site 7176 | Not yet recruiting | Dallas | Texas | 75243 | United States |
| Site 7160 | Not yet recruiting | Fort Worth | Texas | 76104 | United States |
| Site 7150 | Not yet recruiting | Galveston | Texas | 77555 | United States |
| Site 7175 | Not yet recruiting | Houston | Texas | 77007 | United States |
| Site 7145 | Recruiting | Houston | Texas | 77030 | United States |
| Site 7161 | Recruiting | Irving | Texas | 75062 | United States |
| Site 7177 | Not yet recruiting | Fairfax | Virginia | 22030 | United States |
| Site 7128 | Not yet recruiting | Seattle | Washington | 98004 | United States |
| Site 7163 | Not yet recruiting | South Charleston | West Virginia | 25303 | United States |
| Site 7419 | Not yet recruiting | Antrim | United Kingdom |
| Site 7411 | Not yet recruiting | Birmingham | United Kingdom |
| Site 7414 | Not yet recruiting | Bristol | United Kingdom |
| Site 7412 | Not yet recruiting | Cardiff | United Kingdom |
| Site 7418 | Not yet recruiting | Exeter | United Kingdom |
| Site 7415 | Not yet recruiting | London | United Kingdom |
| Site 7413 | Not yet recruiting | Nottingham | United Kingdom |
| Site 7410 | Not yet recruiting | Oxford | United Kingdom |
| Site 7402 | Not yet recruiting | Prescot | United Kingdom |
| Site 7416 | Not yet recruiting | Sheffield | United Kingdom |
| ID | Term |
|---|---|
| D061218 | Depressive Disorder, Treatment-Resistant |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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