Mechanism of Action of Electroconvulsive Therapy

NCT04059952 | Completed FDA Device

• 1 other identifier: 2012P001430
• Study Type: observational
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Unipolar Depression; Bipolar Depression

Keywords

Electroconvulsive Therapy; Magnetic Resonance Imaging

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Changes in Functional Connectivity of Memory Circuits

  Through Treatment Completion, Average of 2 Months

Study Arms (3)

Unipolar Depression

Patients diagnosed with Major Depressive Disorder.

Device: Electroconvulsive Therapy

Bipolar Depression

Patients diagnosed with Bipolar I or II.

Device: Electroconvulsive Therapy

Healthy Control

Patients without psychiatric diagnoses.

Interventions

Electroconvulsive Therapy DEVICE

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; Unipolar Depression

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02129, United States

Location

MeSH Terms

Conditions

Depressive Disorder; Bipolar Disorder

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders; Bipolar and Related Disorders

Study Officials

• Joan Camprodon, MD MPH PHD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Division of Neuropsychiatry, Director of TMS Clinic, Director of Lab for Neuropsychiatry and Neuromodulation

Study Record Dates

• First Submitted: August 14, 2019
• First Posted: August 16, 2019
• Study Start: June 28, 2019
• Primary Completion: May 31, 2024
• Study Completion: May 31, 2024
• Last Updated: June 12, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will become available at study completion for an undefined amount of time.
• Access Criteria: Data will be accessible by researchers who have access to research databases at the NIH.

Locations

US (1)