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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Have a diagnosis of moderate to severe major depressive disorder (MDD)
Are you taking any medication for depression?
Must not have
Has your antidepressant significantly improved your depression?
Do you drink alcohol or use drugs like marijuana every day?
Timeline
Screening 3 weeks
Treatment 6 weeks
Follow Up 7 days
Awards & highlights
Summary
This trial is testing ALTO-300, a new medication, to see if it can make antidepressants work better for patients who are already taking them.
Who is the study for?
This trial is for adults with moderate to severe major depressive disorder (MDD) who have been on a steady dose of an SSRI, SNRI, or bupropion for at least 6 weeks. Participants must be willing to follow study procedures and cannot be pregnant or breastfeeding.
What is being tested?
The study is testing the effectiveness of ALTO-300 compared to a placebo when used alongside an antidepressant. The goal is to see if patients meet the rater-administered HDRS, MADRS, and CGI-S end points.
What are the potential side effects?
There are no adverse side effects from ALTO-300.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowExclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Timeline
Screening ~ 3 weeks3 visits
Treatment ~ 6 weeks6 visits
Follow Up ~ 7 days1 visit
Screening ~ 3 weeks
Treatment ~ 6 weeks
Follow Up ~7 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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).
Secondary study objectives
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
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)
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.
+4 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: ALTO-300Experimental Treatment1 Intervention
Participants will receive ALTO-300 capsule once daily in the evening, from Day 1 to Day 42 in double blind (DB) treatment period. Eligible participants who will enter the open-label (OL) treatment period will receive ALTO-300 capsule once daily in the evening from OL baseline until the end of OL period/early termination visit (Up to 8 weeks).
Group II: PlaceboPlacebo Group1 Intervention
Participants will receive matching placebo capsule once daily in the evening, from Day 1 to Day 42 in double blind (DB) treatment period.
Find a Location
Who is running the clinical trial?
Alto NeuroscienceLead Sponsor
9 Previous Clinical Trials
903 Total Patients Enrolled
8 Trials studying Depression
831 Patients Enrolled for Depression
Adam Savitz, MD, PhDStudy DirectorAlto Neuroscience
1 Previous Clinical Trials
266 Total Patients Enrolled
1 Trials studying Depression
266 Patients Enrolled for Depression
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with moderate to severe depression.I've been on the same dose of SSRI, SNRI, or bupropion for at least 6 weeks.I've been on the same dose of an SSRI, SNRI, or bupropion for at least 6 weeks.
Research Study Groups:
This trial has the following groups:- Group 1: ALTO-300
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: You will receive the treatment for 6 Weeks
- Follow Ups: You may be asked to continue sharing information regarding the trial for 7 Months after you stop receiving the treatment.
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