RecruitingPhase 2NCT06400121

Apimostinel + Automated Neurocognitive Training for Depression

Phase 2, Randomized, Double-Blind, Placebo-Controlled, Single Intravenous Dose, Parallel Efficacy Study of Apimostinel With or Without Subsequent Automated Self-Association Training in Subjects With Major Depressive Disorder


Sponsor

Rebecca Price

Enrollment

150 participants

Start Date

Oct 28, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

Apimostinel shows initial promise as a novel rapid-acting antidepressant medication with minimal side effects or safety concerns. Cognitive Training (CT) is a digital intervention that has shown promise in extending the durability of another similar drug (ketamine). This randomized controlled trial will test the efficacy and safety of apimostinel (vs. placebo) for the acute treatment of depression, and will test the potential of CT to enhance and/or extend the durability of apimostinel's antidepressant effect.


Eligibility

Min Age: 18 YearsMax Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a drug called apimostinel (a single IV infusion that works differently from standard antidepressants) combined with an automated computer-based brain training program can reduce negative self-thinking patterns in people with depression. **You may be eligible if...** - You are between 18 and 60 years old - You have been diagnosed with major depressive disorder (MDD) - Your depression severity score is 20 or higher on a standard scale - You have significant negative self-esteem or self-critical thinking - You are not currently pregnant and are using appropriate birth control **You may NOT be eligible if...** - You have bipolar disorder, psychosis, or autism spectrum disorder - You have used a specific type of antidepressant called an MAOI in the past 28 days - You have Parkinson's, Alzheimer's, Huntington's, multiple sclerosis, or a history of seizures or stroke - You are currently hospitalized in a psychiatric facility - You have active suicidal thoughts with intent or a plan - You have uncontrolled high blood pressure or kidney or liver problems - You take certain medications that interact with the study drug (ketamine-related drugs, memantine, some others) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGApimostinel Infusion, Intravenous

Single injection of Apimostinel (10mg)

BEHAVIORALCognitive Training

8 sessions of digital active training

BEHAVIORALSham Training

8 sessions of digital sham training

DRUGIsotonic Solution, Intravenous

Single injection of placebo


Locations(1)

Western Psychiatric Institute and Clinic

Pittsburgh, Pennsylvania, United States

View Full Details on ClinicalTrials.gov

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NCT06400121


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