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RecruitingPhase 4

Biomarkers to Enhance Early Schizophrenia Treatment

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 35 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at whether certain genetic factors may help find medicines that work better for people with psychosis. Psychosis can cause unusual beliefs or seeing or hearing things that are not there. The study is for adults ages 18 to 35 who are having their first episode.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are 18 to 35 years old.
  • A study interview confirms schizophrenia, schizoaffective disorder, or schizophreniform disorder—conditions that cause psychosis.
  • You have at least one symptom rated moderate or worse: unusual thoughts, confused thinking, seeing or hearing things that are not there, or strong distrust of others.
  • A screening MRI brain scan shows that connections in a brain area called the striatum are preserved.
  • Genetic testing shows you do not have the high-risk form of the MC4R gene.
  • Genetic testing shows you do not have the high-risk form of the HLA-DQB1 gene.
  • You have taken medicines for psychosis for a total of 4 weeks or less in your life. Very low doses used for other reasons, such as sleep, may not count.
  • You can understand the study and agree to take part.

Who can't join

  • You have a serious nerve, brain, or hormone disorder, or an abnormal heart tracing (EKG), that the study doctor thinks could affect how results are understood.
  • You have a health condition that needs medicine that affects your thoughts, mood, or behavior.
  • Study checks show a serious risk that you may harm yourself or someone else.
  • Problems with thinking or another issue prevent you from agreeing to take part, or screening suggests an intellectual disability, including an IQ score below 71.
  • You cannot safely have an MRI scan, for example because you have a pacemaker.
  • Within 3 months of screening, you have a moderate or severe substance use disorder, except nicotine, or a mild one involving substances other than cannabis, alcohol, or nicotine. A positive starting urine test for drugs other than those three also rules you out.
  • You have had brain surgery to treat a mental health condition.
  • You report being pregnant or having a seizure disorder.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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) \-

Study sites (4)

AL

CA

MA

NY