What this study is
The purpose of this study is to determine efficacy differences between ALTO-300 and placebo, used adjunctively to an antidepressant, related to patient characteristics.
What's being tested
- ALTO-300
Intervention · DRUG
ALTO-300 capsule QD
- Placebo
Intervention · DRUG
Placebo capsule QD
Study details
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Study of ALTO-300 With an Open-Label Extension in Adults With Major Depressive Disorder
- Sponsor
- Alto Neuroscience
- Conditions
- Major Depressive Disorder
- Enrolling
- 325 people
- Starts
- 2023-06-08
- Est. completion
- 2026-12
- Design
- Quadruple-blind, randomized, parallel groups, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 70 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- Have a diagnosis of moderate to severe major depressive disorder (MDD)
- At Visit 1, currently taking a stable dose of 1 or 2 antidepressants (e.g., SSRI, SNRI, bupropion, or gepirone) for at least 6 weeks with no dose modifications in the past 2 weeks by Visit 2
- Willing to comply with all study assessments and procedures
- Must not be pregnant or breastfeeding at time of enrollment or throughout study
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (75)
31 openSite 200
Phoenix, Arizona, United States
RecruitingSite 193
Rogers, Arkansas, United States
RecruitingSite 218
Bellflower, California, United States
RecruitingSite 335
Lafayette, California, United States
RecruitingSite 335
Lafayette, California, United States
RecruitingSite 219
Mather, California, United States
RecruitingSite 267
Moorpark, California, United States
RecruitingSite 197
Temecula, California, United States
RecruitingSite 343
Denver, Colorado, United States
RecruitingSite 221
Tampa, Florida, United States
RecruitingSite 238
Fayetteville, Georgia, United States
RecruitingSite 293
Stone Mountain, Georgia, United States
Not yet recruitingSite 236
Boise, Idaho, United States
RecruitingSite 288
Worcester, Massachusetts, United States
RecruitingSite 240
Mankato, Minnesota, United States
RecruitingSite 265
Minneapolis, Minnesota, United States
RecruitingSite 264
St Louis, Missouri, United States
RecruitingSite 344
Las Vegas, Nevada, United States
RecruitingSite 114
Albuquerque, New Mexico, United States
RecruitingSite 283
New York, New York, United States
RecruitingSite 287
Rose Hill, North Carolina, United States
RecruitingSite 268
Winston-Salem, North Carolina, United States
RecruitingSite 202
Cincinnati, Ohio, United States
RecruitingSite 316
Austin, Texas, United States
RecruitingSite 239
Conroe, Texas, United States
RecruitingSite 275
Houston, Texas, United States
RecruitingSite 320
Houston, Texas, United States
RecruitingSite 353
Plano, Texas, United States
RecruitingSite 234
San Marcos, Texas, United States
RecruitingSite 235
Stephenville, Texas, United States
RecruitingSite 277
Fairfax, Virginia, United States
RecruitingSite 189
Phoenix, Arizona, United States
WithdrawnSite 187
Yuma, Arizona, United States
Active, not recruitingSite 318
Carlsbad, California, United States
Active, not recruitingSite 217
Glendale, California, United States
Active, not recruitingSite 209
Los Angeles, California, United States
Active, not recruitingSite 194
Mission Viejo, California, United States
TerminatedSite 203
Colorado Springs, Colorado, United States
Active, not recruitingSite 345
Evergreen, Colorado, United States
Active, not recruitingSite 349
Evergreen, Colorado, United States
Active, not recruitingSite 214
Norwalk, Connecticut, United States
WithdrawnSite 159
Clermont, Florida, United States
TerminatedSite 225
Miami Gardens, Florida, United States
Active, not recruitingSite 190
Miami Lakes, Florida, United States
Active, not recruitingSite 161
Okeechobee, Florida, United States
Active, not recruitingSite 220
West Palm Beach, Florida, United States
Active, not recruitingSite 224
Savannah, Georgia, United States
Active, not recruitingSite 208
Snellville, Georgia, United States
TerminatedSite 317
Blackfoot, Idaho, United States
WithdrawnSite 119
Boise, Idaho, United States
Active, not recruitingSite 310
Chicago, Illinois, United States
Active, not recruitingSite 314
Wichita, Kansas, United States
Active, not recruitingSite 201
Marrero, Louisiana, United States
TerminatedSite 198
Monroe, Louisiana, United States
TerminatedSite 279
Hattiesburg, Mississippi, United States
WithdrawnSite 215
Jackson, Mississippi, United States
Active, not recruitingSite 229
Creve Couer, Missouri, United States
WithdrawnSite 231
Omaha, Nebraska, United States
Active, not recruitingSite 319
New York, New York, United States
Active, not recruitingSite 191
Rochester, New York, United States
TerminatedSite 192
Staten Island, New York, United States
TerminatedSite 199
Hickory, North Carolina, United States
Active, not recruitingSite 195
Oklahoma City, Oklahoma, United States
TerminatedSite 303
Oklahoma City, Oklahoma, United States
WithdrawnSite 216
Allentown, Pennsylvania, United States
TerminatedSite 350
Media, Pennsylvania, United States
WithdrawnSite 352
Moosic, Pennsylvania, United States
Active, not recruitingSite 102
Dallas, Texas, United States
Active, not recruitingSite 347
Fort Worth, Texas, United States
TerminatedSite 148
Fort Worth, Texas, United States
WithdrawnSite 206
Missouri City, Texas, United States
WithdrawnSite 196
Richmond, Texas, United States
TerminatedSite 207
Clinton, Utah, United States
Active, not recruitingSite 315
Provo, Utah, United States
Active, not recruitingSite 211
Roanoke, Virginia, United States
Active, not recruiting
Study team
Sponsor
Alto Neuroscience
Study ID ALTO-300-201
Study director
Adam Savitz, MD, PhD
Alto Neuroscience
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.