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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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References

1.Greden, JF, Riba, MB, McInnis, MG, eds. Treatment Resistant Depression: A Roadmap for Effective Care. Washington, DC: American Psychiatric Publishing, 2011.Google Scholar
2.Schäpfer, TE, Kayser, S. The role of nonpharmacological interventions in treatment-resistant depression. In: Kasper S, Montgomery S, eds. Treatment-Resistant Depression. Chichester: Wiley-Blackwell, 2013, p. 159182.Google Scholar
3.Bretlau, LG, Lunde, M, Lindberg, L, Unden, M, Dissing, S, Bech, P. Repetitive transcranial magnetic stimulation (rTMS) in combination with escitalopram in patients with treatment-resistant major depression: a double-blind, randomised, sham-controlled trial. Pharmacopsychiatry 2008;41:4147.Google Scholar
4.Martiny, K, Lunde, M, Bech, P. Transcranial low voltage pulsed electromagnetic fields in patients with treatment-resistant depression. Biol Psychiatry 2010;68:163169.Google Scholar
5.Heresco-Levy, U, Gelfin, G, Bloch, Bet al. A randomized add-on trial of high-dose D-cycloserine for treatment-resistant depression. Int J Neuropsychopharmacol 2013;16:501506.Google Scholar
6.Amsterdam, JD, Hornig, M, Nierenberg, AA, eds. Treatment-Resistant Mood Disorders. Cambridge: Cambridge University Press, 2001.Google Scholar
7.DUAG. Clomipramine dose-effect study in patients with depression: clinical end points and pharmacokinetics. Danish University Antidepressant Group (DUAG). Clin Pharmacol Ther 1999;66:152165.Google Scholar
8.European Agency for the Evaluation of Medicinal Products. Note for guidance on Good Clinical Practice. CPMP/ICH/135/95. London: European Agency for the Evaluation of Medicinal Products, 1997.Google Scholar
9.Sackeim, HA. The definition and meaning of treatment-resistant depression. J Clin Psychiatry 2001;62(Suppl. 16):1017.Google Scholar
10.Sheehan, DV, Lecrubier, Y, Sheehan, KHet al. The Mini-International Neuropsychiatric Interview (M.I.N.I.): the development and validation of a structured diagnostic psychiatric interview for DSM-IV and ICD-10. J Clin Psychiatry 1998;59(Suppl. 20):2233; ; quiz 34–57.Google Scholar
11.World Health Organization. International Statistical Classification of Diseases and Related Health Problems, 10th Revision (ICD-10). Diagnostic Criteria for Research. Geneva: World Health Organization, 1993.Google Scholar
12.Bech, P, Kastrup, M, Rafaelsen, OJ. Mini-compendium of rating scales for states of anxiety, depression, mania, and schizophrenia with corresponding DSM-III syndromes. Acta Psychiatr Scand Suppl 1986;326:137.Google ScholarPubMed
13.Bech, P, Gram, LF, Kragh-Sorensen, P, Reisby, N. DUAG: standardized assessment scales and effectiveness of antidepressants. Nord J Psychiatry 1988;42:511515.Google Scholar
14.Bech, P. Clinical Psychometrics. Oxford: Wiley Blackwell, 2012.Google Scholar
15.Bech, P, Lauritzen, L, Lunde, Met al. Psychometric analysis of the Melancholia Scale in trials with non-pharmacological augmentation of patients with therapy-resistant depression. Acta Neuropsychiatrica 2013:16.Google Scholar
16.Bech, P, Rasmussen, NA, Olsen, LR, Noerholm, V, Abildgaard, W. The sensitivity and specificity of the Major Depression Inventory, using the Present State Examination as the index of diagnostic validity. J Affect Disord Oct 2001;66:159164.Google Scholar
17.Lingjaerde, O, Ahlfors, UG, Bech, P, Dencker, SJ, Elgen, K. The UKU side effect rating scale. A new comprehensive rating scale for psychotropic drugs and a cross-sectional study of side effects in neuroleptic-treated patients. Acta Psychiatr Scand Suppl 1987;334:1100.Google Scholar
18.Siegel, S. Nonparametric Statistics for the Behavioural Sciences. New York: McGraw Hill, 1956.Google Scholar
19.Rush, AJ, Marangell, LB, Sackeim, HAet al. Vagus nerve stimulation for treatment-resistant depression: a randomized, controlled acute phase trial. Biol Psychiatry 2005;58:347354.Google Scholar
20.Quitkin, FM, Rabkin, JG, Ross, D, Stewart, JW. Identification of true drug response to antidepressants. Use of pattern analysis. Arch Gen Psychiatry 1984;41:782786.Google Scholar
21.Saarelainen, T, Hendolin, P, Lucas, Get al. Activation of the TrkB neurotrophin receptor is induced by antidepressant drugs and is required for antidepressant-induced behavioral effects. J Neurosci 2003;23:349357.Google Scholar
22.Nibuya, M, Morinobu, S, Duman, RS. Regulation of BDNF and trkB mRNA in rat brain by chronic electroconvulsive seizure and antidepressant drug treatments. J Neurosci 1995;15:75397547.Google Scholar
23.Rahbek, UL, Tritsaris, K, Dissing, S. Interactions of low frequency, pulsed electromagnetic fields with living tissue: biochemical responses and clinical results. Oral Biosci Med 2005;2:2940.Google Scholar
24.Dissing, S, Tritsaris, K, Hansen, AJ. Pulsed electrical fields cause activation of tyrosin kinase related cellular signalling in endothelial cells leading to transcription processes and angiogenesis. FASEB 2012;26:1129.29.Google Scholar