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NCT04763655NARecruiting

Neural Biomarkers of Electroconvulsive Therapy Response

Northwell Health

Start Date

4/1/2020

Completion Date

7/1/2025

Summary

In the proposed study, the investigators will utilize resting-state functional MRI (fMRI) and structural MRI-based electrical field modeling to study the effect of electroconvulsive therapy on human neural circuitry. Our study will recruit patients who are beginning treatment with bilateral electroconvulsive therapy (N=75). Our design will be longitudinal where patients will be followed up until their 8th week electroconvulsive therapy clinically. The primary measure of interest will be the slope of clinical change estimated with mixed effect modeling (see Approach). Secondary measures will be the cognitive performance change between baseline and the 8th week electroconvulsive therapy time point.

Eligibility Criteria

Age Range: 18 years to 80 years

Inclusion Criteria: 1. current positive symptoms rated ≥4 (moderate) on one or more of these BPRS 53 items: hallucinatory behavior, unusual thought content, suspiciousness, conceptual disorganization; 2. has failed at least one trial of treatment with antipsychotic drug, lasting 6 weeks in duration, 3. competent and willing to sign informed consent; 4. for women, negative pregnancy test and agreement to use a medically accepted birth control method; and 5. Diagnostic and Statistical Manual (DSM)-IV diagnosis of schizophrenia, schizoaffective or schizophreniform disorder. Exclusion Criteria: 1. serious neurological or endocrine disorder; 2. any medical condition which requires treatment with a medication with psychotropic effects; 3. significant risk of suicidal or homicidal behavior; 4. cognitive (MMSE ≤ 23) or language limitations that would preclude subjects providing informed consent; 5. contraindications to treatment with electroconvulsive therapy; 6. contraindications to magnetic resonance imaging (e.g. pacemaker)

Interventions

DIAGNOSTIC_TEST

clinical and neuropsychological testing

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Conditions

Electroconvulsive Therapy Treated Patients

Locations

The Zucker Hillside Hospital

Glen Oaks, New York 11004

United States