Brain scans and genes may guide better schizophrenia drug choices
NCT ID NCT06969755
First seen Jun 26, 2026 · Last updated Jul 31, 2026 · Updated 2 times
Summary
This study is for people aged 18-35 experiencing their first episode of psychosis. Researchers will use genetic tests and MRI brain scans to see if certain markers can predict which antipsychotic drug (aripiprazole, risperidone, or clozapine) will work best. The goal is to improve symptom relief and reduce side effects like weight gain. Participants will be followed for 12 weeks to compare how well each drug works based on their individual biology.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- aripiprazole, risperidone, and clozapine (antipsychotic drugs)
- What this could lead to
- If successful, this could help doctors choose the right medication for early schizophrenia based on a patient's genetics and brain scans, leading to better symptom control and fewer side effects.
- What could go wrong
- This is a Phase 4 study with 180 participants, so results may not apply to everyone. The genetic and brain scan markers are still experimental, and the drugs have known risks like weight gain and blood cell problems.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 180 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2024
- Expected to finish
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Jul 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 35 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Aged 18 to 35. 2. DSM5 diagnosis (as determined by the SCID5) of schizophrenia, schizoaffective disorder, schizophreniform disorder. 3. 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. 4. Preserved striatal connectivity, as determined by screening MRI scan 5. Absence of the MC4R high-risk genotype, as determined by genetic testing 6. Absence of the HLA-DQB1 high-risk genotype, as determined by genetic testing 7. 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) 8. Ability to provide informed consent Exclusion Criteria: 1. 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 2. An abnormal EKG at screening that the investigator determines could interfere with the interpretation of the efficacy or safety measurements 3. Any medical condition which requires treatment with a medication with psychotropic effects. 4. 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). 5. Cognitive limitations, or any other factor that would preclude potential participants providing informed consent 6. Contraindications to MRI (e.g. pacemaker). 7. 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 8. 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) 9. Prior psychosurgery 10. Pregnancy (self-report) 11. Seizure disorder (self-report) \-
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
5 sites in 2 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Centre for Addiction and Mental Health
RECRUITINGToronto, Canada
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Feinstein Institute for Medical Research
RECRUITINGGlen Oaks, New York, 11004, United States
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McLean
RECRUITINGBelmont, Massachusetts, 02478, United States
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The University of Alabama at Birmingham
RECRUITINGBirmingham, Alabama, 35294, United States
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University of California San Diego
RECRUITINGLa Jolla, California, 92093, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Scientists probe brain's reward system in mental illness
- Can talk therapy and social coaching ease early psychosis?
- Brain training may reshape brain chemistry in schizophrenia
- Could a single daily dose of clozapine work just as well?
- A gentle brain zap might boost medication adherence in schizophrenia
- Can sound and light waves calm the mind in schizophrenia?