Study of ALTO-300 in MDD

Sponsor

Alto Neuroscience (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05922878

Collaborator

(none)

200

Enrollment

Locations

Arms

Anticipated Duration (Months)

66.7

Patients Per Site

4.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Major Depressive Disorder	Drug: ALTO-300 Drug: Placebo	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jun 1, 2023

Anticipated Primary Completion Date :

Jul 1, 2024

Anticipated Study Completion Date :

Oct 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ALTO-300 Participants will receive ALTO-300 capsule once daily in the evening, from Day 1 to Day 42 in double blind (DB) treatment period. Eligible participants who will enter the open-label (OL) treatment period will receive ALTO-300 capsule once daily in the evening from OL baseline until the end of OL period/early termination visit (Up to 8 weeks).	Drug: ALTO-300 ALTO-300 capsule QD
Placebo Comparator: Placebo Participants will receive matching placebo capsule once daily in the evening, from Day 1 to Day 42 in double blind (DB) treatment period.	Drug: Placebo Placebo capsule QD

Arm

Intervention/Treatment

Experimental: ALTO-300

Participants will receive ALTO-300 capsule once daily in the evening, from Day 1 to Day 42 in double blind (DB) treatment period. Eligible participants who will enter the open-label (OL) treatment period will receive ALTO-300 capsule once daily in the evening from OL baseline until the end of OL period/early termination visit (Up to 8 weeks).

Drug: ALTO-300

ALTO-300 capsule QD

Placebo Comparator: Placebo

Participants will receive matching placebo capsule once daily in the evening, from Day 1 to Day 42 in double blind (DB) treatment period.

Drug: Placebo

Placebo capsule QD

Outcome Measures

Primary Outcome Measures

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). [Change over time for up to week 6]
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.

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 64 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Site 189	Phoenix	Arizona	United States	85021
2	Site 187	Yuma	Arizona	United States	85364
3	Site 161	Okeechobee	Florida	United States	34972

Sponsors and Collaborators

Alto Neuroscience

Investigators

Study Director: Adam Savitz, MD, PhD, Alto Neuroscience

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Alto Neuroscience

ClinicalTrials.gov Identifier:

NCT05922878

Other Study ID Numbers:

ALTO-300-201

First Posted:

Jun 28, 2023

Last Update Posted:

Jun 28, 2023

Last Verified:

Jun 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Depressive Disorder

Depression

Depressive Disorder, Major

Study Results

No Results Posted as of Jun 28, 2023