MoA-ECT: Mechanism of Action of Electroconvulsive Therapy

Sponsor

Massachusetts General Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT04059952

Collaborator

(none)

136

Enrollment

Location

53.1

Anticipated Duration (Months)

2.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Unipolar Depression Bipolar Depression	Procedure: 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 Design

Study Type:

Observational

Anticipated Enrollment :

136 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Mechanism of Action of Electroconvulsive Therapy

Actual Study Start Date :

Jun 28, 2019

Anticipated Primary Completion Date :

Jun 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Unipolar Depression Patients diagnosed with Major Depressive Disorder.	Procedure: 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.	Procedure: 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.

Arm

Intervention/Treatment

Unipolar Depression

Patients diagnosed with Major Depressive Disorder.

Procedure: 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.

Procedure: 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.

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Massachusetts General Hospital	Boston	Massachusetts	United States	02129

Sponsors and Collaborators

Massachusetts General Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Joan A Camprodon, MD MPH PhD, Chief of Division of Neuropsychiatry, Director of TMS Clinic, Director of Lab for Neuropsychiatry and Neuromodulation, Massachusetts General Hospital

ClinicalTrials.gov Identifier:

NCT04059952

Other Study ID Numbers:

2012P001430

First Posted:

Aug 16, 2019

Last Update Posted:

Jul 22, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Keywords provided by Joan A Camprodon, MD MPH PhD, Chief of Division of Neuropsychiatry, Director of TMS Clinic, Director of Lab for Neuropsychiatry and Neuromodulation, Massachusetts General Hospital

Electroconvulsive Therapy

Magnetic Resonance Imaging

Additional relevant MeSH terms:

Depression

Depressive Disorder

Bipolar Disorder

Study Results

No Results Posted as of Jul 22, 2022