Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to determine efficacy differences between ALTO-100 and placebo, used either as monotherapy or adjunctively to an antidepressant, related to patient characteristics.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ALTO-100 | Experimental | Participants will receive ALTO-100 tablet twice daily, 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-100 tablet twice daily from OL baseline until the end of OL period/early termination visit (Up to 7 weeks). |
|
| Placebo DB | Placebo Comparator | Participants will receive matching placebo tablet twice daily, from Day 1 to Day 42 in double blind (DB) treatment period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALTO-100 | Drug | ALTO-100 tablet BID |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| To assess efficacy of ALTO-100 versus placebo on symptoms of MDD in a pre-defined subgroup of participants as measured by the change from Day 1 to Week 6 on the Montgomery-Åsberg Depression Rating Scale (MADRS) total score. | 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 assessed from Day 1 to Week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| To assess efficacy of ALTO-100 versus placebo for symptoms of MDD in a pre-defined subgroup of participants who are taking ALTO-100 as monotherapy for MDD as measured by the change from Day 1 to Week 6 on the MADRS total score. | 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Adam Savitz, MD, PhD | Alto Neuroscience | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site 174 | Birmingham | Alabama | 35294 | United States | ||
| Site 173 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
Placebo tablet BID |
|
| Change assessed from Day 1 to Week 6 |
| To assess efficacy of ALTO-100 versus placebo on symptoms of MDD in all randomized participants as measured by the change from Day 1 to Week 6 on the Montgomery-Åsberg Depression Rating Scale (MADRS) | 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. | Assessed 4 times over a 6 week interval, from Day 1 to Week 6 |
| To assess efficacy of ALTO-100 versus placebo for MDD as measured by the change from Day 1 to Week 6 in Clinician Global Impression Scale-severity (CGI-S). | The 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. | Assessed 4 times over a 6 week interval, from Day 1 to Week 6 |
| To assess efficacy of ALTO-100 vs placebo for MDD as measured by the change from Day 1 to Week 6 in response (>50% improvement from baseline) and remission (total MADRS score of <10) rates based on the Montgomery-Åsberg Depression Rating Scale (MADRS) | 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. | Assessed 4 times over a 6- week interval, from Day 1 to Week 6 |
| To assess efficacy of ALTO-100 versus placebo for MDD as measured by the change from Day 1 to Week 6 in Patient Health Questionnaire, 9 item (PHQ-9). | The PHQ-9 is a 9-item, participant reported outcome measure to assess depressive symptoms. The scale scores each of the 9 symptom domains of the diagnostic and statistical manual of mental disorders-5th edition (DSM-5) major depressive disorder (MDD) criteria. Each item is rated on a 4- point scale (0=not at all, 1=several days, 2=more than half the days, and 3=nearly every day). The participant's item responses are summed to provide a total score (range of 0 to 27), with higher scores indicating greater severity of depressive symptoms. | Assessed 4 times over a 6- week interval, from Day 1 to Week 6 |
| To evaluate the safety of ALTO-100 during both the OL and DB periods of the study as measured by the assessment of the incidence, severity, and relatedness of Adverse Events. | Incidence, severity, and relatedness of Adverse Events. | Assessed from Day 1 to Week 13 |
| To evaluate the safety of ALTO-100 during both the OL and DB periods of the study as measured by the assessment of Heart Rate. | Assessment of Heart Rate. | Assessed from Day 1 to Week 13 |
| To evaluate the safety of ALTO-100 during both the OL and DB periods of the study as measured by the assessment of Blood Pressure. | Assessment of Blood Pressure. | Assessed from Day 1 to Week 13 |
| To evaluate the safety of ALTO-100 during both the OL and DB periods of the study as measured by the assessment of Weight. | Assessment of Weight. | Assessed from Day 1 to Week 13 |
| To evaluate the safety of ALTO-100 during both the OL and DB periods of the study as measured by the assessment of suicidality with the Concise Health Risk Tracking Self-Report,12 item scale (CHRT-SR12). | The CHRT is a brief, self-report measure that systematically assesses both suicidal thinking and associated thoughts that may indicate the propensity for suicidal acts. The CHRT-SR12 is a 12 item scale. The patient assigns a score of 0-4 for each item of the scale, allowing for a total score of 0 to 48, with the higher score signifying more severe symptoms. | Assessed from Day 1 to Week 13 |
| Huntsville |
| Alabama |
| 35801 |
| United States |
| Site 136 | Chandler | Arizona | 85226 | United States |
| Site 139 | Little Rock | Arkansas | 72211 | United States |
| Site 141 | Costa Mesa | California | 92626 | United States |
| Site 118 | Fresno | California | 93703 | United States |
| Site 181 | Imperial | California | 92251 | United States |
| Site 182 | Oceanside | California | 92056 | United States |
| Site 188 | Oceanside | California | 92056 | United States |
| Site 179 | Rancho Cucamonga | California | 91730 | United States |
| Site 116 | Sacramento | California | 95655 | United States |
| Site 185 | Centennial | Colorado | 80112 | United States |
| Site 186 | Brooksville | Florida | 34613 | United States |
| Site 204 | Jacksonville | Florida | 32256 | United States |
| Site 205 | Orlando | Florida | 32801 | United States |
| Site 212 | Tampa | Florida | 33629 | United States |
| Site 213 | Tampa | Florida | 33629 | United States |
| Site 137 | Carmel | Indiana | 46032 | United States |
| Site 151 | Baltimore | Maryland | 21229 | United States |
| Site 108 | Jackson | Mississippi | 39216 | United States |
| Site 171 | Jackson | Mississippi | 39216 | United States |
| Site 142 | Lincoln | Nebraska | 68562 | United States |
| Site 144 | Las Vegas | Nevada | 89102 | United States |
| Site 178 | Albuquerque | New Mexico | 87109 | United States |
| Site 184 | Brooklyn | New York | 11229 | United States |
| Site 180 | New York | New York | 10022 | United States |
| Site 210 | New York | New York | 10128 | United States |
| Site 175 | Westlake | Ohio | 44145 | United States |
| Site 157 | North Charleston | South Carolina | 29405 | United States |
| Site 183 | Memphis | Tennessee | 38119 | United States |
| Site 147 | Fort Worth | Texas | 76104 | United States |
| Site 120 | Houston | Texas | 77054 | United States |
| Site 172 | Houston | Texas | 77081 | United States |
| Site 121 | Draper | Utah | 84020 | United States |
| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided