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
Qualifiers
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
Treatments tested in this trial
- ALTO-207
- Placebo
Treatment groups
178 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov