Status:
RECRUITING
Neural Biomarkers of Electroconvulsive Therapy Response
Lead Sponsor:
Northwell Health
Collaborating Sponsors:
National Institutes of Health (NIH)
Conditions:
Electroconvulsive Therapy Treated Patients
Eligibility:
All Genders
18-80 years
Phase:
NA
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 n...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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)
Key Trial Info
Start Date :
April 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2025
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT04763655
Start Date
April 1 2020
End Date
July 1 2025
Last Update
October 1 2024
Active Locations (1)
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1
The Zucker Hillside Hospital
Glen Oaks, New York, United States, 11004