Acta Neuropsychiatrica - Dose-remission of pulsating electromagnetic fields as augmentation in therapy-resistant depression: a randomized, double-blind controlled study

Objective To evaluate to what extent a twice daily dose of Transcranial Pulsating ElectroMagnetic Fields (T-PEMF) was superior to once daily in patients with treatment-resistant depression as to obtaining symptom remission after 8 weeks of augmentation therapy.
Methods A self-treatment set-up of the T-PEMF device was used allowing
self-administration by patients in own homes. All patients were treated
for 30 min per T-PEMF session. The antidepressant medication the
patients were receiving at baseline remained unchanged during the trial.
The patients were randomised to either one T-PEMF dose (active dose in
the morning and sham in the afternoon) or two T-PEMF doses (active dose
both morning and afternoon) in a double-blind procedure. A score of 7 or
less on the Hamilton Depression Scale (HAM-D₁₇) was the criterion of remission.
Results
In total 34 patients received active T-PEMF once a day and 31 patients
twice daily. After 5 weeks of therapy remission was obtained in 26.5%
and 32.3% on one dose and two doses of T-PEMF, respectively. After 8
weeks the rate of remission was 73.5% and 67.7%, respectively. The side
effects as measured by the Udvalget for Kliniske Undersøgelser scale
showed a better toleration of the antidepresssive medication in both
treatment groups, which was reflected by the WHO-5 well-being scale with
increased scores in both groups of patients.
Conclusion
The high remission rate obtained by the T-PEMF augmentation was not a
dose effect (one versus two daily T-PEMF sessions) but was explained by
the extension of the treatment period from 5 to 8 weeks.