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RecruitingNot ApplicableNCT04763655

Neural Biomarkers of Electroconvulsive Therapy Response

Neural Biomarkers of Electroconvulsive Therapy Response in Schizophrenia

Sponsor

Northwell Health

Enrollment

75 participants

Start Date

Apr 1, 2020

Study Type

INTERVENTIONAL

Conditions

Electroconvulsive Therapy Treated Patients

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

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria5

  • current positive symptoms rated ≥4 (moderate) on one or more of these BPRS 53 items: hallucinatory behavior, unusual thought content, suspiciousness, conceptual disorganization;
  • has failed at least one trial of treatment with antipsychotic drug, lasting 6 weeks in duration,
  • competent and willing to sign informed consent;
  • for women, negative pregnancy test and agreement to use a medically accepted birth control method; and
  • Diagnostic and Statistical Manual (DSM)-IV diagnosis of schizophrenia, schizoaffective or schizophreniform disorder.

Exclusion Criteria6

  • 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 (MMSE ≤ 23) or language limitations that would preclude subjects providing informed consent;
  • contraindications to treatment with electroconvulsive therapy;
  • contraindications to magnetic resonance imaging (e.g. pacemaker)

Interventions

DIAGNOSTIC_TESTclinical and neuropsychological testing

Patients are monitored with Brief Psychiatric Rating Scale (BPRS) weekly and structural and functional MRI and MATRICS battery before and at the end of the course of the study

Locations(1)

The Zucker Hillside Hospital

Glen Oaks, New York, United States

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NCT04763655