TITLE
Efficacy of Intermittent Theta Burst Stimulation and 10-Hz High-Frequency Repetitive Transcranial Magnetic Stimulation in Treatment-Resistant Unipolar Depression
AUTHORS
Bulteau S; Sebille V; Fayet G; Thomas-Ollivier V; Deschamps T; Bonnin-Rivalland A; Laforgue E; Pichot A; Valriviere P; Auffray-Calvier E; Fortin J; Pereon Y; Vanelle JM; Sauvaget A. Institution Bulteau, Samuel. CHU de Nantes, Clinical Investigation Unit 18, Department of Addictology and Consultation-liaison Psychiatry, F-44000, Nantes, France, Samuel. University of Nantes, University of Tours, INSERM, SPHERE U1246, F-44000, Nantes, France. Fayet, Guillemette. CHU de Nantes, Department of Clinical Neurophysiology, F-44000, Nantes, France. Thomas-Ollivier, Veronique. University of Nantes, Laboratory ‘Movement, Interactions, Performance’ (E.A. 4334), F-44000, Nantes, France. Deschamps, Thibault. University of Nantes, Laboratory ‘Movement, Interactions, Performance’ (E.A. 4334), F-44000, Nantes, France. Bonnin-Rivalland, Annabelle. CHU de Nantes, Clinical Investigation Unit 18, Department of Addictology and Consultation-liaison Psychiatry, F-44000, Nantes, France. Laforgue, Edouard. CHU de Nantes, Clinical Investigation Unit 18, Department of Addictology and Consultation-liaison Psychiatry, F-44000, Nantes, France. Pichot, Anne. CHU de Nantes, Clinical Investigation Unit 18, Department of Addictology and Consultation-liaison Psychiatry, F-44000, Nantes, France. Valriviere, Pierre. CHU de Nantes, Clinical Investigation Unit 18, Department of Addictology and Consultation-liaison Psychiatry, F-44000, Nantes, France. Auffray-Calvier, Elisabeth. CHU de Nantes, Department of Neuroradiology, F-44000, Nantes, France. Fortin, June. CHU de Nantes, Delegation of Clinical Research and Innovation, F-44000, Nantes, France. Pereon, Yann. CHU de Nantes, Department of Clinical Neurophysiology, F-44000, Nantes, France. Vanelle, Jean-Marie. CHU de Nantes, Clinical Investigation Unit 18, Department of Addictology and Consultation-liaison Psychiatry, F-44000, Nantes, France. Sauvaget, Anne. CHU de Nantes, Clinical Investigation Unit 18, Department of Addictology and Consultation-liaison Psychiatry, F-44000, Nantes, France. Sauvaget, Anne. University of Nantes, University of Tours, INSERM, SPHERE U1246, F-44000, Nantes, France.
ELECTRONIC ADDRESS
samuel.bulteau@chu-nantes.fr.
SOURCE
Trials [Electronic Resource]. 18(1):17, 2017 Jan 13.
BACKGROUND
The treatment of depression remains a challenge since at least 40% of patients do not respond to initial antidepressant therapy and 20% present chronic symptoms (more than 2 years despite standard treatment administered correctly). Repetitive transcranial magnetic stimulation (rTMS) is an effective adjuvant therapy but still not ideal. Intermittent Theta Burst Stimulation (iTBS), which has only been used recently in clinical practice, could have a faster and more intense effect compared to conventional protocols, including 10-Hz high-frequency rTMS (HF-rTMS). However, no controlled study has so far highlighted the superiority of iTBS in resistant unipolar depression.
METHODS / DESIGN
This paper focuses on the design of a randomised, controlled, double-blind, single-centre study with two parallel arms, carried out in France, in an attempt to assess the efficacy of an iTBS protocol versus a standard HF- rTMS protocol. Sixty patients aged between 18 and 75 years of age will be enrolled. They must be diagnosed with major depressive disorder persisting despite treatment with two antidepressants at an effective dose over a period of 6 weeks during the current episode. The study will consist of two phases: a treatment phase comprising 20 sessions of rTMS to the left dorsolateral prefrontal cortex, localised via a neuronavigation system and a 6-month longitudinal follow-up. The primary endpoint will be the number of responders per group, defined by a decrease of at least 50% in the initial score on the Montgomery and Asberg Rating Scale (MADRS) at the end of rTMS sessions. The secondary endpoints will be: response rate 1 month after rTMS sessions; number of remissions defined by a MADRS score of <8 at the endpoint and 1 month after; the number of responses and remissions maintained over the next 6 months; quality of life; and the presence of predictive markers of the therapeutic response: clinical (dimensional scales), neuropsychological (evaluation of cognitive functions), motor (objective motor testing) and neurophysiological (cortical excitability measurements).
DISCUSSION
The purpose of our study is to check the assumption of iTBS superiority in the management of unipolar depression and we will discuss its effect over time. In case of a significant increase in the number of therapeutic responses with a prolonged effect, the iTBS protocol could be considered a first-line protocol in resistant unipolar depression.
