NCT04278521

Brief Summary

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

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable major-depressive-disorder

Timeline
1mo left

Started Nov 2011

Longer than P75 for not_applicable major-depressive-disorder

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
8.3 years until next milestone

First Submitted

Initial submission to the registry

February 18, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 20, 2020

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Last Updated

December 12, 2025

Status Verified

December 1, 2025

Enrollment Period

14.6 years

First QC Date

February 18, 2020

Last Update Submit

December 5, 2025

Conditions

Keywords

Transcranial Magnetic Stimulation

Outcome Measures

Primary Outcomes (1)

  • Changes in Functional Connectivity of Key Nodes in Depression

    Measured by Magnetic Resonance Imaging

    Through Treatment Completion, Average of 6 Weeks

Study Arms (1)

Unipolar Depression

OTHER

Patients diagnosed with unipolar depression.

Device: Transcranial Magnetic Stimulation

Interventions

Transcranial magnetic stimulation uses a rapidly changing magnetic field to induce current in brain tissue non-invasively. It is common procedure in both clinical and research settings, and it has well established guidelines for safe an ethical use which maximize safety for all subjects.

Also known as: TMS
Unipolar Depression

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males and females between the ages of 18-80
  • DSM-IV diagnosis of Depressive Episode
  • Patients requiring TMS treatment as part of their psychiatric care

You may not qualify if:

  • Comorbid DSM-IV primary diagnoses of schizoaffective disorder, schizophrenia or dementia.
  • Substance use disorder (abuse or dependence) with active use within the last 3 months
  • Severe or unstable medical illness.
  • MRI contraindications as determined by MGH department of radiology.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02129, United States

Location

MeSH Terms

Conditions

Depressive Disorder, MajorDepression

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental DisordersBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Study Officials

  • Joan Camprodon, MD, PhD, MPH

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of Division of Neuropsychiatry, Director of TMS Clinic, Director of Lab for Neuropsychiatry and Neuromodulation

Study Record Dates

First Submitted

February 18, 2020

First Posted

February 20, 2020

Study Start

November 1, 2011

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

December 12, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations