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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 from day 1 to week 15
Awards & highlights
Study Summary
This trial tests if a drug helps depression when used with an antidepressant, and if it works better for certain people.
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.Check my eligibility
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 patient characteristics influence how well ALTO-300 works.See study design
What are the potential side effects?
While specific side effects are not listed here, common side effects from treatments like ALTO-300 may include nausea, headache, sleep disturbances, and potential interaction with other medications.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ assessed from day 1 to week 15
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed from day 1 to week 15
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 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 outcome measures
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.
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Who is running the clinical trial?
Alto NeuroscienceLead Sponsor
7 Previous Clinical Trials
771 Total Patients Enrolled
7 Trials studying Depression
771 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
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I've been on the same dose of an SSRI, SNRI, or bupropion for at least 6 weeks.I have been diagnosed with moderate to severe depression.I am not currently in, nor have I recently been in, a mental illness study with new treatments or devices.I've been on the same dose of SSRI, SNRI, or bupropion for at least 6 weeks.I use sleep medication every night.I have a health condition that is currently not stable.
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: 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.
Are there currently any vacancies available for individuals wishing to participate in the trial?
"Per the data hosted on clinicaltrials.gov, this trial is still actively recruiting patients; it was posted on June 1st 2023 and has recently been updated as of 19th of that same month."
Answered by AI
Does ALTO-300 have regulatory clearance from the FDA?
"ALTO-300 has an estimated safety rating of 2, as it is in Phase 2; although there are several assessments which support its security, no clinical trials have been conducted to determine efficacy."
Answered by AI
Is this research open to participants aged 50 and above?
"According to the study's inclusion criteria, this trial is open for patients between 18 and 64 years old. For minors or seniors there are 209 trials specifically targeting those below age 18 and 997 studies focused on individuals older than 65 respectively."
Answered by AI
Is there a way I can participate in this research project?
"To be eligible for this clinical trial, 200 patients must meet the criteria of suffering from depression and being between 18 and 64 years old."
Answered by AI
What is the aggregate number of study participants enrolled in this trial?
"Affirmative. Clinicaltrials.gov reveals that this clinical trial is currently recruiting individuals; the initial posting was published on June 1st 2023, with its most recent alteration taking place on June 19th 2023. To progress forward 200 participants must be sourced from 3 distinct medical centres."
Answered by AI
Who else is applying?
What site did they apply to?
Site 189
Site 161
Site 192
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
Why did patients apply to this trial?
I am only doing therapy at this time n am looking for further options. I've tried several other medications that provided only marginal effectiveness. My hope is that a different medication will provide better efficacy.
PatientReceived 1 prior treatment
I tried at least 5 or more medications for my depression and does not seem to be helping. So thought give clinical research trial and see if something new might help.
PatientReceived 2+ prior treatments
I've been on so many different antidepressants, single and combinations of for over 20 years on and off, along with therapy. Some have worked for awhile but then they don't, and some haven't worked at all.
PatientReceived 2+ prior treatments
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