Biomarkers to Enhance Early Schizophrenia Treatment
Key facts
- Where
- Toronto, CanadaSee the site
- Phase
- Phase 4
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 35 years old?
Source: NCT06969755, who can take part
Where in Canada
- Centre for Addiction and Mental HealthToronto, CanadaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Northwell Health
- Trial code
- NCT06969755
- Record updated
- 31 July 2026
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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.
Exclusion: Any medical condition which requires treatment with a medication with psychotropic effects; 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; Prior psychosurgery; 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; Seizure disorder (self-report); -; An abnormal EKG at screening that the investigator determines could interfere with the interpretation of the efficacy or safety measurements; 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); Cognitive limitations, or any other factor that would preclude potential participants providing informed consent; Contraindications to MRI (e.g. pacemaker); 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); Pregnancy (self-report).