Neural Biomarkers of Electroconvulsive Therapy Response

NCT04763655 | Recruiting

• 2 other identifiers: 18-0100K23MH120504
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Rate of Response to Brief Psychiatry Rating Scale (BPRS)

  The change of total BPRS score between Week 8 and Baseline divided by baseline (percentage change). The change in the total score which can be between 18-126 (in extreme cases) will be reported.

  Baseline and 8 weeks.

Secondary Outcomes (3)

• The change of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS)

  Baseline and 8 weeks.

• Volume change of the hippocampus bilaterally based on MRI based volumetry

  Baseline and 8 weeks.

• Magnitude of the electric field in the hippocampus bilaterally

  At baseline.

Study Arms (1)

Treatment as usual

OTHER

Diagnostic Test: clinical and neuropsychological testing

Interventions

clinical and neuropsychological testing 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

Also known as: MRI of the brain

Treatment as usual

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Northwell Health: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

The Zucker Hillside Hospital

Glen Oaks, New York, 11004, United States

RECRUITING

Study Officials

• Miklos Argyelan, MD

  The Zucker Hillside Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Heela Azizi

CONTACT

718-470-8165; hazizi1@northwell.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2021
• First Posted: February 21, 2021
• Study Start: April 1, 2020
• Primary Completion: December 1, 2024
• Study Completion: July 1, 2025
• Last Updated: October 1, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share

Locations

US (1)