Neural Biomarkers of Electroconvulsive Therapy Response

NCT ID: NCT04763655

Last Updated: 2024-10-01

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-04-01
• Study Completion Date: 2025-07-01

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 Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment as usual

Group Type: OTHER

clinical and neuropsychological testing

Intervention Type: DIAGNOSTIC_TEST

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

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

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

MRI of the brain

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

Northwell Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Miklos Argyelan, MD

Role: PRINCIPAL_INVESTIGATOR

The Zucker Hillside Hospital

Locations

The Zucker Hillside Hospital

Glen Oaks, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Heela Azizi

Role: CONTACT

hazizi1@northwell.edu

718-470-8165

Facility Contacts

Heela Azizi

Role: primary

hazizi1@northwell.edu

718-470-8165

Other Identifiers

K23MH120504

Identifier Type: NIH

Identifier Source: secondary_id

View Link

18-0100

Identifier Type: -

Identifier Source: org_study_id