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RecruitingPhase 2

Study of ALTO-300 in MDD

A Randomized, Double-Blind, Placebo-Controlled Study of ALTO-300 With an Open-Label Extension in Adults With Major Depressive Disorder

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 70 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares ALTO-300 with a placebo (a treatment with no active drug), both added to an antidepressant. It is for people with moderate to severe major depression. The study looks at whether patient traits affect how well the treatment works.

The purpose of this study is to determine efficacy differences between ALTO-300 and placebo, used adjunctively to an antidepressant, related to patient characteristics.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have a diagnosis of moderate to severe major depression.
  • At the first visit, have taken just one antidepressant—an SSRI, SNRI, or bupropion—for at least 6 weeks. Have no dose changes in the 2 weeks before the second visit.
  • Be willing to follow all study tests and steps.
  • Not be pregnant or breastfeeding when joining or during the study.

Who can't join

  • Have a medical condition that is not stable.
  • Use sleep medicine every night.
  • Have bipolar disorder, a psychotic disorder (which can affect your sense of what is real), or dementia (which affects memory and thinking).
  • Currently have a moderate or severe substance use disorder, meaning alcohol or drug use that causes serious problems.
  • Have had an allergic reaction to ALTO-300 or any of its ingredients.
  • Are taking part in, or recently took part in, another mental illness study testing an experimental drug, other product, or device.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Have a diagnosis of moderate to severe major depressive disorder (MDD) * At Visit 1, currently taking a single SSRI, SNRI, or bupropion for at least 6 weeks with no dose modifications in the past 2 weeks by Visit 2 * Willing to comply with all study assessments and procedures * Must not be pregnant or breastfeeding at time of enrollment or throughout study Exclusion Criteria: * Evidence of unstable medical condition * Nightly use of sleep medication * Diagnosed bipolar disorder, psychotic disorder, or dementia * Current moderate or severe substance use disorder * Has a history of hypersensitivity or allergic reaction to ALTO-300 or any of its components/excipients * Concurrent or recent participation in another clinical trial for mental illness involving an investigational product or device

Study sites (45)

AR

AZ

CA

CO

CT

FL

GA

ID

IL

LA

MS

NC

NM

NV

NY

OH

OK

PA

TX

UT

VA