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โ† Trials
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Biomarkers to Enhance Early Schizophrenia Treatment

RecruitingPhase 4Ages 18 Years - 35 YearsAllNorthwell Health
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ฅ4 (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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What it tests

  • aripiprazole
  • risperidone
  • clozapine
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Where

5 sites
The University of Alabama at Birmingham
Birmingham, United States
University of California San Diego
La Jolla, United States
McLean
Belmont, United States
Feinstein Institute for Medical Research
Glen Oaks, United States
Centre for Addiction and Mental Health
Toronto, Canada
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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