Neural Biomarkers of Electroconvulsive Therapy Response

Electroconvulsive Therapy Treated Patients Clinical Trial

Official title:

Neural Biomarkers of Electroconvulsive Therapy Response in Schizophrenia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04763655
• Other study ID #: 18-0100
• Secondary ID: K23MH120504
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2020
• Est. completion date: July 1, 2025

Study information

• Verified date: March 2023
• Source: Northwell Health
• Contact: Heela Azizi
• Phone: 718-470-8165
• Email: hazizi1[@]northwell.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: July 1, 2025
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Electroconvulsive Therapy Treated Patients

Intervention

Diagnostic Test:
• 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

Locations

Country	Name	City	State
United States	The Zucker Hillside Hospital	Glen Oaks	New York

Sponsors (2)

Lead Sponsor	Collaborator
Northwell Health	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The change of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS)	Using the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) neuropsychology battery, the age corrected standardized total T-scores change will be reported.	Baseline and 8 weeks.
Secondary	Volume change of the hippocampus bilaterally based on MRI based volumetry	Volume change in the hippocampus measured by subtracting the volume of the bilateral hippocampus at 8th week from baseline divided by baseline (percentage). A longitudinal FreeSurfer (MGH) will be used to measure the volumes of the hippocampus in cubic centimeters and the change will be reported.	Baseline and 8 weeks.
Secondary	Magnitude of the electric field in the hippocampus bilaterally	The electrical field will be estimated with finite element modeling from the structural scans in the hippocampus (Volt per meter). A Matlab based program called ROAST (developed at CUNY) to estimate the electric field in the hippocampus and the average electric field magnitude across the hippocampus will be reported.	At baseline.