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NCT03276793 · ClinicalTrials.gov registry record · NA

Brain Connectivity in Depression

A NA study of Depression, sponsored by Brigham and Women's Hospital.

Recruiting
Registry status
NA
Development phase
260
Enrollment target
4
Study locations

NCT03276793 is a NA study of Depression that is actively recruiting participants, run by Brigham and Women's Hospital. The registered enrollment target is 260 participants, below the 786-participant average among 679 other Depression trials with a reported enrollment target (67% lower). The trial reports 4 study locations across 2 states.

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The verdict

NCT03276793, a NA study of Depression, is actively recruiting participants, sponsored by Brigham and Women's Hospital.

RECRUITING
Registry status
NA
Development phase
260 participants
Enrollment target
4
Study locations

Study Summary

This study originally included 140 subjects with medication-refractory depression undergoing 10 Hz transcranial magnetic stimulation (10Hz-TMS) to the left dorsal lateral prefrontal cortex (DLPFC), with the goal of having 60 completers with good quality data. Subjects were recruited from the TMS clinics at Beth Israel Deaconess Medical Center, Brigham \& Women's Hospital, and Butler Hospital. Subjects underwent an hour-long MRI scanning session, an optional DNA-sample collection, up to three 20 minute neuronavigation sessions for marking the site of TMS stimulation, questionnaires, and a behavioral testing battery before and after their TMS treatment course. The task battery included the Emotion Conflict Resolution (ECR) task, Multi-Source Interference Task (MSIT), War Game (Gambling) task, and Associative Learning with Reversal task. Subjects' scores on the Quick Inventory of Depressive Symptomatology (QIDS) and Beck Depression Inventory (BDI) were assessed before and after the TMS course. MRI data was utilized to identify brain regions whose connectivity to the stimulation site co-varies with the aforementioned measures of symptom improvement. This was the only study group until August 30, 2022, and the primary outcome was analyzed for the 10Hz-TMS group. Due to changes in clinical standard of care from 10Hz-TMS to a newer version of TMS termed intermittent theta burst (iTBS), in September 2022 a second group was added to include patients receiving this new form of TMS. This second group included another 100 patients with medication-refractory depression undergoing iTBS to the left dorsal lateral prefrontal cortex (DLPFC), with the intent to have 80 completers. Massachusetts General Hospital was added as a data collection site in lieu of Butler Hospital. Subjects will undergo an hour-long MRI scanning session, up to three 20 minute neuronavigation sessions for marking the site of TMS stimulation, questionnaires, and a behavioral testing battery before and after t

Conditions Studied

Interventions

  • OTHER MRI scan
  • BEHAVIORAL Behavioral testing

Study Locations (4)

Massachusetts

  • Brigham and Women's Hospital - Boston
  • Massachusetts General Hospital - Boston
  • Beth Israel Deaconess Medical Center - Boston

Rhode Island

  • Butler Hospital - Providence

Trial Details

FieldValue
Enrollment Target 260 participants
Start Date 2018-04-03
Est. Completion 2027-10-31
Phase NA

Sponsor

Brigham and Women's Hospital

937 total trials

What the Registry Record Tells You About NCT03276793

The ClinicalTrials.gov registry entry for NCT03276793 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 260 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 786-participant average among 679 other Depression trials with a reported enrollment target (67% lower). The listed sponsor is Brigham and Women's Hospital, which has 937 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Depression appearing as the primary indexed condition, and to 2 interventions - of which MRI scan is the first listed.

NCT03276793 reports 4 study locations spanning 2 distinct geographic areas - top geographies include Massachusetts, Rhode Island.

Frequently Asked Questions

What is clinical trial NCT03276793 about?

NCT03276793 is a clinical study titled "Brain Connectivity in Depression". This study originally included 140 subjects with medication-refractory depression undergoing 10 Hz transcranial magnetic stimulation (10Hz-TMS) to the left dorsal lateral prefrontal cortex (DLPFC), with the goal of having 60 completers with good quality data. Subjects were recruited from the TMS cli...

What is the current status of trial NCT03276793?

This trial is currently recruiting. It is a NA study. The enrollment target is 260 participants. The study started on 2018-04-03. Estimated completion is 2027-10-31.

What conditions does trial NCT03276793 study?

This clinical trial studies the following conditions: Depression.

What interventions are being tested in trial NCT03276793?

The interventions under investigation include: MRI scan (OTHER), Behavioral testing (BEHAVIORAL).

Who is sponsoring clinical trial NCT03276793?

This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03276793 being conducted?

This trial has 4 study locations across Massachusetts, Rhode Island. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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