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ALTO-100 for Depression

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Site 179, Rancho Cucamonga, CADepressionALTO-100 - Drug
Eligibility
18 - 64
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions
  • Depression

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Study Objectives

1 Primary · 12 Secondary · Reporting Duration: Assessed 4 times over a 6 week interval, from Day 1 to Week 6

Week 6
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 MDD.
To assess efficacy of ALTO-100 vs placebo for MDD as measured by the change from Day 1 to Week 6 in response (>50% improvement from baseline) and remission (total MADRS score of <10) rates based on the Montgomery-Åsberg Depression Rating Scale (MADRS)
Week 13
To evaluate the safety of ALTO-100 during both the OL and DB periods of the study as measured by the assessment of Blood Pressure.
To evaluate the safety of ALTO-100 during both the OL and DB periods of the study as measured by the assessment of Heart Rate.
To evaluate the safety of ALTO-100 during both the OL and DB periods of the study as measured by the assessment of Weight.
To evaluate the safety of ALTO-100 during both the OL and DB periods of the study as measured by the assessment of suicidality with the Concise Health Risk Tracking Self-Report,12 item scale (CHRT-SR12).
To evaluate the safety of ALTO-100 during both the OL and DB periods of the study as measured by the assessment of the incidence, severity, and relatedness of Adverse Events.
To evaluate the safety of ALTO-100 during both the OL and DB periods of the study.
Week 6
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 in the Montgomery-Åsberg Depression Rating Scale (MADRS).
To assess efficacy of ALTO-100 versus placebo on symptoms of MDD in all randomized participants as measured by the change from Day 1 to Week 6 on the Montgomery-Åsberg Depression Rating Scale (MADRS)
To assess efficacy of ALTO-100 versus placebo on symptoms of MDD in all randomized participants.

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

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Trial Design

2 Treatment Groups

ALTO-100
1 of 2
Placebo DB
1 of 2

Experimental Treatment

Non-Treatment Group

200 Total Participants · 2 Treatment Groups

Primary Treatment: ALTO-100 · Has Placebo Group · Phase 2

ALTO-100
Drug
Experimental Group · 1 Intervention: ALTO-100 · Intervention Types: Drug
Placebo DB
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: assessed 4 times over a 6 week interval, from day 1 to week 6

Who is running the clinical trial?

Alto NeuroscienceLead Sponsor
6 Previous Clinical Trials
514 Total Patients Enrolled
6 Trials studying Depression
514 Patients Enrolled for Depression
Adam Savitz, MD, PhDStudy DirectorAlto Neuroscience

Eligibility Criteria

Age 18 - 64 · All Participants · 4 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have been diagnosed with moderate to severe depression.

Who else is applying?

What state do they live in?
Texas100.0%
What portion of applicants met pre-screening criteria?
Met criteria66.7%
Did not meet criteria33.3%
How many prior treatments have patients received?
1100.0%
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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