Mechanism of Action of Electroconvulsive Therapy

NCT ID: NCT04059952

Last Updated: 2025-06-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

102 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-06-28

Study Completion Date

2024-05-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Unipolar Depression Bipolar Depression

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Unipolar Depression

Patients diagnosed with Major Depressive Disorder.

Electroconvulsive Therapy

Intervention Type 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

Patients diagnosed with Bipolar I or II.

Electroconvulsive Therapy

Intervention Type 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.

Healthy Control

Patients without psychiatric diagnoses.

No interventions assigned to this group

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Joan A Camprodon, MD MPH PhD

Chief of Division of Neuropsychiatry, Director of TMS Clinic, Director of Lab for Neuropsychiatry and Neuromodulation

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Joan Camprodon, MD MPH PHD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

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Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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2012P001430

Identifier Type: -

Identifier Source: org_study_id

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