ALTO-207 in Adults With Treatment-resistant Depression (TRD)
ConditionTreatment-resistant Depression (TRD)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorAlto Neuroscience
About this trial
The purpose of this trial is to measure depressive symptoms following treatment with ALTO-207 compared with placebo in participants with TRD.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male and female participants, ages 18 to 75 years, inclusive, at the time of signing the ICF.
Prior diagnosis of MDD without psychotic symptoms (in the current episode) and have confirmatory diagnosis of current MDD (moderate to severe).
Failure to respond (<50% improvement) to at least 2-5 antidepressant treatments (including the current treatment)
Currently taking a stable dose of at least 1 but no more than 2 oral antidepressants at baseline
Disqualifiers
Evidence of unstable medical condition
Concurrent use of any prohibited medications or substance use disorder
Diagnosed bipolar disorder or a psychotic disorder or symptoms
Significant current PTSD symptoms or history of PTSD
Trial design
Design model
Parallel
Treatments tested in this trial
ALTO-207
DrugALTO-207 BID
Placebo
DrugMatching Placebo
Treatment groups
178 Participants
are divided into 2 treatment groupsGroup A: ALTO-207Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in the MADRS total score
Montgomery Asberg Depression Rating Scale (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 from baseline up to 8 weeksSecondary outcomes
1
Change in response (≥50% improvement) raters based on MADRS
Montgomery Asberg Depression Rating Scale (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 from baseline up to 8 weeks2
Change in the Clinician-administered CGI-S score over time from Baseline to Week 8
The Clinician Global Impression-Severity scale (CGI-S) is a 7-point global assessment scale that measures the clinician's impression of the severity of illness exhibited by a participant, rating according to: 1=normal (not at all ill); 2=borderline ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; and 7=among the most extremely ill participants. Higher scores represent a more severe condition.
Time frame
Change from baseline up to 8 weeksSponsors and contacts
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Source ClinicalTrials.gov