Recruiting

Electroconvulsive Therapy

Sponsor:

Northwell Health

Code:

NCT04763655

Conditions

Electroconvulsive Therapy Treated Patients

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

clinical and neuropsychological testing

Study Details

Brief 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.

Conditions

Electroconvulsive Therapy Treated Patients

Study ID

NCT04763655

Start date

Apr 1, 2020

Status verified date

Sep, 2024

Completion date

Jul 1, 2025

Anticipated

Primary completion date

Dec 1, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

75 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Treatment as usual

Interventions

clinical 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

Primary outcome measure

  • Rate of Response to Brief Psychiatry Rating Scale (BPRS) [ Time Frame: Baseline and 8 weeks. ]

Central Contacts and Locations

Central contacts

Locations

The Zucker Hillside Hospital

Recruiting

Glen Oaks, New York, United States, 11004

Contacts

More Information

Sponsor

Northwell Health

Last update posted

Oct 1, 2024

Last verified

Sep, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Northwell Health on 2024-10-01.