Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 75
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
178 (estimated)
Sponsor
Alto Neuroscience · Industry
Who this trial is looking for
This trial is looking for adults aged 18 to 75 who have moderate to severe depression that hasn't improved with other treatments. Participants will compare the effects of ALTO-207 with a placebo.
Are You a Good Fit for This Trial?
You may be able to join if
I am between 18 and 75 years old.
I have been diagnosed with major depressive disorder (MDD) without psychotic symptoms.
I have not responded to 2 to 5 different antidepressants.
I am currently taking 1 or 2 stable oral antidepressants.
You may not be able to join if
I have an unstable medical condition.
I have a substance use disorder.
I have been diagnosed with bipolar disorder.
I have significant current PTSD symptoms.
I have serious impulse control problems.
I am allergic to ALTO-207 or any of its ingredients.
I have recently participated in another mental health clinical trial.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
The purpose of this trial is to measure depressive symptoms following treatment with ALTO-207 compared with placebo in participants with TRD.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* 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% improveme…
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
* Clinically significant current impulse control difficulties
* Has a history of hypersensitivity or allergic reaction to ALTO-207 or any of its components/excipients
* Concurrent or recent participation in another clinical trial for mental illness involving an investigational product or device
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