title: Dose-remission of pulsating electromagnetic fields as augmentation in therapy-resistant depression: a randomized, double-blind controlled study.
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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: 1Psychiatric Research Unit,Psychiatric Centre North Zealand,Copenhagen University Hospital,Hillerød,Denmark.
authors.forename: Birgit
authors.initials: B
authors.lastname: Straasø
authors.affiliation: 1Psychiatric Research Unit,Psychiatric Centre North Zealand,Copenhagen University Hospital,Hillerød,Denmark.
authors.forename: Lise
authors.initials: L
authors.lastname: Lauritzen
authors.affiliation: 1Psychiatric Research Unit,Psychiatric Centre North Zealand,Copenhagen University Hospital,Hillerød,Denmark.
authors.forename: Marianne
authors.initials: M
authors.lastname: Lunde
authors.affiliation: 2Department of Psychiatry,Psychiatric Centre Copenhagen,Copenhagen University Hospital,Denmark.
authors.forename: Maj
authors.initials: M
authors.lastname: Vinberg
authors.affiliation: 1Psychiatric Research Unit,Psychiatric Centre North Zealand,Copenhagen University Hospital,Hillerød,Denmark.
authors.forename: Lone
authors.initials: L
authors.lastname: Lindberg
authors.affiliation: 3Department of Affective Disorders,Mood Disorders Research Unit,Aarhus University Hospital,Denmark.
authors.forename: Erik Roj
authors.initials: ER
authors.lastname: Larsen
authors.affiliation: 4Department of Cellular and Molecular Medicine,Panum Institute,University of Copenhagen,Copenhagen,Denmark.
authors.forename: Steen
authors.initials: S
authors.lastname: Dissing
authors.affiliation: 1Psychiatric Research Unit,Psychiatric Centre North Zealand,Copenhagen University Hospital,Hillerød,Denmark.
authors.forename: Per
authors.initials: P
authors.lastname: Bech
mesh_terms: D000328:Adult; D000928:Antidepressive Agents / Q000627:therapeutic use; D003131:Combined Modality Therapy; D061218:Depressive Disorder, Treatment-Resistant / Q000188:drug therapy / Q000628:therapy*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D012646:Self Administration; D050781:Transcranial Magnetic Stimulation; D016896:Treatment Outcome
chemical_list: D000928:Antidepressive Agents