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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
Awards & highlights
Study Summary
This trial will compare two treatments for depression. One is a drug, the other is a placebo. Both can be used on their own or with an antidepressant.
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.Check my eligibility
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.See study design
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
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
7 Previous Clinical Trials
705 Total Patients Enrolled
7 Trials studying Depression
705 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
Media Library
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What criteria must be fulfilled in order to qualify for this research project?
"This clinical trial is accepting 200 participants with a diagnosis of depression aged between 18 and 64 years old."
Answered by AI
How many distinct sites are engaged in conducting this experiment?
"Site 141 in Costa Mesa, California, Site 118 in Fresno, Maryland and Site 116 in Sacramento, Nebraska are just some of the 11 trial centres conducting this clinical study."
Answered by AI
How has ALTO-100 been assessed for patient safety?
"Our team at Power rated ALTO-100's safety with a score of 2 due to the availability of Phase 2 data, which provides support for its security but not yet efficacy."
Answered by AI
Are older individuals within the age range of 30 and above suitable for this trial?
"To participate in this study, patients must be within the 18 to 64 age bracket. However, there are an additional 184 and 961 trials respectively for minors and seniors."
Answered by AI
Are enrollment slots still available for this scientific endeavor?
"According to the details on clinicaltrials.gov, this health investigation is still open for enrollment. It was first launched on 10th of January in 2023 and has since been updated most recently on 25th of Janurary that same year."
Answered by AI
To what extent has enrollment been undertaken for this research?
"Affirmative. The information on clinicaltrials.gov reveals that this trial is currently recruiting participants, with the initial posting occurring on January 10th 2023 and the last update being made on January 25th 2023. 200 patients are required to be recruited from 11 distinct medical sites."
Answered by AI
Who else is applying?
What state do they live in?
Arkansas
California
Other
Texas
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
1
3+
What site did they apply to?
Site 139
Site 116
Site 172
Other
Why did patients apply to this trial?
Wanting to find a medication that works. I’ve tried many medications throughout the years but have yet to find one that works.
PatientReceived 1 prior treatment
I’ve tried multiple medications and methods to help my depression over the course of my life and everything only makes life bearable. I would like to see better results for myself as well as help others like me!
PatientReceived 2+ prior treatments
I've been going through a depressive episode since near the end of highschool (2022) and despite multiple medications and even TMS treatment in 2023, I feel as if I'm stuck. I have improved but not enough to feel functional as a normal person. I have regular sad spells and days of leaden depression. I'm applying to trials (especially that let me take my current medications) hoping I can get enough of a breakthrough to become more independent. Please consider having me on the trial. Thank you for your consideration.
PatientReceived 2+ prior treatments
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