Neural Biomarkers of Electroconvulsive Therapy Response
Recruiting now · Not applicable
Conditions studied: Electroconvulsive Therapy Treated Patients
In brief
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.
Key facts
- Study ID
- NCT04763655
- Run by
- Northwell Health
- People needed
- 75
- Starts
- 2020-04-01
- Expected to finish
- 2025-07-01
- Last updated by the study team
- 2024-10-01
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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)
Where it is running
- The Zucker Hillside Hospital — Glen Oaks, New York, United States (enrolling)
Full record on ClinicalTrials.gov
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