Mechanism of Action of Electroconvulsive Therapy

Bipolar Depression Clinical Trial

— MoA-ECT  

Official title:

Mechanism of Action of Electroconvulsive Therapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04059952
• Other study ID #: 2012P001430
• Status: Recruiting
• Start date: June 28, 2019
• Est. completion date: December 1, 2024

Study information

• Verified date: March 2024
• Source: Massachusetts General Hospital
• Contact: DNN Inbox
• Phone: 617-724-8780
• Email: mghdnn[@]mgh.harvard.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is an observational neuroimaging study assessing the effects of ECT on the brains of patients with unipolar and bipolar depression.

Description:

This project aims to use functional connectivity magnetic resonance imaging (fcMRI) to study patients with unipolar and bipolar depression receiving ECT. Patients will be scanned before and after a full course of ECT and clinical measures for depression severity and memory will be obtained at the same times.The project has the following aims and hypothesis: (1) to determine the therapeutic antidepressant mechanism of action of ECT at the circuit level (2) to determine the mechanism of action of iatrogenic amnesia caused by ECT at the circuit level (3) to study the use of fcMRI as a state biomarker for depression (4) to study the use of fcMRI as a predictor of response for depression.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 136
• Est. completion date: December 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Males and Females Between Ages of 18 and 65

• Diagnosis of Major Depressive Disorder without Psychotic Features or Bipolar I/II

• Requiring ECT Treatment as Part of Psychiatric Care

Exclusion Criteria:

• Comorbid diagnoses of Major Depressive Disorder with Psychotic Features, Schizoaffective Disorder, Schizophrenia or Dementia

• History of Psychosis

• Substance Use Disorder (Abuse or Dependence) with Active Use Within Last 6 Months

• Severe or Unstable Medical Illness

• Medical Contraindication to Anesthesia or ECT (e.g., Recent Myocardial Infarction)

Related Conditions & MeSH terms

• Bipolar Depression
• Bipolar Disorder
• Depression
• Depressive Disorder
• Unipolar Depression

Intervention

Device:
• Electroconvulsive Therapy
Electrical currents are passed through the brain to intentionally trigger a controlled seizure in order to produce a therapeutic change in neuro-chemistry and circuitry.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Functional Connectivity of Key Nodes	Measured by Magnetic Resonance Imaging, Key Nodes include Subgenual Cingulate, Dorsal Anterior Cingulate, Nucleus Accumbens, Hippocampus, Amygdala and Dorsolateral Prefrontal Cortex	Through Treatment Completion, Average of 2 Months
Secondary	Changes in Functional Connectivity of Memory Circuits	Measured by Magnetic Resonance Imaging, Memory Circuits Include Hippocampus and Dorsolateral Prefrontal Memory Hubs	Through Treatment Completion, Average of 2 Months