The purpose of this study is to determine efficacy differences between ALTO-300 and placebo, used adjunctively to an antidepressant, related to patient characteristics.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
321
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 6
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 6
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.
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Site 200
Phoenix, Arizona, United States
RECRUITINGSite 189
Phoenix, Arizona, United States
WITHDRAWNSite 187
Yuma, Arizona, United States
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Rogers, Arkansas, United States
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Bellflower, California, United States
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Glendale, California, United States
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Lafayette, California, United States
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Los Angeles, California, United States
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Mather, California, United States
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Mission Viejo, California, United States
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Time frame: Change over time for up to week 6
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 14
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 14
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
Time frame: Assessed from Day 1 to Week 14
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
Time frame: Assessed from Day 1 to Week 14
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.
Time frame: Assessed from Day 1 to Week 15