- Design
- Triple-blind, sham-controlled randomised trial
- Population
- 108 adults aged 60 and over with moderate to severe depression, not taking antidepressants
- Primary outcome
- Change in Hamilton Depression Rating Scale score at week 6
- Effect
- Week 6 difference −1.65 (95% CI −3.38 to 0.08); week 12 −1.89 (−3.75 to −0.03); response 52% vs 33%
In a triple-blind, sham-controlled trial, 108 adults aged 60 and over with moderate to severe major depression, none taking antidepressants, received bilateral theta-burst stimulation to the dorsolateral prefrontal cortex: 20 daily sessions over four weeks, then boosters at weeks 6, 8 and 12. The trial was published in March 2026.
At week 6, the primary time point, the drop in Hamilton depression score was not significantly greater than sham. By week 12, active stimulation was ahead by about two points, with response in 52% against 33%.
Older adults often tolerate antidepressants poorly, so a non-drug option with a short daily session is attractive. But the primary endpoint was missed, the week-12 difference is modest and only just significant, and the trial was small.
Theta-burst stimulation is a reasonable option to discuss for older adults who cannot take or have not responded to antidepressants, where it is available, with the expectation that benefit may take up to three months. It is not yet a reason to choose stimulation over medication or psychotherapy first.
- Consider theta-burst stimulation for older adults who cannot tolerate antidepressants, where it is offered.
- Set expectations: benefit in this trial appeared by 12 weeks, not 6.
- Plan booster sessions after the daily course, as the trial did.
- Screen for contraindications such as seizure history and metal implants before referral.
- Keep medication and psychotherapy as first-line options; this trial does not displace them.
Why it matters
It offers older adults who struggle with antidepressants a possible alternative, provided they are told the benefit is slow.
Don't overread it
The primary week-6 endpoint was missed; the week-12 benefit is a secondary finding in a small trial.
The statistics, in plain English
At week 6 the confidence interval (−3.38 to 0.08) crossed zero, so no difference was shown on the primary endpoint. At week 12 the interval (−3.75 to −0.03) only just excluded zero, so the benefit is real but could be very small. Because week 12 was not the primary time point, it is weaker evidence than the headline suggests.
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