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NCT03289923 · ClinicalTrials.gov registry record · NA
Concurrent fMRI-guided rTMS and Cognitive Therapy for the Treatment of Major Depressive Episodes
A NA study, sponsored by National Institute of Mental Health (NIMH).
- Completed
- Registry status
- NA
- Development phase
- 32
- Enrollment target
NCT03289923 is a NA study that has completed, run by National Institute of Mental Health (NIMH). The registered enrollment target is 32 participants.
The verdict
NCT03289923, a NA study, has completed, sponsored by National Institute of Mental Health (NIMH).
- COMPLETED
- Registry status
- NA
- Development phase
- 32 participants
- Enrollment target
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.
Interventions
- DEVICE Sham TMS + Cognitive therapy
- DEVICE Active TMS + Cognitive therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2018-05-17 |
| Est. Completion | 2025-11-20 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03289923
The ClinicalTrials.gov registry entry for NCT03289923 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 32 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Mental Health (NIMH), which has 343 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Sham TMS + Cognitive therapy is the first listed.
NCT03289923 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03289923 about?
NCT03289923 is a clinical study titled "Concurrent fMRI-guided rTMS and Cognitive Therapy for the Treatment of Major Depressive Episodes". 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 effec...
What is the current status of trial NCT03289923?
This trial is currently completed. It is a NA study. The enrollment target is 32 participants. The study started on 2018-05-17. Estimated completion is 2025-11-20.
What interventions are being tested in trial NCT03289923?
The interventions under investigation include: Sham TMS + Cognitive therapy (DEVICE), Active TMS + Cognitive therapy (DEVICE).
Who is sponsoring clinical trial NCT03289923?
This trial is sponsored by National Institute of Mental Health (NIMH), which has 343 total clinical trials registered on ClinicalTrials.gov.
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