Neural Biomarkers of Electroconvulsive Therapy Response
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: clinical and neuropsychological testing.
- Who it may be relevant to
- Registry conditions: Electroconvulsive Therapy Treated Patients. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Neural Biomarkers of Electroconvulsive Therapy Response in Schizophrenia
Overview
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.
Interventions
- Diagnostic test clinical and neuropsychological testing
Patients are monitored with Brief Psychiatric Rating Scale (BPRS) weekly and structural and functional MRI and MATRICS battery before and at the end of the course of the study
Primary outcome measures
- Rate of Response to Brief Psychiatry Rating Scale (BPRS) [Time frame: Baseline and 8 weeks.]
Secondary outcome measures (3)
- The change of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) [Time frame: Baseline and 8 weeks.]
- Volume change of the hippocampus bilaterally based on MRI based volumetry [Time frame: Baseline and 8 weeks.]
- Magnitude of the electric field in the hippocampus bilaterally [Time frame: At baseline.]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- The Zucker Hillside Hospital — Glen Oaks
Identifiers
NCT: NCT04763655 · 18-0100 · K23MH120504