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Electroconvulsive Therapy for Mental Illness

N/A
Recruiting
Led By Miklos Argyelan, MD
Research Sponsored by Northwell Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnostic and Statistical Manual (DSM)-IV diagnosis of schizophrenia, schizoaffective or schizophreniform disorder
Current positive symptoms rated ≥4 (moderate) on one or more of these BPRS 53 items: hallucinatory behavior, unusual thought content, suspiciousness, conceptual disorganization
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 8 weeks.
Awards & highlights

Study Summary

This trial will study the effects of electroconvulsive therapy on human neural circuitry, with the goal of understanding how it may help treat mental illness.

Who is the study for?
This trial is for patients with moderate to severe symptoms of schizophrenia, schizoaffective, or schizophreniform disorder who haven't responded well to at least one antipsychotic drug treatment. Participants must be able to consent and women must use birth control. People with cognitive impairments, MRI contraindications, serious neurological/endocrine disorders, psychotropic medication needs, or significant suicide/homicide risk are excluded.Check my eligibility
What is being tested?
The study tests how electroconvulsive therapy (ECT) affects brain circuitry in patients using fMRI and structural MRI-based electrical field modeling. It's a longitudinal study where changes in clinical condition and cognitive performance from baseline until the 8th week of ECT will be measured.See study design
What are the potential side effects?
While not explicitly listed here, common side effects of ECT can include confusion immediately after treatment, memory loss for events surrounding the period of ECT treatment, physical side effects such as headache, muscle soreness or nausea.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with schizophrenia or a related disorder.
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I experience moderate to severe symptoms like hallucinations or unusual thoughts.
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I have tried an antipsychotic medication for 6 weeks without success.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at baseline.
This trial's timeline: 3 weeks for screening, Varies for treatment, and at baseline. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Rate of Response to Brief Psychiatry Rating Scale (BPRS)
Secondary outcome measures
Magnitude of the electric field in the hippocampus bilaterally
The change of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS)
Volume change of the hippocampus bilaterally based on MRI based volumetry

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment as usualExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

Northwell HealthLead Sponsor
458 Previous Clinical Trials
470,858 Total Patients Enrolled
National Institute of Mental Health (NIMH)NIH
2,784 Previous Clinical Trials
2,689,202 Total Patients Enrolled
Miklos Argyelan, MDPrincipal InvestigatorThe Zucker Hillside Hospital
2 Previous Clinical Trials
23 Total Patients Enrolled

Media Library

Treatment as usual Clinical Trial Eligibility Overview. Trial Name: NCT04763655 — N/A
Electroconvulsive Therapy Research Study Groups: Treatment as usual
Electroconvulsive Therapy Clinical Trial 2023: Treatment as usual Highlights & Side Effects. Trial Name: NCT04763655 — N/A
Treatment as usual 2023 Treatment Timeline for Medical Study. Trial Name: NCT04763655 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the size of this research project's participant pool?

"Indeed, the information on clinicaltrials.gov reveals that this medical experiment is looking for volunteers. It was originally posted on April 1st 2020 and its parameters were last adjusted on February 23rd 2021. This trial requires 75 individuals to be recruited from one location."

Answered by AI

Do I meet the requirements to participate in this scientific experiment?

"In order to be accepted into this study, individuals must have undergone electroconvulsive therapy and must fall within the age range of 18-80. Approximately 75 participants are being sought for inclusion in the trial."

Answered by AI

Is eligibility for this investigation restricted to those under 40 years old?

"An individual must be at least 18 and no more than 80 years old in order to meet the qualifications for this clinical trial."

Answered by AI

Are there still opportunities to join this research endeavor?

"Affirmative. Clinicaltrials.gov demonstrates that this clinical trial is currently recruiting participants, with a first posting date of April 1st 2020 and most recent update on February 23rd 2021. It requires finding 75 patients to participate at the single specified location."

Answered by AI
~9 spots leftby Dec 2024