Biomarkers to Enhance Early Schizophrenia Treatment

NCT06969755 | Not Yet Recruiting Phase 4 DMC FDA Drug

• 2 other identifiers: BEEST1R01MH134883-01A1
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

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

Schizophenia Disorder

Keywords

Schizophrenia

Outcome Measures

Primary Outcomes (1)

• Total change in BPRS Symptoms

  To compare the 12-week response rate of CLZ versus FL-APs (both risperidone and aripiprazole) utilizing the BPRS

  12 weeks

Secondary Outcomes (3)

• Weight Gain

  12 weeks

• Agranulocytosis

  12 weeks

• Neutropenia

  12 weeks

Other Outcomes (3)

• Functional MRI

  12 weeks

• Functional Outcome

  12 weeks

• Functional Outcome

  12 weeks

Study Arms (3)

risperidone

ACTIVE COMPARATOR

risperidone treatment provided per protocol

Drug: risperidone

aripiprazole

ACTIVE COMPARATOR

aripiprazole treatment per protocol

Drug: aripiprazole

clozapine

ACTIVE COMPARATOR

clozapine treatment per protocol

Drug: clozapine

Interventions

aripiprazole DRUG

aripiprazole arm (titrated dose)

aripiprazole

risperidone DRUG

risperidone arm (titrated dose)

risperidone

clozapine DRUG

clozapine (titrated dose)

clozapine

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Aged 18 to 35.
• DSM5 diagnosis (as determined by the SCID5) of schizophrenia, schizoaffective disorder, schizophreniform disorder.
• Current positive symptoms rated ≥4 (moderate) on one or more of the following BPRS positive subscale items: unusual thought content, conceptual disorganization, hallucinatory behavior, suspiciousness.
• Preserved striatal connectivity, as determined by screening MRI scan
• Absence of the MC4R high-risk genotype, as determined by genetic testing
• Absence of the HLA-DQB1 high-risk genotype, as determined by genetic testing
• In an early phase of illness as defined by having taken antipsychotic drugs for a cumulative lifetime period of 4 weeks or less (with exceptions of very low doses for other off-label indications, e.g. sleep)
• Ability to provide informed consent

You may not qualify if:

• The patient reports or medical records state a serious neurological or endocrine disorder at screening that the investigator determines could interfere with the interpretation of the efficacy or safety measurements
• An abnormal EKG at screening that the investigator determines could interfere with the interpretation of the efficacy or safety measurements
• Any medical condition which requires treatment with a medication with psychotropic effects.
• Significant risk of suicidal or homicidal behavior (i.e. 'severe' risk on the Columbia Suicide Scale, a 'hostility' score of 7 on the BPRS, or an answer of 'yes' on questions 4,5 or 6 on the CDSS).
• Cognitive limitations, or any other factor that would preclude potential participants providing informed consent
• Contraindications to MRI (e.g. pacemaker).
• Meeting SCID-5 substance use disorder moderate or severe for any substance, other than nicotine within 3 months of screening visit. Meeting SCID5 substance use disorder mild for any substance other than cannabis, alcohol, or nicotine for less than 3 months prior to screening visit, or a positive urine baseline drug screen with a substance other than nicotine, alcohol, or cannabis
• Suspected DSM5 intellectual disability based upon clinical interview and psychosocial history, as well as screening with the Weschler Test for Adult Reading (IQ score \<71)
• Prior psychosurgery
• Pregnancy (self-report)
• Seizure disorder (self-report)

Sponsors & Collaborators

• Northwell Health: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Feinstein Institute for Medical Research

Glen Oaks, New York, 11004, United States

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Aripiprazole; Risperidone; Clozapine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Pyrimidinones; Pyrimidines; Dibenzazepines; Heterocyclic Compounds, 3-Ring

Central Study Contacts

Patricia Marcy

CONTACT

904-302-0811; pmarcy@northwell.edu

Cristina Gonzalez

CONTACT

347-804-3605; cgomes@northwell.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2025
• First Posted: May 14, 2025
• Study Start: July 30, 2025
• Primary Completion (Estimated): July 30, 2030
• Study Completion (Estimated): July 30, 2030
• Last Updated: May 14, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Time Frame: The data will be transferred 12 months after the study starts and then every 6 months
• Access Criteria: Access to the NDA will be controlled by the NDA following their policies and procedures.

Locations

US (1)