Neural Biomarkers of Clozapine Response (NCT03076346) | Clinical Trial Compass
CompletedNot Applicable
Neural Biomarkers of Clozapine Response
United States41 participantsStarted 2017-09-01
Plain-language summary
Clozapine has consistently shown to be a superior drug for psychosis in patients who do not respond to other treatments, but its mechanism of action remains unknown. The overall goal of this study is to examine the functional neural circuitry that underlies successful treatment with clozapine, which may lead to the identification of biomarkers that will allow for more efficient use of clozapine, as well as additional treatment targets for patients with refractory illness.
Who can participate
Age range18 Years – 50 Years
SexALL
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Inclusion criteria
✓. Current positive symptoms rated ≥4 (moderate) on one or more of these Brief Psychiatric Rating Scale items: hallucinatory behavior, unusual thought content and conceptual disorganization.
✓. Patient has failed two trials of treatment with antipsychotic drugs and the patient's clinical team is initiating clozapine.
✓. Age of 18 to 50.
✓. Patient is competent and willing to sign informed consent.
✓. For female patients, negative pregnancy test and agreement to use a medically accepted birth control method.
✓. Diagnosis of schizophrenia or schizoaffective disorder
Exclusion criteria
✕. Serious neurological or endocrine disorder.
✕. Any medical condition which requires treatment with a medication with psychotropic effects
✕. Significant risk of suicidal or homicidal behavior
✕. Cognitive or language limitations, or any other factor that would preclude subjects providing informed consent
✕. Contraindications to treatment with clozapine (e.g. failed response in past, or history of adverse reactions to treatment).
✕. Contraindications to magnetic resonance imaging (e.g. pacemaker).
What they're measuring
1
Changes in resting state functional connectivity with efficacious clozapine treatment