Trials / Completed

CompletedNCT05228457

Intensive TMS for Bipolar Depression

Intensive TMS for Rapid Relief of Bipolar Depression Symptoms

Status: Completed
Phase: N/A
Study type: Interventional
Enrollment: 34 (actual)

Sponsor: University of Pennsylvania · Academic / Other
Sex: All
Age: 18 Years – 70 Years
Healthy volunteers: Not accepted

Summary

Detailed description

The research study is being conducted to test whether using high dose spaced theta-burst rTMS (a form of transcranial magnetic stimulation) produces a significant reduction in depressive symptoms compared with sham. This project will recruit patients aged 18-70 with symptoms of bipolar depression who have failed (or not shown signs of improvement) after at least two prior treatments. The null hypothesis is that there will be no difference in reductions in depressive symptoms by the end of a five-day treatment period. The alternative hypothesis is that, compared with sham, active TMS will result in a greater reduction in depressive symptoms by the end of the treatment period. Participants will be randomly assigned to active or sham conditions: 50% to active and 50% to sham.

Conditions

Interventions

Type	Name	Description
DEVICE	Intensive intermittent theta-burst stimulation (iTBS)	Intensive iTBS is intermittent theta-burst stimulation (iTBS), a patterned form of repetitive transcranial magnetic stimulation (rTMS) over a specific brain region.

Timeline

Start date: 2022-03-01
Primary completion: 2024-02-19
Completion: 2024-02-19
First posted: 2022-02-08
Last updated: 2025-03-12
Results posted: 2025-03-12

Locations

1 site across 1 country: United States

Regulatory

FDA-regulated device study

Source: ClinicalTrials.gov record NCT05228457. Inclusion in this directory is not an endorsement.