Biomarkers to Enhance Early Schizophrenia Treatment
ConditionSchizophenia Disorder
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-35
SponsorNorthwell Health
About this trial
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
Qualifiers
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
Disqualifiers
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
An abnormal EKG at screening that the investigator determines could interfere with the interpretation of the efficacy or safety measurements
Any medical condition which requires treatment with a medication with psychotropic effects.
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).
Trial design
Treatments tested in this trial
- aripiprazole
- risperidone
- clozapine
Treatment groups
180 Participants
are divided into 3 treatment groupsSponsors and collaborators
Northwell Health
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator
Source ClinicalTrials.gov