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Clinical Trials/NCT04059952
NCT04059952CompletedNot Applicable

Mechanism of Action of Electroconvulsive Therapy

Massachusetts General Hospital1 site in 1 country102 target enrollmentStarted: June 28, 2019Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
102
Locations
1
Primary Endpoint
Changes in Functional Connectivity of Key Nodes

Study Overview

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 Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
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)

Outcomes

Primary Outcomes

Changes in Functional Connectivity of Key Nodes

Time Frame: 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 Outcomes

  • Changes in Functional Connectivity of Memory Circuits(Through Treatment Completion, Average of 2 Months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

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

Study Sites (1)

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