Study of ALTO-300 in MDD

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Primary Purpose

Status

Recruiting

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

ALTO-300

Placebo

About this trial

This is an interventional treatment trial for Major Depressive Disorder

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept 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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

ALTO-300

Placebo

Arm Description

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).

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

Outcomes

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).

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)

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

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.

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.

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.

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.

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).

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.

Full Information

NCT ID

NCT05922878

First Posted

May 26, 2023

Last Updated

October 10, 2023

Sponsor

Alto Neuroscience

1. Study Identification

Unique Protocol Identification Number

NCT05922878

Brief Title

Study of ALTO-300 in MDD

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Recruiting

Study Start Date

June 8, 2023 (Actual)

Primary Completion Date

July 2024 (Anticipated)

Study Completion Date

October 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Alto Neuroscience

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Major Depressive Disorder

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

ALTO-300

Arm Type

Experimental

Arm Description

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).

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

ALTO-300

Intervention Description

ALTO-300 capsule QD

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo capsule QD

Primary Outcome Measure Information:

Title

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).

Description

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.

Time Frame

Change over time for up to week 6

Secondary Outcome Measure Information:

Title

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)

Description

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.

Time Frame

Change over time for up to week 6

Title

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

Description

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.

Time Frame

Change over time for up to week 6

Title

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.

Description

Incidence, severity, and relatedness of Adverse Events

Time Frame

Assessed from Day 1 to Week 14

Title

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.

Description

Assessment of Heart Rate

Time Frame

Assessed from Day 1 to Week 14

Title

To evaluate the safety of ALTO-300 during both the OL and DB periods of the study as measured by the assessment of Weight.

Description

Assessment of Weight

Time Frame

Assessed from Day 1 to Week 14

Title

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.

Description

Assessment of Blood Pressure

Time Frame

Assessed from Day 1 to Week 14

Title

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).

Description

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.

Time Frame

Assessed from Day 1 to Week 15

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

64 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Alto Neuroscience

Phone

650-200-0412

Email

clinical@altoneuroscience.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Adam Savitz, MD, PhD

Organizational Affiliation

Alto Neuroscience

Official's Role

Study Director

Facility Information:

Facility Name

Site 200

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85012

Country

United States

Individual Site Status

Recruiting

Facility Name

Site 189

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85021

Country

United States

Individual Site Status

Recruiting

Facility Name

Site 187

City

Yuma

State/Province

Arizona

ZIP/Postal Code

85364

Country

United States

Individual Site Status

Recruiting

Facility Name

Site 193

City

Rogers

State/Province

Arkansas

ZIP/Postal Code

72758

Country

United States

Individual Site Status

Recruiting

Facility Name

Site 194

City

Mission Viejo

State/Province

California

ZIP/Postal Code

92691

Country

United States

Individual Site Status

Recruiting

Facility Name

Site 197

City

Temecula

State/Province

California

ZIP/Postal Code

92591

Country

United States

Individual Site Status

Recruiting

Facility Name

Site 203

City

Colorado Springs

State/Province

Colorado

ZIP/Postal Code

80918

Country

United States

Individual Site Status

Recruiting

Facility Name

Site 159

City

Clermont

State/Province

Florida

ZIP/Postal Code

34711

Country

United States

Individual Site Status

Recruiting

Facility Name

Site 190

City

Miami Lakes

State/Province

Florida

ZIP/Postal Code

33016

Country

United States

Individual Site Status

Recruiting

Facility Name

Site 161

City

Okeechobee

State/Province

Florida

ZIP/Postal Code

34972

Country

United States

Individual Site Status

Recruiting

Facility Name

Site 119

City

Boise

State/Province

Idaho

ZIP/Postal Code

83702

Country

United States

Individual Site Status

Recruiting

Facility Name

Site 201

City

Marrero

State/Province

Louisiana

ZIP/Postal Code

70072

Country

United States

Individual Site Status

Recruiting

Facility Name

Site 198

City

Monroe

State/Province

Louisiana

ZIP/Postal Code

71201

Country

United States

Individual Site Status

Recruiting

Facility Name

Site 114

City

Albuquerque

State/Province

New Mexico

ZIP/Postal Code

87108

Country

United States

Individual Site Status

Recruiting

Facility Name

Site 191

City

Rochester

State/Province

New York

ZIP/Postal Code

14618

Country

United States

Individual Site Status

Recruiting

Facility Name

Site 192

City

Staten Island

State/Province

New York

ZIP/Postal Code

10314

Country

United States

Individual Site Status

Recruiting

Facility Name

Site 199

City

Hickory

State/Province

North Carolina

ZIP/Postal Code

28601

Country

United States

Individual Site Status

Recruiting

Facility Name

Site 202

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45215

Country

United States

Individual Site Status

Recruiting

Facility Name

Site 195

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73112

Country

United States

Individual Site Status

Recruiting

Facility Name

Site 196

City

Richmond

State/Province

Texas

ZIP/Postal Code

77407

Country

United States

Individual Site Status

Recruiting

Facility Name

Site 207

City

Clinton

State/Province

Utah

ZIP/Postal Code

84015

Country

United States

Individual Site Status

Recruiting

Major Depressive Disorder

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial