Electroconvulsive Therapy Treated PatientsNCT04763655
Neural Biomarkers of Electroconvulsive Therapy Response
A study testing clinical and neuropsychological testing in people with Electroconvulsive Therapy Treated Patients, run by Northwell Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Electroconvulsive Therapy Treated Patients
- What is being tested?
- clinical and neuropsychological testing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2020to 1 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
The Zucker Hillside Hospital
Glen Oaks, New York, 11004
Heela Azizi, 718-470-8165, hazizi1@northwell.edu
About this study
Official title: Neural Biomarkers of Electroconvulsive Therapy Response in Schizophrenia
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.
- Being tested
- clinical and neuropsychological testing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clinical and neuropsychological testingDiagnostic test
Also called MRI of the brain
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
| Study group | Role | What they receive |
|---|---|---|
| Treatment as usual | Other | Not described Receives: Diagnostic Test: clinical and neuropsychological testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Response to Brief Psychiatry Rating Scale (BPRS)
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.
Measured: Baseline and 8 weeks.
Secondary outcomes (3)
The change of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS)
Using the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) neuropsychology battery, the age corrected standardized total T-scores change will be reported.
Measured: Baseline and 8 weeks.
Volume change of the hippocampus bilaterally based on MRI based volumetry
Volume change in the hippocampus measured by subtracting the volume of the bilateral hippocampus at 8th week from baseline divided by baseline (percentage). A longitudinal FreeSurfer (MGH) will be used to measure the volumes of the hippocampus in cubic centimeters and the change will be reported.
Measured: Baseline and 8 weeks.
Magnitude of the electric field in the hippocampus bilaterally
The electrical field will be estimated with finite element modeling from the structural scans in the hippocampus (Volt per meter). A Matlab based program called ROAST (developed at CUNY) to estimate the electric field in the hippocampus and the average electric field magnitude across the hippocampus will be reported.
Measured: At baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start1 Apr 2020
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Electroconvulsive Therapy Treated PatientsStudies of the same condition, open and under way.
- More trials run by Northwell HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Miklos Argyelan, MD, Principal investigator, The Zucker Hillside Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04763655
- Sponsor's protocol ID
- 18-0100
- Other IDs
- K23MH120504
- Status last verified
- Sep 2024
- First submitted
- 18 Feb 2021
- Last updated
- 1 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data is shared via the National Institute of Mental Health Data Archive mechanisms.
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neural Biomarkers of Electroconvulsive Therapy Response in Schizophrenia
- ClinicalTrials.gov ID
- NCT04763655
- Acronym / sponsor ID
- 18-0100
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 21 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment as usual | Other | Diagnostic Test: clinical and neuropsychological testing |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| clinical and neuropsychological testingAlso: MRI of the brainPatients 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 | Diagnostic test | Treatment as usual |
Primary outcome
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.
3 secondary outcomes
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
- Individual participant dataSharing planned: Yes. Data is shared via the National Institute of Mental Health Data Archive mechanisms.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Miklos Argyelan, MD principal investigator
The Zucker Hillside Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing clinical and neuropsychological testing in people with Electroconvulsive Therapy Treated Patients, run by Northwell Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Heela Azizi (718-470-8165, hazizi1@northwell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Response to Brief Psychiatry Rating Scale (BPRS) (time frame: Baseline and 8 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2024.