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NIH-Funded Study: TMS Safe for Bipolar Depression with Mood Stabilizer Coverage

A 380-patient NIH-funded study found TMS can be safely used in bipolar depression when patients are stable on mood stabilizers, with mania-switch rates comparable to background population risk.

Clinical Trials October 22, 2025 · JAMA Psychiatry ↗

The largest controlled study of TMS in bipolar depression to date found that 6 weeks of left dorsolateral prefrontal stimulation was safe and effective in 380 patients with bipolar I or II depression, provided they were stable on a mood stabilizer at the time of treatment. Manic or hypomanic switch occurred in 4.7% of TMS-treated patients, statistically indistinguishable from the 4.2% rate in sham.

Response rates in the active arm were 47% versus 24% in sham. Effects were similar across bipolar I and II, and across patients whose most recent prior antidepressant trial had induced mood switching.

Bipolar depression has historically been excluded from major TMS trials because of theoretical concerns about precipitating mania. The NIH-funded study, which enrolled at 14 academic medical centers, is expected to substantially change clinical practice and inform updates to the American Psychiatric Association's bipolar disorder treatment guidelines, currently in revision.

Insurance coverage for TMS in bipolar depression has been spotty. Several payers indicated they would review the study and consider policy updates. Stable mood stabilizer coverage is likely to remain a coverage criterion.

Source

Reporting based on coverage from JAMA Psychiatry. This article is editorial summary intended for general information; it is not medical advice.

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