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Biomarkers to Enhance Early Schizophrenia Treatment

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 35
Healthy Volunteers: f
View:

• 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

Locations
United States
Alabama
The University of Alabama at Birmingham
RECRUITING
Birmingham
California
University of California San Diego
RECRUITING
La Jolla
Massachusetts
McLean
RECRUITING
Belmont
New York
Feinstein Institute for Medical Research
RECRUITING
Glen Oaks
Other Locations
Canada
Centre for Addiction and Mental Health
RECRUITING
Toronto
Contact Information
Primary
Patricia Marcy
pmarcy@northwell.edu
904-302-0811
Backup
Cristina Gonzalez
cgomes@northwell.edu
347-804-3605
Time Frame
Start Date: 2024-09-04
Estimated Completion Date: 2030-07-30
Participants
Target number of participants: 180
Treatments
Active_comparator: risperidone
risperidone treatment provided per protocol
Active_comparator: aripiprazole
aripiprazole treatment per protocol
Active_comparator: clozapine
clozapine treatment per protocol
Related Therapeutic Areas
Sponsors
Collaborators: National Institute of Mental Health (NIMH)
Leads: Northwell Health

This content was sourced from clinicaltrials.gov

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