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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: Completed NA study, sponsored by National Institute of Mental Health (NIMH).
NCT03289923 is a NA study that has completed, run by National Institute of Mental Health (NIMH). The registered enrollment target is 32 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
change in magnitude of BOLD signal with fMRI bold signal from DLPFC
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 |
What the finished NCT03289923 record still lists
NCT03289923 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which Sham TMS + Cognitive therapy is the first listed.
NCT03289923 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03289923's enrollment target sits among peer trials
32 1578th of 2000 higher than 409 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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