Phase 2b Study of ALTO-100 in MDD

Major Depressive Disorder Clinical Trial

Official title:

A Randomized, Double-Blind, Placebo-Controlled Study of ALTO-100 With an Open-Label Extension in Adults With Major Depressive Disorder

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05712187
• Other study ID #: ALTO-100-201
• Status: Recruiting
• Phase: Phase 2
• Start date: January 10, 2023
• Est. completion date: September 27, 2024

Study information

• Verified date: January 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-100 and placebo, used either as monotherapy or adjunctively to an antidepressant, related to patient characteristics.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 266
• Est. completion date: September 27, 2024
• Est. primary completion date: August 2, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• ALTO-100
ALTO-100 tablet BID
• Placebo
Placebo tablet BID

Locations

Country	Name	City	State
United States	Site 178	Albuquerque	New Mexico
United States	Site 151	Baltimore	Maryland
United States	Site 174	Birmingham	Alabama
United States	Site 184	Brooklyn	New York
United States	Site 186	Brooksville	Florida
United States	Site 137	Carmel	Indiana
United States	Site 185	Centennial	Colorado
United States	Site 136	Chandler	Arizona
United States	Site 141	Costa Mesa	California
United States	Site 121	Draper	Utah
United States	Site 147	Fort Worth	Texas
United States	Site 118	Fresno	California
United States	Site 120	Houston	Texas
United States	Site 172	Houston	Texas
United States	Site 173	Huntsville	Alabama
United States	Site 181	Imperial	California
United States	Site 108	Jackson	Mississippi
United States	Site 171	Jackson	Mississippi
United States	Site 204	Jacksonville	Florida
United States	Site 144	Las Vegas	Nevada
United States	Site 142	Lincoln	Nebraska
United States	Site 139	Little Rock	Arkansas
United States	Site 183	Memphis	Tennessee
United States	Site 180	New York	New York
United States	Site 210	New York	New York
United States	Site 157	North Charleston	South Carolina
United States	Site 182	Oceanside	California
United States	Site 188	Oceanside	California
United States	Site 205	Orlando	Florida
United States	Site 179	Rancho Cucamonga	California
United States	Site 116	Sacramento	California
United States	Site 212	Tampa	Florida
United States	Site 213	Tampa	Florida
United States	Site 175	Westlake	Ohio

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 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.	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 assessed from Day 1 to Week 6
Secondary	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.	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 assessed from Day 1 to Week 6
Secondary	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)	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.	Assessed 4 times over a 6 week interval, from Day 1 to Week 6
Secondary	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).	The CGI-S is a 7-point global assessment scale that measures the clinician's impression of the severity of illness exhibited by a participant, rating according to: 1=normal (not at all ill); 2=borderline ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; and 7=among the most extremely ill participants. Higher scores represent a more severe condition.	Assessed 4 times over a 6 week interval, from Day 1 to Week 6
Secondary	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)	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.	Assessed 4 times over a 6- week interval, from Day 1 to Week 6
Secondary	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).	The PHQ-9 is a 9-item, participant reported outcome measure to assess depressive symptoms. The scale scores each of the 9 symptom domains of the diagnostic and statistical manual of mental disorders-5th edition (DSM-5) major depressive disorder (MDD) criteria. Each item is rated on a 4- point scale (0=not at all, 1=several days, 2=more than half the days, and 3=nearly every day). The participant's item responses are summed to provide a total score (range of 0 to 27), with higher scores indicating greater severity of depressive symptoms.	Assessed 4 times over a 6- week interval, from Day 1 to Week 6
Secondary	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.	Incidence, severity, and relatedness of Adverse Events.	Assessed from Day 1 to Week 13
Secondary	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.	Assessment of Heart Rate.	Assessed from Day 1 to Week 13
Secondary	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.	Assessment of Blood Pressure.	Assessed from Day 1 to Week 13
Secondary	To evaluate the safety of ALTO-100 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 13
Secondary	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).	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 13