Clinical trial NCT05922878: Study of ALTO-300 in MDD
Official title: A Randomized, Double-Blind, Placebo-Controlled Study of ALTO-300 With an Open-Label Extension in Adults With Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Major Depressive Disorder
Lead sponsor: Alto Neuroscience
Sponsor class: INDUSTRY
First posted: 2023-06-28
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: 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).
timeFrame: Change over time for up to week 6
Secondary outcomes:
measure: 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)
timeFrame: Change over time for up to week 6
measure: 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
timeFrame: Change over time for up to week 6
measure: 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.
timeFrame: Assessed from Day 1 to Week 14
measure: 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.
timeFrame: Assessed from Day 1 to Week 14
measure: To evaluate the safety of ALTO-300 during both the OL and DB periods of the study as measured by the assessment of Weight.
timeFrame: Assessed from Day 1 to Week 14
measure: 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.
timeFrame: Assessed from Day 1 to Week 14
measure: 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).
timeFrame: Assessed from Day 1 to Week 15
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Site 200
state: Arizona
city: Phoenix
country: United States
facility: Site 189
state: Arizona
city: Yuma
country: United States
facility: Site 187
state: Arizona
city: Rogers
country: United States
facility: Site 193
state: Arkansas
city: Bellflower
country: United States
facility: Site 218
state: California
city: Glendale
country: United States
facility: Site 217
state: California
city: Lafayette
country: United States
facility: Site 335
state: California
city: Los Angeles
country: United States
facility: Site 209
state: California
city: Mather
country: United States
facility: Site 219
state: California
city: Mission Viejo
country: United States
facility: Site 194
state: California
city: Temecula
country: United States
facility: Site 197
state: California
city: Colorado Springs
country: United States
facility: Site 203
state: Colorado
city: Evergreen
country: United States
facility: Site 349
state: Colorado
city: Norwalk
country: United States
facility: Site 214
state: Connecticut
city: Clermont
country: United States
facility: Site 159
state: Florida
city: Miami Gardens
country: United States
facility: Site 225
state: Florida
city: Miami Lakes
country: United States
facility: Site 190
state: Florida
city: Okeechobee
country: United States
facility: Site 161
state: Florida
city: Tampa
country: United States
facility: Site 221
state: Florida
city: West Palm Beach
country: United States
facility: Site 220
state: Florida
city: Savannah
country: United States
facility: Site 224
state: Georgia
city: Snellville
country: United States
facility: Site 208
state: Georgia
city: Boise
country: United States
facility: Site 119
state: Idaho
city: Marrero
country: United States
facility: Site 201
state: Louisiana
city: Monroe
country: United States
facility: Site 198
state: Louisiana
city: Jackson
country: United States
facility: Site 215
state: Mississippi
city: Las Vegas
country: United States
facility: Site 344
state: Nevada
city: Albuquerque
country: United States
facility: Site 114
state: New Mexico
city: Rochester
country: United States
facility: Site 191
state: New York
city: Staten Island
country: United States
facility: Site 192
state: New York
city: Hickory
country: United States
facility: Site 199
state: North Carolina
city: Cincinnati
country: United States
facility: Site 202
state: Ohio
city: Oklahoma City
country: United States
facility: Site 195
state: Oklahoma
city: Allentown
country: United States
facility: Site 216
state: Pennsylvania
city: Media
country: United States
facility: Site 350
state: Pennsylvania
city: Moosic
country: United States
facility: Site 352
state: Pennsylvania
city: Dallas
country: United States
facility: Site 102
state: Texas
city: Fort Worth
country: United States
facility: Site 347
state: Texas
city: Fort Worth
country: United States
facility: Site 148
state: Texas
city: Missouri City
country: United States
facility: Site 206
state: Texas
city: Plano
country: United States
facility: Site 353
state: Texas
city: Richmond
country: United States
facility: Site 196
state: Texas
city: Clinton
country: United States
facility: Site 207
state: Utah
city: Roanoke
country: United States
facility: Site 211
state: Virginia
Study officials:
affiliation: Alto Neuroscience
name: Adam Savitz, MD, PhD
role: STUDY_DIRECTOR
References: