Actively Recruiting

Phase 2
Age: 18Years - 60Years
All Genders
NCT06400121

Apimostinel + Automated Neurocognitive Training for Depression

Led by Rebecca Price · Updated on 2025-09-24

150

Participants Needed

1

Research Sites

265 weeks

Total Duration

On this page

Sponsors

R

Rebecca Price

Lead Sponsor

S

Syndeio Biosciences, Inc

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Apimostinel + Automated Neurocognitive Training for Depression

Who Can Participate

Age: 18Years - 60Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Participants of any gender aged 18 to 60 years
  • Meets DSM-V criteria for major depressive disorder
  • Montgomery-Asberg Depression Rating Scale (MADRS) score of 20 or higher at screening
  • Cognitive Triad Inventory (CTI) self subscale score more than 1 standard deviation above the norm OR Rosenberg self-esteem scale score more than 1 standard deviation below the norm
  • Negative serum pregnancy test for participants of childbearing potential and use of adequate birth control or surgical sterility/post-menopausal status
  • Use of acceptable birth control methods for participants who could impregnate a partner and their partners during the study period
  • Clinical lab values less than 1.5 times the upper limit of normal or deemed not clinically significant
  • Ability to understand study requirements, provide informed consent, follow study restrictions, and attend required assessments
  • Participants with eating disorders, OCD, panic disorder, PTSD, or generalized anxiety secondary to major depressive episodes may be included based on investigator judgment
Not Eligible

You will not qualify if you...

  • History of bipolar disorder, psychotic disorder, autism spectrum disorder, or current moderate-to-severe substance use disorder
  • Use of Monoamine Oxidase Inhibitors (MAOI) within 28 days before infusion
  • Diagnosis of Huntington's, Parkinson's, Alzheimer's, Multiple Sclerosis, history of strokes, or seizures without resolved cause
  • Current hospitalization or residence in an inpatient facility during study participation
  • Acute suicidality or psychiatric crisis requiring treatment escalation, including active suicidal ideation with intent or plan
  • Changes in treatment regimen within 28 days before infusion
  • Reading level below 6th grade
  • Serious unstable medical illnesses including obstructive sleep apnea, ischemic heart disease, uncontrolled hypertension, or severe neurological injury
  • Clinically significant abnormal lab results, physical exam, or ECG findings
  • Uncontrolled hypertension or clinically significant renal dysfunction (eGFR less than 70 mL/min)
  • Liver enzyme levels more than 2 times the upper limit of normal
  • Resting heart rate less than 60 or greater than 100 bpm without appropriate cause
  • PR interval greater than 250 msec
  • Hormonal treatment started within 3 months before screening
  • Use of medications affecting NMDA, AMPA glutamate, or mu-opioid receptors
  • Use of St John's Wort, theophylline, tramadol, or metrizamide
  • Electroconvulsive therapy (ECT) within 6 months before screening
  • Current treatment with vagus nerve stimulation or repetitive transcranial stimulation
  • Participation in another clinical trial within 30 days before enrollment
  • Positive drug screen for unreported drugs of abuse (except some marijuana use without severe disorder)
  • Participants or partners currently pregnant or planning pregnancy during the study
  • Breastfeeding participants
  • Allergy or sensitivity to apimostinel, zelquistinel, NMDAR ligands, or related drugs

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Western Psychiatric Institute and Clinic

Pittsburgh, Pennsylvania, United States, 15213

Actively Recruiting

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Research Team

R

Rebecca B Price, PhD

CONTACT

C

Crystal Spotts, M.Ed.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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