Neural Biomarkers of Electroconvulsive Therapy Response in Schizophrenia
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Electroconvulsive Therapy Treated Patients
- Sponsor
- Northwell Health
- Enrollment
- 75
- Locations
- 1
- Primary Endpoint
- Rate of Response to Brief Psychiatry Rating Scale (BPRS)
- Status
- Recruiting
- Last Updated
- last year
Overview
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 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.
Investigators
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)
Outcomes
Primary Outcomes
Rate of Response to Brief Psychiatry Rating Scale (BPRS)
Time Frame: Baseline and 8 weeks.
The change of total BPRS score between Week 8 and Baseline divided by baseline (percentage change). The change in the total score which can be between 18-126 (in extreme cases) will be reported.
Secondary Outcomes
- The change of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS)(Baseline and 8 weeks.)
- Volume change of the hippocampus bilaterally based on MRI based volumetry(Baseline and 8 weeks.)
- Magnitude of the electric field in the hippocampus bilaterally(At baseline.)