Neural Biomarkers of Electroconvulsive Therapy Response in Schizophrenia

Who is this study for? Adult patients with Schizophrenia
Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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.

Locations
United States
New York
The Zucker Hillside Hospital
RECRUITING
Glen Oaks
Contact Information
Primary
Heela Azizi
hazizi1@northwell.edu
718-470-8165
Time Frame
Start Date: 2020-04-01
Estimated Completion Date: 2025-07-01
Participants
Target number of participants: 75
Treatments
Other: Treatment as usual
Related Therapeutic Areas
Sponsors
Collaborators: National Institutes of Health (NIH)
Leads: Northwell Health

This content was sourced from clinicaltrials.gov