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NCT05172271 · ClinicalTrials.gov registry record · NA

Transcranial Electric Stimulation Therapy (TEST) for Treatment Resistant Depression (TRD)

A NA study of Major Depressive Disorder and Bipolar Disorder, sponsored by National Institute of Mental Health (NIMH).

Active
Registry status
NA
Development phase
8
Enrollment target
1
Study location

NCT05172271 is a NA study of Major Depressive Disorder and Bipolar Disorder that is active but no longer recruiting, run by National Institute of Mental Health (NIMH). The registered enrollment target is 8 participants, below the 377-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT05172271, a NA study of Major Depressive Disorder and Bipolar Disorder, is active but no longer recruiting, sponsored by National Institute of Mental Health (NIMH).

ACTIVE NOT RECRUITING
Registry status
NA
Development phase
8 participants
Enrollment target
1
Study location

Study Summary

Background: People with TRD are often helped by electroconvulsive therapy (ECT). But ECT can affect memory and thinking. Researchers want to study a treatment called TEST that uses less electricity. Objective: To study the safety and feasibility of TEST and assess its antidepressant effects. Eligibility: Adults aged 25-64 with major depression that has not been relieved by current treatments. Design: Participants will be admitted to the NIH Clinical Center for 5 18 weeks over 2 3 treatment phases. Their medications may be adjusted. Participants will be interviewed about their depression, side effects, and other treatments they are receiving. They will complete questionnaires. They will give blood and urine samples. Their brain waves and heart rhythm will be recorded. They will take tests of memory, attention, mental functioning, and thinking. Participants will have magnetic resonance imaging (MRI) scans of the head and brain. They will lie on a table that slides in and out of the scanner. Pictures of brain chemicals will also be taken. They may complete tasks during the MRI. Participants will receive TEST and/or sham treatments. They may receive optional ECT. An intravenous catheter will be placed in an arm vein to receive general anesthesia. Two electrodes will be placed on the front of their head. An electric current will be passed from the ECT machine through the electrodes. For sham treatments, they will not receive the electric current. Their breathing, heart rate, brain function, blood pressure, and body movements will be measured. Participants will have 7 follow-up visits over 6 months. Visits can be done via telehealth. Participation will last for up to 42 weeks.

Interventions

  • DEVICE MagPro TMS Stimulator and coil
  • DEVICE Thymatron(R) System IV
  • DEVICE Magnetic Resonance Imaging Scanner
  • OTHER ECT device without stimulation

Study Locations (1)

Maryland

  • National Institutes of Health Clinical Center - Bethesda

Trial Details

FieldValue
Enrollment Target 8 participants
Start Date 2022-11-08
Est. Completion 2027-10-31
Phase NA

What the Registry Record Tells You About NCT05172271

The ClinicalTrials.gov registry entry for NCT05172271 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 8 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 377-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (98% lower). The listed sponsor is National Institute of Mental Health (NIMH), which has 343 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Major Depressive Disorder appearing as the primary indexed condition, and to 4 interventions - of which MagPro TMS Stimulator and coil is the first listed.

NCT05172271 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.

Frequently Asked Questions

What is clinical trial NCT05172271 about?

NCT05172271 is a clinical study titled "Transcranial Electric Stimulation Therapy (TEST) for Treatment Resistant Depression (TRD)". Background: People with TRD are often helped by electroconvulsive therapy (ECT). But ECT can affect memory and thinking. Researchers want to study a treatment called TEST that uses less electricity. Objective: To study the safety and feasibility of TEST and assess its antidepressant effects. Eli...

What is the current status of trial NCT05172271?

This trial is currently active not recruiting. It is a NA study. The enrollment target is 8 participants. The study started on 2022-11-08. Estimated completion is 2027-10-31.

What conditions does trial NCT05172271 study?

This clinical trial studies the following conditions: Major Depressive Disorder, Bipolar Disorder, Unipolar Major Depression.

What interventions are being tested in trial NCT05172271?

The interventions under investigation include: MagPro TMS Stimulator and coil (DEVICE), Thymatron(R) System IV (DEVICE), Magnetic Resonance Imaging Scanner (DEVICE), ECT device without stimulation (OTHER).

Who is sponsoring clinical trial NCT05172271?

This trial is sponsored by National Institute of Mental Health (NIMH), which has 343 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05172271 being conducted?

This trial has 1 study location across Maryland. 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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