Mechanism of Action of Electroconvulsive Therapy

Recruiting

• Conditions: Unipolar Depression; Bipolar Depression
• Interventions: Device: Electroconvulsive Therapy

• Registration Number: NCT04059952
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2019-06-28
• Study First Submitted: 2019-08-14
• Study First Submitted QC: 2019-08-15
• Study First Posted: 2019-08-16
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-20
• Last Update Posted: 2024-03-22
• Primary Completion: 2024-06-01
• Study Completion: 2024-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 136

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Unipolar Depression	Electroconvulsive Therapy	Patients diagnosed with Major Depressive Disorder.
Bipolar Depression	Electroconvulsive Therapy	Patients diagnosed with Bipolar I or II.

Primary Outcome Measures

Name	Time	Method
Changes in Functional Connectivity of Key Nodes	Through Treatment Completion, Average of 2 Months	Measured by Magnetic Resonance Imaging, Key Nodes include Subgenual Cingulate, Dorsal Anterior Cingulate, Nucleus Accumbens, Hippocampus, Amygdala and Dorsolateral Prefrontal Cortex

Secondary Outcome Measures

Name	Time	Method
Changes in Functional Connectivity of Memory Circuits	Through Treatment Completion, Average of 2 Months	Measured by Magnetic Resonance Imaging, Memory Circuits Include Hippocampus and Dorsolateral Prefrontal Memory Hubs

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States