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Apimostinel + Automated Neurocognitive Training for Depression

NCT06400121 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2025-09-24

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Apimostinel Infusion, Intravenous

Single injection of Apimostinel (10mg)

BEHAVIORAL

Cognitive Training

8 sessions of digital active training

BEHAVIORAL

Sham Training

8 sessions of digital sham training

DRUG

Isotonic Solution, Intravenous

Single injection of placebo

Sponsors & Collaborators

  • Syndeio Biosciences, Inc

    collaborator INDUSTRY

  • Rebecca Price

    lead OTHER

Principal Investigators

  • Rebecca B Price, PhD · University of Pittsburgh

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-28
Primary Completion
2029-03-01
Completion
2029-12-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06400121 on ClinicalTrials.gov