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

Published online by Cambridge University Press:  10 April 2014

Birgit Straasø
Affiliation:
Psychiatric Research Unit, Psychiatric Centre North Zealand, Copenhagen University Hospital, Hillerød, Denmark
Lise Lauritzen
Affiliation:
Psychiatric Research Unit, Psychiatric Centre North Zealand, Copenhagen University Hospital, Hillerød, Denmark
Marianne Lunde
Affiliation:
Psychiatric Research Unit, Psychiatric Centre North Zealand, Copenhagen University Hospital, Hillerød, Denmark
Maj Vinberg
Affiliation:
Department of Psychiatry, Psychiatric Centre Copenhagen, Copenhagen University Hospital, Denmark
Lone Lindberg
Affiliation:
Psychiatric Research Unit, Psychiatric Centre North Zealand, Copenhagen University Hospital, Hillerød, Denmark
Erik Roj Larsen
Affiliation:
Department of Affective Disorders, Mood Disorders Research Unit, Aarhus University Hospital, Denmark
Steen Dissing
Affiliation:
Department of Cellular and Molecular Medicine, Panum Institute, University of Copenhagen, Copenhagen, Denmark
Per Bech*
Affiliation:
Psychiatric Research Unit, Psychiatric Centre North Zealand, Copenhagen University Hospital, Hillerød, Denmark
*
Per Bech, Psychiatric Research Unit, Psychiatric Centre North Zealand, University of Copenhagen, Dyrehavevej 48, DK-3400 Hillerød, Denmark. Tel: +45 38 64 30 95; Fax: +45 48 26 38 77; E-mail: Per.bech@regionh.dk

Abstract

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.

Type
Original Articles
Copyright
Copyright © Scandinavian College of Neuropsychopharmacology 2014 

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