Study of ALTO-300 in MDD

Major Depressive Disorder Clinical Trial

Official title:

A Randomized, Double-Blind, Placebo-Controlled Study of ALTO-300 With an Open-Label Extension in Adults With Major Depressive Disorder

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05922878
• Other study ID #: ALTO-300-201
• Status: Recruiting
• Phase: Phase 2
• Start date: June 8, 2023
• Est. completion date: May 2025

Study information

• Verified date: February 2024
• Source: Alto Neuroscience
• Contact: Alto Neuroscience
• Phone: 650-200-0412
• Email: clinical[@]altoneuroscience.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: May 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Drug:
• ALTO-300
ALTO-300 capsule QD
• Placebo
Placebo capsule QD

Locations

Country	Name	City	State
United States	Site 114	Albuquerque	New Mexico
United States	Site 216	Allentown	Pennsylvania
United States	Site 218	Bellflower	California
United States	Site 119	Boise	Idaho
United States	Site 202	Cincinnati	Ohio
United States	Site 159	Clermont	Florida
United States	Site 207	Clinton	Utah
United States	Site 203	Colorado Springs	Colorado
United States	Site 102	Dallas	Texas
United States	Site 148	Fort Worth	Texas
United States	Site 347	Fort Worth	Texas
United States	Site 217	Glendale	California
United States	Site 199	Hickory	North Carolina
United States	Site 215	Jackson	Mississippi
United States	Site 344	Las Vegas	Nevada
United States	Site 209	Los Angeles	California
United States	Site 201	Marrero	Louisiana
United States	Site 219	Mather	California
United States	Site 190	Miami Lakes	Florida
United States	Site 194	Mission Viejo	California
United States	Site 206	Missouri City	Texas
United States	Site 198	Monroe	Louisiana
United States	Site 214	Norwalk	Connecticut
United States	Site 161	Okeechobee	Florida
United States	Site 195	Oklahoma City	Oklahoma
United States	Site 189	Phoenix	Arizona
United States	Site 200	Phoenix	Arizona
United States	Site 196	Richmond	Texas
United States	Site 211	Roanoke	Virginia
United States	Site 191	Rochester	New York
United States	Site 193	Rogers	Arkansas
United States	Site 208	Snellville	Georgia
United States	Site 192	Staten Island	New York
United States	Site 221	Tampa	Florida
United States	Site 197	Temecula	California
United States	Site 220	West Palm Beach	Florida
United States	Site 187	Yuma	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Alto Neuroscience

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	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.	Change over time for up to week 6
Secondary	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)	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.	Change over time for up to week 6
Secondary	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	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.	Change over time for up to week 6
Secondary	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.	Incidence, severity, and relatedness of Adverse Events	Assessed from Day 1 to Week 14
Secondary	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.	Assessment of Heart Rate	Assessed from Day 1 to Week 14
Secondary	To evaluate the safety of ALTO-300 during both the OL and DB periods of the study as measured by the assessment of Weight.	Assessment of Weight	Assessed from Day 1 to Week 14
Secondary	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.	Assessment of Blood Pressure	Assessed from Day 1 to Week 14
Secondary	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).	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.	Assessed from Day 1 to Week 15