Recruiting NCT05922878

Study of ALTO-300 in MDD

Phase II Interventional Major Depressive Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: ALTO-300, Placebo.
Who it may be relevant to: Registry conditions: Major Depressive Disorder. Basic parameters: 18 years — 70 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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

Interventions

Drug ALTO-300
ALTO-300 capsule QD
Drug Placebo
Placebo capsule QD

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). [Time frame: Change over time for up to week 6]

Secondary outcome measures (7)

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) [Time frame: Change over time for up to week 6]
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 [Time frame: Change over time for up to week 6]
To evaluate the safety of ALTO-300 during both the OL and DB periods of the study as measured by the assessment of the incidence, severity, and relatedness of Adverse Events. [Time frame: Assessed from Day 1 to Week 14]
To evaluate the safety of ALTO-300 during both the OL and DB periods of the study as measured by the assessment of Heart Rate. [Time frame: Assessed from Day 1 to Week 14]
To evaluate the safety of ALTO-300 during both the OL and DB periods of the study as measured by the assessment of Weight. [Time frame: Assessed from Day 1 to Week 14]
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. [Time frame: Assessed from Day 1 to Week 14]
To evaluate the safety of ALTO-300 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). [Time frame: Assessed from Day 1 to Week 15]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Quadruple blind
Primary purpose: Treatment

Study locations

United States · 45 centers

Site 200 — Phoenix
Site 189 — Phoenix
Site 187 — Yuma
Site 193 — Rogers
Site 218 — Bellflower
Site 217 — Glendale
Site 335 — Lafayette
Site 209 — Los Angeles
… and 37 more centers

Identifiers

NCT: NCT05922878 · ALTO-300-201

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗