Neural Biomarkers of Electroconvulsive Therapy Response

Northwell Health

Status: Enrolling

Conditions: Electroconvulsive Therapy Treated Patients

Treatments: Diagnostic Test: clinical and neuropsychological testing

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04763655

18-0100

K23MH120504

Details and patient eligibility

About

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.

Enrollment: 75 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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75 participants in 1 patient group

Treatment as usual

Other group

Treatment:

Diagnostic Test: clinical and neuropsychological testing