Actively Recruiting
Neural Biomarkers of Electroconvulsive Therapy Response in Schizophrenia
Led by Northwell Health · Updated on 2024-10-01
75
Participants Needed
1
Research Sites
30 weeks
Total Duration
On this page
Sponsors
N
Northwell Health
Lead Sponsor
N
National Institutes of Health (NIH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating the effects of electroconvulsive therapy (ECT) on the brain's neural circuitry in patients with schizophrenia and related disorders. This study focuses on patients starting bilateral ECT treatment and aims to understand how their clinical symptoms and cognitive performance change over an 8-week treatment period. The study uses advanced brain imaging techniques, including resting-state functional MRI and structural MRI-based electrical field modeling, to explore these effects. Participants will undergo clinical and neuropsychological testing throughout the study. They will be monitored weekly using the Brief Psychiatric Rating Scale (BPRS) and will have MRI scans and cognitive testing with the MATRICS battery at the start and end of the 8-week treatment. The primary focus is on the rate of clinical response as measured by changes in BPRS scores. Secondary outcomes include changes in cognitive function, hippocampal volume, and the magnitude of electric fields in the hippocampus. During the study, participants will be followed longitudinally through their clinical ECT treatment, with assessments at baseline and after 8 weeks. Researchers will collect imaging data and cognitive test results to assess treatment effects. The study will monitor safety and clinical progress, aiming to better understand the neural biomarkers related to ECT response in schizophrenia. Total participation spans the initial treatment course of 8 weeks.
CONDITIONS
Brief Title
Neural Biomarkers of Electroconvulsive Therapy Response
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Current positive symptoms rated 4 (moderate) or higher on hallucinatory behavior, unusual thought content, suspiciousness, or conceptual disorganization
- Has failed at least one trial of antipsychotic drug treatment lasting 6 weeks
- Competent and willing to sign informed consent
- For women, negative pregnancy test and agreement to use medically accepted birth control
- Diagnosis of schizophrenia, schizoaffective, or schizophreniform disorder according to DSM-IV
You will not qualify if you...
- Serious neurological or endocrine disorder
- Medical conditions requiring treatment with medications that have psychotropic effects
- Significant risk of suicidal or homicidal behavior
- Cognitive impairment (MMSE score 23 or less) or language limitations preventing informed consent
- Contraindications to electroconvulsive therapy
- Contraindications to magnetic resonance imaging, such as having a pacemaker
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 8 weeks
Participants receive electroconvulsive therapy while being monitored with weekly psychiatric rating scales and undergo MRI and cognitive testing before and after the treatment course.
Weekly visits for clinical assessments; 2 MRI and cognitive testing visits (before and after treatment)
Trial Site Locations
Total: 1 location
1
The Zucker Hillside Hospital
Glen Oaks, New York, United States, 11004
Actively Recruiting
Research Team
H
Heela Azizi
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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