Aripiprazole, Risperidone, and Clozapine for Schizophrenia
(BEEST Trial)
PM
CG
Overseen ByCristina Gonzalez
Age: 18 - 65
Sex: Any
Trial Phase: Phase 4
Sponsor: Northwell Health
Must be taking: Antipsychotics
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Trial Summary
What is the purpose of this trial?
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 Criteria
This trial is for individuals aged 18 to 35 experiencing their first episode of psychosis, with specific genetic markers and preserved brain connectivity. They must have taken antipsychotic drugs for no more than 4 weeks and be able to consent. Exclusions include serious neurological/endocrine disorders, MRI contraindications, pregnancy, high suicide risk, intellectual disability (IQ <71), recent substance abuse (except nicotine or mild alcohol/cannabis use), psychotropic medication need, prior psychosurgery or seizure disorder.Inclusion Criteria
Preserved striatal connectivity, as determined by screening MRI scan
Ability to provide informed consent
I do not have the high-risk MC4R gene variant.
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Exclusion Criteria
I have a serious brain or hormone disorder that could affect study results.
Contraindications to MRI (e.g. pacemaker)
I am able to understand and give consent for my participation.
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Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
1 visit (in-person)
Treatment
Participants receive treatment with either clozapine or FL-APs (risperidone or aripiprazole) for 12 weeks
12 weeks
Regular visits as per protocol
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
2 visits (in-person)
Treatment Details
Interventions
- Aripiprazole
- Clozapine
- Risperidone
Trial Overview The study tests how well participants with early schizophrenia respond to aripiprazole, risperidone or clozapine based on their genetic makeup. It aims to identify biomarkers that predict better treatment outcomes in those newly diagnosed with psychosis.
Participant Groups
3Treatment groups
Active Control
Group I: risperidoneActive Control1 Intervention
risperidone treatment provided per protocol
Group II: clozapineActive Control1 Intervention
clozapine treatment per protocol
Group III: aripiprazoleActive Control1 Intervention
aripiprazole treatment per protocol
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Who Is Running the Clinical Trial?
Northwell Health
Lead Sponsor
Trials
481
Recruited
470,000+
National Institute of Mental Health (NIMH)
Collaborator
Trials
3,007
Recruited
2,852,000+
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