Unipolar DepressionMoA-ECTNCT04059952
Mechanism of Action of Electroconvulsive Therapy
An observational study of Unipolar Depression and Bipolar Depression, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
This is an observational neuroimaging study assessing the effects of ECT on the brains of patients with unipolar and bipolar depression. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Unipolar Depression, Bipolar Depression
- What is being tested?
- Electroconvulsive Therapy
- Type of treatment
- Medical device
- How many people
- 102 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jun 2019to 31 May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02129
About this study
This is an observational neuroimaging study assessing the effects of ECT on the brains of patients with unipolar and bipolar depression.
Read the 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.
- Conditions
- Unipolar Depression, Bipolar Depression
- Being tested
- Electroconvulsive Therapy
- Keywords
- Electroconvulsive Therapy, Magnetic Resonance Imaging
- Medical subject headings
- Depressive Disorder, Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electroconvulsive TherapyDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Unipolar Depression | Patients diagnosed with Major Depressive Disorder. Receives: Device: Electroconvulsive Therapy | |
| Bipolar Depression | Patients diagnosed with Bipolar I or II. Receives: Device: Electroconvulsive Therapy | |
| Healthy Control | Patients without psychiatric diagnoses. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Through Treatment Completion, Average of 2 Months
Secondary outcomes (1)
Changes in Functional Connectivity of Memory Circuits
Measured by Magnetic Resonance Imaging, Memory Circuits Include Hippocampus and Dorsolateral Prefrontal Memory Hubs
Measured: Through Treatment Completion, Average of 2 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2019
- Study start28 Jun 2019
- Primary completion31 May 2024
- Study completion31 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unipolar DepressionStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joan A Camprodon, MD MPH PhD, Massachusetts General Hospital
- Investigators
- Joan Camprodon, MD MPH PHD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04059952
- Sponsor's protocol ID
- 2012P001430
- Acronym
- MoA-ECT
- Status last verified
- Jun 2025
- First submitted
- 14 Aug 2019
- Last updated
- 12 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanism of Action of Electroconvulsive Therapy
- ClinicalTrials.gov ID
- NCT04059952
- Acronym / sponsor ID
- MoA-ECT / 2012P001430
- Conditions
- Unipolar Depression, Bipolar Depression
- Keywords
- Electroconvulsive Therapy, Magnetic Resonance Imaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 28 Jun 2019 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 16 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Unipolar Depression | – | Device: Electroconvulsive TherapyPatients diagnosed with Major Depressive Disorder. |
| Bipolar Depression | – | Device: Electroconvulsive TherapyPatients diagnosed with Bipolar I or II. |
| Healthy Control | – | –Patients without psychiatric diagnoses. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electroconvulsive TherapyElectrical currents are passed through the brain to intentionally trigger a controlled seizure in order to produce a therapeutic change in neuro-chemistry and circuitry. | Device | Bipolar Depression, Unipolar Depression |
Primary outcome
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
1 secondary outcome
Changes in Functional Connectivity of Memory Circuits
Time frame: Through Treatment Completion, Average of 2 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2025.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joan Camprodon, MD MPH PHD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Unipolar Depression and Bipolar Depression, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Functional Connectivity of Key Nodes (time frame: Through Treatment Completion, Average of 2 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2025.