Health TrialsbyHealthPanel

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • aripiprazole

    Drug

    aripiprazole arm (titrated dose)

  • risperidone

    Drug

    risperidone arm (titrated dose)

  • clozapine

    Drug

    clozapine (titrated dose)

Treatment groups

180 Participants
are divided into 3 treatment groups
Group A: risperidoneActive comparator 1 intervention
Group B: aripiprazoleActive comparator 1 intervention
Group C: clozapineActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Total change in BPRS Symptoms

To compare the 12-week response rate of CLZ versus FL-APs (both risperidone and aripiprazole) utilizing the BPRS

Time frame
12 weeks

Secondary outcomes

1

Weight Gain

To compare weight gain associated with 12 weeks of treatment with CLZ vs. FL-APs in 3B+ FEP patients.

Time frame
12 weeks
2

Agranulocytosis

To compare rates of agranulocytosis in 3B+ FEP patients treated for 12 weeks with CLZ vs. 3B+ FEP patients treated with FL-APs

Time frame
12 weeks
3

Neutropenia

To compare rates of neutropenia in 3B+ FEP patients treated for 12 weeks with CLZ vs. 3B+ FEP patients treated with FL-APs

Time frame
12 weeks

Other outcomes

1

Functional MRI

Evaluate changes in resting-state functional connectivity patterns related to CLZ response by comparing baseline to 12-week rs-fMRI scans

Time frame
12 weeks
2

Functional Outcome

To explore the days in hospital of CLZ-treated 3B+ FEP patients vs. 3B+ FEP patients treated with FL-

Time frame
12 weeks
3

Functional Outcome

To explore suicidal ideation of CLZ-treated 3B+ FEP patients vs. 3B+ FEP patients treated with FL-APs as measured by the CSSRS

Time frame
12 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Northwell Health

Lead sponsor

National Institute of Mental Health (NIMH)

Collaborator

Source ClinicalTrials.gov
Apply now