Study of ALTO-300 in MDD
- Conditions
- Major Depressive Disorder
- Interventions
- Drug: ALTO-300Drug: Placebo
- Registration Number
- NCT05922878
- Lead Sponsor
- Alto Neuroscience
- Brief Summary
The purpose of this study is to determine efficacy differences between ALTO-300 and placebo, used adjunctively to an antidepressant, related to patient characteristics.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 200
- Have a diagnosis of moderate to severe major depressive disorder (MDD)
- At Visit 2, currently taking a single SSRI, SNRI, 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
- Nightly use of sleep medication
- Diagnosed bipolar disorder, psychotic disorder, or dementia
- Current moderate or severe substance use disorder
- Has a history of hypersensitivity or allergic reaction to ALTO-300 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-300 ALTO-300 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 Participants will receive matching placebo capsule once daily in the evening, from Day 1 to Day 42 in double blind (DB) treatment period.
- Primary Outcome Measures
Name Time Method To assess efficacy of adjunctive ALTO-300 versus placebo on symptoms of MDD in a pre-defined subgroup of participants as measured by the change over time up to week 6 in the Montgomery-Åsberg Depression Rating Scale (MADRS). Change over time for up 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 adjunctive ALTO-300 versus placebo on symptoms of MDD in all randomized participants as measured by the change over time up to week 6 in the Montgomery-Åsberg Depression Rating Scale (MADRS) Change over time for up 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 adjunctive ALTO-300 versus placebo for MDD as measured by the change over time up to week 6 in response (>50% improvement from baseline) rates based on the MADRS Change over time for up 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-300 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 14 Incidence, severity, and relatedness of Adverse Events
To evaluate the safety of ALTO-300 during both the OL and DB periods of the study as measured by the assessment of Heart Rate. Assessed from Day 1 to Week 14 Assessment of Heart Rate
To evaluate the safety of ALTO-300 during both the OL and DB periods of the study as measured by the assessment of Weight. Assessed from Day 1 to Week 14 Assessment of Weight
To evaluate the safety of ALTO-300 during both the OL and DB periods of the study as measured by the assessment of Blood Pressure. Assessed from Day 1 to Week 14 Assessment of Blood Pressure
To evaluate the safety of ALTO-300 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 15 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 (44)
Site 220
🇺🇸West Palm Beach, Florida, United States
Site 119
🇺🇸Boise, Idaho, United States
Site 344
🇺🇸Las Vegas, Nevada, United States
Site 200
🇺🇸Phoenix, Arizona, United States
Site 189
🇺🇸Phoenix, Arizona, United States
Site 209
🇺🇸Los Angeles, California, United States
Site 201
🇺🇸Marrero, Louisiana, United States
Site 214
🇺🇸Norwalk, Connecticut, United States
Site 219
🇺🇸Mather, California, United States
Site 218
🇺🇸Bellflower, California, United States
Site 187
🇺🇸Yuma, Arizona, United States
Site 224
🇺🇸Savannah, Georgia, United States
Site 194
🇺🇸Mission Viejo, California, United States
Site 203
🇺🇸Colorado Springs, Colorado, United States
Site 190
🇺🇸Miami Lakes, Florida, United States
Site 159
🇺🇸Clermont, Florida, United States
Site 215
🇺🇸Jackson, Mississippi, United States
Site 349
🇺🇸Evergreen, Colorado, United States
Site 192
🇺🇸Staten Island, New York, United States
Site 352
🇺🇸Moosic, Pennsylvania, United States
Site 195
🇺🇸Oklahoma City, Oklahoma, United States
Site 353
🇺🇸Plano, Texas, United States
Site 202
🇺🇸Cincinnati, Ohio, United States
Site 206
🇺🇸Missouri City, Texas, United States
Site 148
🇺🇸Fort Worth, Texas, United States
Site 216
🇺🇸Allentown, Pennsylvania, United States
Site 347
🇺🇸Fort Worth, Texas, United States
Site 211
🇺🇸Roanoke, Virginia, United States
Site 197
🇺🇸Temecula, California, United States
Site 161
🇺🇸Okeechobee, Florida, United States
Site 221
🇺🇸Tampa, Florida, United States
Site 335
🇺🇸Lafayette, California, United States
Site 193
🇺🇸Rogers, Arkansas, United States
Site 225
🇺🇸Miami Gardens, Florida, United States
Site 114
🇺🇸Albuquerque, New Mexico, United States
Site 198
🇺🇸Monroe, Louisiana, United States
Site 102
🇺🇸Dallas, Texas, United States
Site 199
🇺🇸Hickory, North Carolina, United States
Site 350
🇺🇸Media, Pennsylvania, United States
Site 196
🇺🇸Richmond, Texas, United States
Site 207
🇺🇸Clinton, Utah, United States
Site 191
🇺🇸Rochester, New York, United States
Site 217
🇺🇸Glendale, California, United States
Site 208
🇺🇸Snellville, Georgia, United States