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Mechanism of Action of Electroconvulsive Therapy (MoA-ECT)

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ClinicalTrials.gov Identifier: NCT04059952
Recruitment Status : Recruiting
First Posted : August 16, 2019
Last Update Posted : August 16, 2019
Sponsor:
Information provided by (Responsible Party):
Joan A Camprodon, MD MPH PhD, Massachusetts General Hospital

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
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.

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Study Type : Observational
Estimated Enrollment : 136 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Mechanism of Action of Electroconvulsive Therapy
Actual Study Start Date : June 28, 2019
Estimated Primary Completion Date : June 1, 2021
Estimated Study Completion Date : June 1, 2021

Resource links provided by the National Library of Medicine


Group/Cohort 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.



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Changes in Functional Connectivity of Memory Circuits [ Time Frame: Through Treatment Completion, Average of 2 Months ]
    Measured by Magnetic Resonance Imaging, Memory Circuits Include Hippocampus and Dorsolateral Prefrontal Memory Hubs



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04059952


Contacts
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Contact: Christopher Funes, MS 6177248780 cjfunes@mgh.harvard.edu

Locations
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United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02129
Contact: Christopher Funes, MS    617-724-8780    cjfunes@mgh.harvard.edu   
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
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Principal Investigator: Joan Camprodon, MD MPH PHD Massachusetts General Hospital

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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     History of Changes
Other Study ID Numbers: 2012P001430
First Posted: August 16, 2019    Key Record Dates
Last Update Posted: August 16, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Joan A Camprodon, MD MPH PhD, Massachusetts General Hospital:
Electroconvulsive Therapy
Magnetic Resonance Imaging
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Bipolar Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Bipolar and Related Disorders