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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed 4 times over a 6 week interval, from day 1 to week 6
Summary
This trial is testing ALTO-100, a new treatment for depression, to see if it works better than other treatments. It will be used alone or with other antidepressants to find out if it helps reduce symptoms of depression.
Who is the study for?
This trial is for adults with moderate to severe major depressive disorder (MDD). Participants can be on a stable dose of certain antidepressants or not on medication. They must not be pregnant, breastfeeding, have unstable medical conditions, substance use disorders, other mental health diagnoses like bipolar or psychotic disorders, dementia, or allergies to ALTO-100.
What is being tested?
The study is testing the effectiveness of ALTO-100 compared to a placebo in treating MDD. It will look at how well it works alone or alongside an existing antidepressant. The goal is to see if patient characteristics influence the outcome.
What are the potential side effects?
While specific side effects are not listed here, common side effects from treatments like ALTO-100 may include nausea, headache, sleep disturbances and potential allergic reactions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ assessed 4 times over a 6 week interval, from day 1 to week 6
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed 4 times over a 6 week interval, from day 1 to week 6
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 ALTO-100 versus placebo on symptoms of MDD in a pre-defined subgroup of participants as measured by the change from Day 1 to Week 6 on the Montgomery-Åsberg Depression Rating Scale (MADRS) total score.
Secondary study objectives
To assess efficacy of ALTO-100 versus placebo for MDD as measured by the change from Day 1 to Week 6 in Clinician Global Impression Scale-severity (CGI-S).
To assess efficacy of ALTO-100 versus placebo for MDD as measured by the change from Day 1 to Week 6 in Patient Health Questionnaire, 9 item (PHQ-9).
To assess efficacy of ALTO-100 versus placebo for symptoms of MDD in a pre-defined subgroup of participants who are taking ALTO-100 as monotherapy for MDD as measured by the change from Day 1 to Week 6 on the MADRS total score.
+7 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: ALTO-100Experimental Treatment1 Intervention
Participants will receive ALTO-100 tablet twice daily, 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-100 tablet twice daily from OL baseline until the end of OL period/early termination visit (Up to 7 weeks).
Group II: Placebo DBPlacebo Group1 Intervention
Participants will receive matching placebo tablet twice daily, from Day 1 to Day 42 in double blind (DB) treatment period.
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Who is running the clinical trial?
Alto NeuroscienceLead Sponsor
9 Previous Clinical Trials
837 Total Patients Enrolled
8 Trials studying Depression
765 Patients Enrolled for Depression
Adam Savitz, MD, PhDStudy DirectorAlto Neuroscience
1 Previous Clinical Trials
200 Total Patients Enrolled
1 Trials studying Depression
200 Patients Enrolled for Depression
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a health condition that is not stable.I am not currently in, nor have I recently been in, a mental illness study with new treatments or devices.You must not be expecting or lactating at the time of enrollment and for the duration of the study.I am not on antidepressants or have been on one type for at least 6 weeks without changes.I have been diagnosed with moderate to severe depression.I have been diagnosed with moderate to severe depression.You are amenable to undertaking all study assessments and procedures.I am not on antidepressants or have been on one type for at least 6 weeks without recent dose changes.I am not on antidepressants or have been on one type for 6 weeks without changes.I have been diagnosed with moderate to severe depression.
Research Study Groups:
This trial has the following groups:- Group 1: ALTO-100
- Group 2: Placebo DB
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: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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