Clinical trial NCT05712187: Phase 2b Study of ALTO-100 in MDD
Official title: A Randomized, Double-Blind, Placebo-Controlled Study of ALTO-100 With an Open-Label Extension in Adults With Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Major Depressive Disorder
Lead sponsor: Alto Neuroscience
Sponsor class: INDUSTRY
First posted: 2023-02-03
Enrollment: 301
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: 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-100 and placebo, used either as monotherapy or adjunctively to an antidepressant, related to patient characteristics.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: 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.
timeFrame: Change assessed from Day 1 to Week 6
Secondary outcomes:
measure: 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.
timeFrame: Change assessed from Day 1 to Week 6
measure: 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)
timeFrame: Assessed 4 times over a 6 week interval, from Day 1 to Week 6
measure: 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).
timeFrame: Assessed 4 times over a 6 week interval, from Day 1 to Week 6
measure: 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)
timeFrame: Assessed 4 times over a 6- week interval, from Day 1 to Week 6
measure: 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).
timeFrame: Assessed 4 times over a 6- week interval, from Day 1 to Week 6
measure: 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.
timeFrame: Assessed from Day 1 to Week 13
measure: 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.
timeFrame: Assessed from Day 1 to Week 13
measure: 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.
timeFrame: Assessed from Day 1 to Week 13
measure: To evaluate the safety of ALTO-100 during both the OL and DB periods of the study as measured by the assessment of Weight.
timeFrame: Assessed from Day 1 to Week 13
measure: 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).
timeFrame: Assessed from Day 1 to Week 13
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Site 174
state: Alabama
city: Huntsville
country: United States
facility: Site 173
state: Alabama
city: Chandler
country: United States
facility: Site 136
state: Arizona
city: Little Rock
country: United States
facility: Site 139
state: Arkansas
city: Costa Mesa
country: United States
facility: Site 141
state: California
city: Fresno
country: United States
facility: Site 118
state: California
city: Imperial
country: United States
facility: Site 181
state: California
city: Oceanside
country: United States
facility: Site 182
state: California
city: Oceanside
country: United States
facility: Site 188
state: California
city: Rancho Cucamonga
country: United States
facility: Site 179
state: California
city: Sacramento
country: United States
facility: Site 116
state: California
city: Centennial
country: United States
facility: Site 185
state: Colorado
city: Brooksville
country: United States
facility: Site 186
state: Florida
city: Jacksonville
country: United States
facility: Site 204
state: Florida
city: Orlando
country: United States
facility: Site 205
state: Florida
city: Tampa
country: United States
facility: Site 212
state: Florida
city: Tampa
country: United States
facility: Site 213
state: Florida
city: Carmel
country: United States
facility: Site 137
state: Indiana
city: Baltimore
country: United States
facility: Site 151
state: Maryland
city: Jackson
country: United States
facility: Site 108
state: Mississippi
city: Jackson
country: United States
facility: Site 171
state: Mississippi
city: Lincoln
country: United States
facility: Site 142
state: Nebraska
city: Las Vegas
country: United States
facility: Site 144
state: Nevada
city: Albuquerque
country: United States
facility: Site 178
state: New Mexico
city: Brooklyn
country: United States
facility: Site 184
state: New York
city: New York
country: United States
facility: Site 180
state: New York
city: New York
country: United States
facility: Site 210
state: New York
city: Westlake
country: United States
facility: Site 175
state: Ohio
city: North Charleston
country: United States
facility: Site 157
state: South Carolina
city: Memphis
country: United States
facility: Site 183
state: Tennessee
city: Fort Worth
country: United States
facility: Site 147
state: Texas
city: Houston
country: United States
facility: Site 120
state: Texas
city: Houston
country: United States
facility: Site 172
state: Texas
city: Draper
country: United States
facility: Site 121
state: Utah
Study officials:
affiliation: Alto Neuroscience
name: Adam Savitz, MD, PhD
role: STUDY_DIRECTOR
References: