Investigating brain changes in patients receiving electroconvulsive therapy
Neural Biomarkers of Electroconvulsive Therapy Response in Schizophrenia
NA · Northwell Health · NCT04763655
This study is testing how electroconvulsive therapy affects the brains of people with schizophrenia over eight weeks to see if it helps improve their symptoms.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 75 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Northwell Health (other) |
| Locations | 1 site (Glen Oaks, New York) |
| Trial ID | NCT04763655 on ClinicalTrials.gov |
What this trial studies
This study aims to explore the neural effects of electroconvulsive therapy (ECT) on patients diagnosed with schizophrenia and related disorders. Utilizing resting-state functional MRI and structural MRI-based electrical field modeling, the researchers will track changes in brain circuitry over an 8-week treatment period. A total of 75 patients beginning bilateral ECT will be recruited, and their clinical and cognitive performance will be assessed at baseline and after 8 weeks. The study employs a longitudinal design to better understand the relationship between ECT and neural biomarkers.
Who should consider this trial
Good fit: Ideal candidates include individuals with a DSM-IV diagnosis of schizophrenia, schizoaffective, or schizophreniform disorder who are starting ECT and have not responded to prior antipsychotic treatments.
Not a fit: Patients with serious neurological disorders, significant cognitive impairments, or contraindications to ECT may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding of how ECT affects brain function, potentially enhancing treatment strategies for patients with severe psychiatric disorders.
How similar studies have performed: While there is ongoing research into the effects of ECT, this specific approach utilizing advanced imaging techniques is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. current positive symptoms rated ≥4 (moderate) on one or more of these BPRS 53 items: hallucinatory behavior, unusual thought content, suspiciousness, conceptual disorganization; 2. has failed at least one trial of treatment with antipsychotic drug, lasting 6 weeks in duration, 3. competent and willing to sign informed consent; 4. for women, negative pregnancy test and agreement to use a medically accepted birth control method; and 5. Diagnostic and Statistical Manual (DSM)-IV diagnosis of schizophrenia, schizoaffective or schizophreniform disorder. Exclusion Criteria: 1. serious neurological or endocrine disorder; 2. any medical condition which requires treatment with a medication with psychotropic effects; 3. significant risk of suicidal or homicidal behavior; 4. cognitive (MMSE ≤ 23) or language limitations that would preclude subjects providing informed consent; 5. contraindications to treatment with electroconvulsive therapy; 6. contraindications to magnetic resonance imaging (e.g. pacemaker)
Where this trial is running
Glen Oaks, New York
- The Zucker Hillside Hospital — Glen Oaks, New York, United States (RECRUITING)
Study contacts
- Principal investigator: Miklos Argyelan, MD — The Zucker Hillside Hospital
- Study coordinator: Heela Azizi
- Email: hazizi1@northwell.edu
- Phone: 718-470-8165
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Electroconvulsive Therapy Treated Patients