Clinical trial NCT05117632: ALTO-100 in MDD and/or PTSD
Official title: An Open-label Study of ALTO-100 in Adults With Major Depressive Disorder and/or Post-traumatic Stress Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Major Depressive Disorder
Post Traumatic Stress Disorder
Lead sponsor: Alto Neuroscience
Sponsor class: INDUSTRY
First posted: 2021-11-11
Enrollment: 245
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of this study is to collect biologically based data for defining predictors and correlates of the effects of ALTO-100.


Eligibility criteria: Inclusion Criteria:

* Have a diagnosis of moderate to severe major depressive disorder (MDD) and/or post-traumatic stress disorder (PTSD)
* At baseline, either not taking an antidepressant medication, or currently taking a 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 cardiovascular, respiratory, liver, or renal impairment or disease
* Active suicidal ideation
* 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 understand the relationship between baseline biology and clinical outcome with ALTO-100 using the Montgomery-Åsberg Depression Rating Scale (MADRS)
timeFrame: Measured 5 times over 8 weeks
measure: To understand the relationship between baseline biology and clinical outcome with ALTO-100 using the Clinical Global Impression scale - Severity (CGI-S)
timeFrame: Measured 5 times over 8 weeks
measure: To understand the relationship between baseline biology and clinical outcome with ALTO-100 using the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
timeFrame: Measured 3 times over 8 weeks
measure: Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability of ALTO-100
timeFrame: From the signing of the ICF until the follow-up visit (up to 12 weeks)
measure: Number of Participants With Clinically Significant Vital Signs Abnormalities as a Measure of Safety and Tolerability of ALTO-100
timeFrame: From the signing of the ICF until the end-of-treatment visit (up to 11 weeks)
measure: Number of Participants With Clinically Significant Laboratory Abnormalities as a Measure of Safety and Tolerability of ALTO-100
timeFrame: From the signing of the ICF until the end-of-treatment visit (up to 11 weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: Tempe
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: Martinez
country: United States
facility: Site 116
state: California
city: Mather
country: United States
facility: Site 116
state: California
city: Boca Raton
country: United States
facility: Site 150
state: Florida
city: Doral
country: United States
facility: Site 112
state: Florida
city: Elgin
country: United States
facility: Site 155
state: Illinois
city: Noblesville
country: United States
facility: Site 137
state: Indiana
city: Baltimore
country: United States
facility: Site 151
state: Maryland
city: Belmont
country: United States
facility: Site 109
state: Massachusetts
city: Jackson
country: United States
facility: Site 108
state: Mississippi
city: Lincoln
country: United States
facility: Site 142
state: Nebraska
city: Las Vegas
country: United States
facility: Site 144
state: Nevada
city: Middleburg Heights
country: United States
facility: Site 146
state: Ohio
city: Fort Worth
country: United States
facility: Site 147
state: Texas
city: Fort Worth
country: United States
facility: Site 148
state: Texas
city: Houston
country: United States
facility: Site 120
state: Texas
city: Houston
country: United States
facility: Site 113
state: Texas
city: Draper
country: United States
facility: Site 121
state: Utah
city: Seattle
country: United States
facility: Site 105
state: Washington
city: Tacoma
country: United States
facility: NTC Seattle (105a)
state: Washington
Study officials:
References: