Actively Recruiting

Phase 4
Age: 18Years - 35Years
All Genders
NCT06969755

Biomarkers to Enhance Early Schizophrenia Treatment

Led by Northwell Health · Updated on 2026-04-27

180

Participants Needed

2

Research Sites

252 weeks

Total Duration

On this page

Sponsors

N

Northwell Health

Lead Sponsor

N

National Institute of Mental Health (NIMH)

Collaborating Sponsor

AI-Summary

What this Trial Is About

This study is recruiting participants who are experiencing a first episode of psychosis and who have certain genetic factors that may make them respond better to certain medications that are used to treat people with psychosis.

CONDITIONS

Official Title

Biomarkers to Enhance Early Schizophrenia Treatment

Who Can Participate

Age: 18Years - 35Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 18 to 35
  • Diagnosed with schizophrenia, schizoaffective disorder, or schizophreniform disorder by SCID5
  • Current positive symptoms rated moderate or higher on BPRS positive subscale items
  • Preserved striatal connectivity shown by MRI scan
  • No high-risk MC4R genotype based on genetic testing
  • No high-risk HLA-DQB1 genotype based on genetic testing
  • Early phase of illness with 4 weeks or less cumulative lifetime antipsychotic use
  • Ability to provide informed consent
Not Eligible

You will not qualify if you...

  • Serious neurological or endocrine disorder affecting study results
  • Abnormal EKG interfering with study results
  • Medical condition needing psychotropic medication treatment
  • Significant risk of suicidal or homicidal behavior
  • Cognitive limitations or inability to provide informed consent
  • Contraindications to MRI such as pacemaker
  • Moderate or severe substance use disorder within 3 months except nicotine
  • Mild substance use disorder for certain substances within 3 months or positive drug screen
  • Suspected intellectual disability with IQ score below 71
  • Prior psychosurgery
  • Pregnancy
  • Seizure disorder

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Feinstein Institute for Medical Research

Glen Oaks, New York, United States, 11004

Actively Recruiting

2

Centre for Addiction and Mental Health

Toronto, Canada

Actively Recruiting

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Research Team

P

Patricia Marcy

CONTACT

C

Cristina Gonzalez

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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