Study of ALTO-300 in MDD
ConditionMajor Depressive Disorder
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorAlto Neuroscience
About this trial
The purpose of this study is to determine efficacy differences between ALTO-300 and placebo, used adjunctively to an antidepressant, related to patient characteristics.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Have a diagnosis of moderate to severe major depressive disorder (MDD)
At Visit 1, currently taking a single SSRI, SNRI, or bupropion for at least 6 weeks with no dose modifications in the past 2 weeks by Visit 2
Willing to comply with all study assessments and procedures
Must not be pregnant or breastfeeding at time of enrollment or throughout study
Disqualifiers
Evidence of unstable medical condition
Nightly use of sleep medication
Diagnosed bipolar disorder, psychotic disorder, or dementia
Current moderate or severe substance use disorder
Trial design
Design model
Parallel
Treatments tested in this trial
ALTO-300
DrugALTO-300 capsule QD
Placebo
DrugPlacebo capsule QD
Treatment groups
321 Participants
are divided into 2 treatment groupsGroup A: ALTO-300Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
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).
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 6Secondary outcomes
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)
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 62
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.
Time frame
Change over time for up to week 63
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
Time frame
Assessed from Day 1 to Week 144
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
Time frame
Assessed from Day 1 to Week 14Sponsors and contacts
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Source ClinicalTrials.gov