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Study of ALTO-300 in MDD

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ClinicalTrials.gov Identifier: NCT05922878
Recruitment Status : Recruiting
First Posted : June 28, 2023
Last Update Posted : February 8, 2024
Sponsor:
Information provided by (Responsible Party):
Alto Neuroscience

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
Estimated 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
Actual Study Start Date : June 8, 2023
Estimated Primary Completion Date : July 2024
Estimated Study Completion Date : October 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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Primary Outcome Measures :
  1. 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). [ Time Frame: 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 :
  1. 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) [ Time Frame: 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.

  2. 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 [ Time Frame: 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.

  3. 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. [ Time Frame: Assessed from Day 1 to Week 14 ]
    Incidence, severity, and relatedness of Adverse Events

  4. 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. [ Time Frame: Assessed from Day 1 to Week 14 ]
    Assessment of Heart Rate

  5. To evaluate the safety of ALTO-300 during both the OL and DB periods of the study as measured by the assessment of Weight. [ Time Frame: Assessed from Day 1 to Week 14 ]
    Assessment of Weight

  6. 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. [ Time Frame: Assessed from Day 1 to Week 14 ]
    Assessment of Blood Pressure

  7. 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). [ Time Frame: 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
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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05922878


Contacts
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Contact: Alto Neuroscience 650-200-0412 clinical@altoneuroscience.com

Locations
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Sponsors and Collaborators
Alto Neuroscience
Investigators
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Study Director: Adam Savitz, MD, PhD Alto Neuroscience
More Information
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Responsible Party: Alto Neuroscience
ClinicalTrials.gov Identifier: NCT05922878    
Other Study ID Numbers: ALTO-300-201
First Posted: June 28, 2023    Key Record Dates
Last Update Posted: February 8, 2024
Last Verified: February 2024

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Depressive Disorder
Depression
Depressive Disorder, Major
 Mood Disorders
Mental Disorders
Behavioral Symptoms