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Concurrent fMRI-guided rTMS and Cognitive Therapy for the Treatment of Major Depressive Episodes

NCT03289923 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2026-02-11

No results posted yet for this study

Summary

Background:

Repetitive transcranial magnetic stimulation (rTMS) is a treatment for depression. It stimulates the brain. Researchers want to see if using magnetic resonance imaging (MRI) scans helps locate the best area for rTMS in each person. They also want to find other ways to make it more effective.

Objective:

To study the effects of combining MRI- guided transcranial magnetic stimulation (TMS) and talk therapy on the brain in people with depression.

Eligibility:

Adults ages 18-75 with a major depressive disorder and current depression. If taking an antidepressant, should have been doing so for at least 4 weeks.

Design:

Participants will be screened with medical and psychiatric history, psychiatric evaluation, physical exam, and blood and urine tests.

Phase 1 is 1-4 visits in 1 week. Participants will have:

* Brain MRI. Participants will lie on a table in a scanner.
* Questions about their medical history and psychology symptoms
* Tests of mood and thinking
* Tests of brain activity. Participants may do tasks during these tests:

* A cone with magnetic detectors is put on the head.
* A cap with electrodes is put on the scalp.
* TMS. A brief electrical current passes through a wire coil on the scalp.
* A metal disk will be placed on the arm. A nerve will be stimulated with a small electrical shock.

Phase 2 is about 6 to 7 weeks.

* There will be 30 daily sessions of combined therapy and repetitive TMS (rTMS) for 6 weeks.
* Participants will receive rTMS and another therapy by computer.
* For rTMS, repeated pulses will pass through the coil.
* This is followed by up to 3 additional visits, when:

* Participants will repeat Phase 1 tests
* Participants will rate their depression symptoms.

Phase 3 is 3 visits over 3 months. Participants will rate their depression symptoms and repeat some of the previous questionnaires and tests of mood and thinking.

Conditions

Interventions

DEVICE

Sham TMS + Cognitive therapy

Placebo Transcranial Magnetic Stimulation with cognitive therapy

DEVICE

Active TMS + Cognitive therapy

Active Transcranial Magnetic Stimulation with cognitive therapy.

Sponsors & Collaborators

  • National Institute of Mental Health (NIMH)

    lead NIH

Principal Investigators

  • Carlos A Zarate, M.D. · National Institute of Mental Health (NIMH)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-17
Primary Completion
2025-11-20
Completion
2025-11-20

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03289923 on ClinicalTrials.gov