Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
ID04763655

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

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

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

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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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