Actively Recruiting
Biomarkers to Enhance Early Schizophrenia Treatment with Clozapine, Risperidone, or Aripiprazole in First Episode Psychosis
Led by Northwell Health · Updated on 2026-05-26
180
Participants Needed
4
Research Sites
N/A
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
Researchers are evaluating treatments for people experiencing their first episode of psychosis who have specific genetic markers that might influence how they respond to medications. The study focuses on comparing the effects of clozapine with standard antipsychotics, risperidone and aripiprazole, in patients identified with three important biomarkers related to treatment response, risk of side effects, and weight gain. This phase 4 trial aims to better tailor early schizophrenia treatment based on these biomarkers. Participants will be randomly assigned to receive one of three medications: clozapine, risperidone, or aripiprazole. Before enrollment, they undergo a screening process including a resting-state functional MRI scan and blood tests to check for specific genetic factors. Those who do not meet the biomarker criteria will not be enrolled but will still receive usual care. The treatments are given according to protocol with doses adjusted as needed. Study participants will be assessed for changes in psychiatric symptoms over 12 weeks using the Brief Psychiatric Rating Scale. Researchers will also monitor weight changes and blood counts to detect side effects like agranulocytosis and neutropenia. The study includes careful safety monitoring and follows participants during the treatment period to evaluate outcomes and any adverse effects.
CONDITIONS
Brief Title
Biomarkers to Enhance Early Schizophrenia Treatment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 to 35 years
- Diagnosed with schizophrenia, schizoaffective disorder, or schizophreniform disorder according to DSM-5
- Current moderate or higher positive psychotic symptoms on BPRS scale
- Preserved striatal connectivity shown by MRI scan
- Absence of high-risk MC4R genotype per genetic testing
- Absence of high-risk HLA-DQB1 genotype per genetic testing
- Early phase of illness with antipsychotic use of 4 weeks or less lifetime
- Able to provide informed consent
You will not qualify if you...
- Serious neurological or endocrine disorder affecting study results
- Abnormal EKG interfering with safety or efficacy assessments
- Medical conditions requiring psychotropic medications
- Significant risk of suicide or violence
- Cognitive impairment preventing informed consent
- Contraindication to MRI (e.g., pacemaker)
- Moderate or severe substance use disorder within 3 months, except nicotine
- Mild substance use disorder within 3 months for some substances or positive drug screen
- Suspected intellectual disability (IQ below 71)
- Prior brain surgery (psychosurgery)
- Pregnancy
- Seizure disorder
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for MRI scan and blood draw
Duration - 12 weeks
Participants receive treatment with clozapine, risperidone, or aripiprazole based on their biomarker status and randomization.
Weekly visits for up to 12 weeks
Trial Site Locations
Total: 4 locations
1
University of California San Diego
La Jolla, California, United States, 92093
Actively Recruiting
2
McLean
Belmont, Massachusetts, United States, 02478
Actively Recruiting
3
Feinstein Institute for Medical Research
Glen Oaks, New York, United States, 11004
Actively Recruiting
4
Centre for Addiction and Mental Health
Toronto, Canada
Actively Recruiting
Research Team
P
Patricia Marcy
C
Cristina Gonzalez
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here