Phase 2b Study of ALTO-100 in MDD
- Conditions
- Major Depressive Disorder
- Interventions
- Drug: Placebo
- Registration Number
- NCT05712187
- Lead Sponsor
- Alto Neuroscience
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 301
- Have a diagnosis of moderate to severe major depressive disorder (MDD)
- At baseline, either not taking an antidepressant medication, or currently taking a single SSRI, SNRI, mirtazapine, or bupropion for at least 6 weeks with no dose modifications in the past 2 weeks
- Willing to comply with all study assessments and procedures
- Must not be pregnant or breastfeeding at time of enrollment or throughout study
- Evidence of unstable medical condition
- Diagnosed bipolar disorder, psychotic disorder, or dementia
- Current moderate or severe substance use 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ALTO-100 ALTO-100 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 Participants will receive matching placebo tablet twice daily, from Day 1 to Day 42 in double blind (DB) treatment period.
- Primary Outcome Measures
Name Time Method 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. Change assessed from Day 1 to Week 6 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.
- Secondary Outcome Measures
Name Time Method 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). Assessed 4 times over a 6 week interval, from Day 1 to Week 6 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.
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. Assessed from Day 1 to Week 13 Assessment of Blood Pressure.
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. Change assessed from Day 1 to Week 6 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.
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. Assessed from Day 1 to Week 13 Incidence, severity, and relatedness of Adverse Events.
To evaluate the safety of ALTO-100 during both the OL and DB periods of the study as measured by the assessment of Weight. Assessed from Day 1 to Week 13 Assessment of Weight.
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) Assessed 4 times over a 6 week interval, from Day 1 to Week 6 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.
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. Assessed from Day 1 to Week 13 Assessment of Heart Rate.
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) Assessed 4 times over a 6- week interval, from Day 1 to Week 6 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.
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). Assessed 4 times over a 6- week interval, from Day 1 to Week 6 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.
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). Assessed from Day 1 to Week 13 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.
Trial Locations
- Locations (34)
Site 173
🇺🇸Huntsville, Alabama, United States
Site 118
🇺🇸Fresno, California, United States
Site 179
🇺🇸Rancho Cucamonga, California, United States
Site 108
🇺🇸Jackson, Mississippi, United States
Site 141
🇺🇸Costa Mesa, California, United States
Site 181
🇺🇸Imperial, California, United States
Site 137
🇺🇸Carmel, Indiana, United States
Site 120
🇺🇸Houston, Texas, United States
Site 172
🇺🇸Houston, Texas, United States
Site 180
🇺🇸New York, New York, United States
Site 175
🇺🇸Westlake, Ohio, United States
Site 210
🇺🇸New York, New York, United States
Site 184
🇺🇸Brooklyn, New York, United States
Site 157
🇺🇸North Charleston, South Carolina, United States
Site 144
🇺🇸Las Vegas, Nevada, United States
Site 174
🇺🇸Birmingham, Alabama, United States
Site 212
🇺🇸Tampa, Florida, United States
Site 213
🇺🇸Tampa, Florida, United States
Site 136
🇺🇸Chandler, Arizona, United States
Site 139
🇺🇸Little Rock, Arkansas, United States
Site 182
🇺🇸Oceanside, California, United States
Site 188
🇺🇸Oceanside, California, United States
Site 185
🇺🇸Centennial, Colorado, United States
Site 186
🇺🇸Brooksville, Florida, United States
Site 204
🇺🇸Jacksonville, Florida, United States
Site 151
🇺🇸Baltimore, Maryland, United States
Site 171
🇺🇸Jackson, Mississippi, United States
Site 142
🇺🇸Lincoln, Nebraska, United States
Site 178
🇺🇸Albuquerque, New Mexico, United States
Site 183
🇺🇸Memphis, Tennessee, United States
Site 147
🇺🇸Fort Worth, Texas, United States
Site 121
🇺🇸Draper, Utah, United States
Site 116
🇺🇸Sacramento, California, United States
Site 205
🇺🇸Orlando, Florida, United States