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The purpose of this study is to assess antidepressant efficacy differences between ALTO-100 and placebo during the Double-Blind period in patients with bipolar disorder I or II with current major depressive episode, when used adjunctively to a mood stabilizer and/or atypical antipsychotic, related to patient characteristics. Additionally, safety, tolerability, and efficacy will be assessed in a subsequent open label treatment period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ALTO-100 | Experimental | Participants will receive ALTO-100 40 mg tablet twice daily, from Day 1 to Week 6 in the double blind (DB) treatment period. Eligible participants who enter the open label (OL) treatment period will receive ALTO-100 40 mg 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 Week 6 in the double blind (DB) treatment period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALTO-100 | Drug | ALTO-100 40 mg tablet BID |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| To assess efficacy of ALTO-100 versus placebo on depression symptoms in bipolar disorder in a pre-defined subgroup of participants as measured by the mean 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 vs placebo for self-reported depressive symptoms in bipolar disorder patients in a pre- defined subgroup of participants 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. |
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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 |
| Name | Affiliation | Role |
|---|---|---|
| Adam Savitz, MD, PhD | Alto Neuroscience | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site 6036 | Withdrawn | Chandler | Arizona | 85224 | United States | |
| Site 6000 |
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| Drug |
Placebo tablet BID |
|
| Assessed 4 times over a 6-week interval, from Day 1 to Week 6 |
| To assess efficacy of ALTO-100 vs placebo in severity of bipolar disorder symptoms in a pre-defined subgroup of participants 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 depressive symptoms in MDD in a pre-defined subgroup as measured by the change from Day 1 to Week 6 in response (>50% improvement from baseline) and remission (total score of <10) rates based on 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 vs placebo on depressive symptoms in bipolar disorder in all randomized participants as measured by the change from Day 1 to Week 6 on the 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 evaluate the safety of ALTO-100 during both the DB and OL periods of the study as measured by the assessment of the incidence, severity, and relatedness of Treatment Emergent Adverse Events (TEAEs), SAEs, discontinuation due to TEAEs and deaths | Assessed from Day 1 to Week 13 |
| To evaluate the safety of ALTO-100 during both the DB and OL periods of the study as measured by the assessment of Heart Rate in bpm | Assessment of Heart Rate in bpm | Assessed from Day 1 to Week 13 |
| To evaluate the safety of ALTO-100 during both the DB and OL periods of the study as measured by the assessment of Blood Pressure in mmHg | Assessment of Blood Pressure in mmHg | Assessed from Day 1 to Week 13 |
| To evaluate the safety of ALTO-100 during both the DB and OL periods of the study as measured by the assessment of Weight in pounds | Assessment of Weight in pounds | Assessed from Day 1 to Week 13 |
| To evaluate the safety of ALTO-100 during both the DB and OL 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 0-4for 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 |
| Recruiting |
| Phoenix |
| Arizona |
| 85012 |
| United States |
| Site 6087 | Recruiting | Yuma | Arizona | 85364 | United States |
| 6039 | Recruiting | Fayetteville | Arkansas | 72703 | United States |
| 6070 | Recruiting | Little Rock | Arkansas | 72204 | United States |
| Site 6081 | Recruiting | Imperial | California | 92251 | United States |
| 6069 | Recruiting | Los Angeles | California | 90025 | United States |
| Site 6016 | Not yet recruiting | Mather | California | 95655 | United States |
| Site 6082 | Recruiting | Oceanside | California | 92056 | United States |
| Site 6102 | Recruiting | Riverside | California | 92506 | United States |
| Site 6112 | Not yet recruiting | Colorado Springs | Colorado | 80910 | United States |
| Site 6067 | Withdrawn | Lauderhill | Florida | 33319 | United States |
| Site 6068 | Recruiting | Atlanta | Georgia | 30328 | United States |
| Site 6064 | Recruiting | Peachtree Corners | Georgia | 30071 | United States |
| Site 6151 | Withdrawn | Baltimore | Maryland | 21229 | United States |
| Site 6076 | Recruiting | Bel Air | Maryland | 21015 | United States |
| Site 6062 | Recruiting | Gaithersburg | Maryland | 20877 | United States |
| Site 6142 | Recruiting | Lincoln | Nebraska | 68526 | United States |
| Site 6144 | Recruiting | Las Vegas | Nevada | 89102 | United States |
| Site 6104 | Recruiting | Las Vegas | Nevada | 89119 | United States |
| Site 6066 | Recruiting | Toms River | New Jersey | 08755 | United States |
| Site 6014 | Not yet recruiting | Albuquerque | New Mexico | 87108 | United States |
| Site 6078 | Recruiting | Albuquerque | New Mexico | 87110 | United States |
| 6065 | Recruiting | North Canton | Ohio | 44720 | United States |
| Site 6075 | Recruiting | Westlake | Ohio | 44145 | United States |
| Site 6072 | Recruiting | Houston | Texas | 77081 | United States |
| Site 6121 | Not yet recruiting | Draper | Utah | 84020 | United States |