Mechanism of Action of Electroconvulsive Therapy (MoA-ECT)

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

Study Overview

• Status: Recruiting
• Conditions: Bipolar Depression; Unipolar Depression
• Intervention / Treatment: Device: Electroconvulsive Therapy

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 Type: Observational
• Enrollment (Estimated): 136

Contacts and Locations

• Study Contact: Name: DNN Inbox; Phone Number: 617-724-8780; Email: mghdnn@mgh.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02129
      • Recruiting
      • Massachusetts General Hospital
      • Contact: DNN Inbox; Phone Number: 617-724-8780; Email: mghdnn@mgh.harvard.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Male and Female Patients with Unipolar or Bipolar Depression Between the Ages of 18 and 65 Being Treated with ECT as Part of Outpatient Psychiatric Care, or Healthy Controls.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Unipolar Depression; Patients diagnosed with Major Depressive Disorder.	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.
Bipolar Depression; Patients diagnosed with Bipolar I or II.	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.
Healthy Control; Patients without psychiatric diagnoses.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Investigators: Principal Investigator: Joan Camprodon, MD MPH PHD, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 28, 2019
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: August 14, 2019
• First Submitted That Met QC Criteria: August 15, 2019
• First Posted (Actual): August 16, 2019

Study Record Updates

• Last Update Posted (Actual): March 22, 2024
• Last Update Submitted That Met QC Criteria: March 20, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Magnetic Resonance Imaging; Electroconvulsive Therapy
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Bipolar and Related Disorders; Depression; Depressive Disorder; Bipolar Disorder
• Other Study ID Numbers: 2012P001430

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All identifying information (e.g., name, medical record number, date of birth) will be removed from data that will be shared with other researchers or research databases. It will not be possible to link the information back to the participant.
• IPD Sharing Time Frame: Data will become available at study completion for an undefined amount of time.
• IPD Sharing Access Criteria: Data will be accessible by researchers who have access to research databases at the NIH.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No