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
Qualifiers
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
Treatments tested in this trial
- ALTO-300
- Placebo
Treatment groups
321 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov