NCT06969755 Biomarkers to Enhance Early Schizophrenia Treatment
| NCT ID | NCT06969755 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Northwell Health |
| Condition | Schizophenia Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 180 participants |
| Start Date | 2024-09-04 |
| Primary Completion | 2030-07-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 180 participants in total. It began in 2024-09-04 with a primary completion date of 2030-07-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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) \-
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06969755 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 35 Years, studying Schizophenia Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06969755 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06969755 currently recruiting?
Yes, NCT06969755 is actively recruiting participants. Contact the research team at pmarcy@northwell.edu for enrollment information.
Where is the NCT06969755 trial being conducted?
This trial is being conducted at Birmingham, United States, La Jolla, United States, Belmont, United States, Glen Oaks, United States and 1 additional location.
Who is sponsoring the NCT06969755 clinical trial?
NCT06969755 is sponsored by Northwell Health. The trial plans to enroll 180 participants.