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Maintenance Deep Transcranial Magnetic Stimulation Sessions Are Associated with Reduced Depressive Relapses in Patients with Unipolar Or Bipolar Depression

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Maintenance Deep Transcranial Magnetic Stimulation Sessions Are Associated with Reduced Depressive Relapses in Patients with Unipolar Or Bipolar Depression View metadata, citation and similar papers at core.ac.uk brought to you by CORE PERSPECTIVE ARTICLE published: 09provided February by 2015 Frontiers - Publisher Connector doi: 10.3389/fneur.2015.00016 Maintenance deep transcranial magnetic stimulation sessions are associated with reduced depressive relapses in patients with unipolar or bipolar depression Chiara Rapinesi 1,2, Francesco Saverio Bersani 3*, Georgios D. Kotzalidis 1, Claudio Imperatori 4, Antonio Del Casale 1,5, Simone Di Pietro1,Vittoria R. Ferri 1,2, Daniele Serata1, Ruggero N. Raccah6, Abraham Zangen7, Gloria Angeletti 1 and Paolo Girardi 1,2 1 Department of Neurosciences, Mental Health, and Sensory Organs NESMOS, School of Medicine and Psychology, Sant’Andrea Hospital, Sapienza University of Rome, Rome, Italy 2 Neuropsychiatric Unit, Villa Rosa, Suore Ospedaliere of the Sacred Heart of Jesus, Viterbo, Italy 3 Department of Neurology and Psychiatry, Policlinico Umberto I University Hospital, Sapienza University of Rome, Rome, Italy 4 Department of Human Sciences, European University of Rome, Rome, Italy 5 Department of Psychiatric Rehabilitation, P.Alberto Mileno Onlus Foundation, Vasto, Italy 6 ATID Ltd – Advanced Technology Innovation Distribution, Rome, Italy 7 Department of Life Sciences, Ben Gurion University of the Negev, Be’er Sheva, Israel Edited by: Introduction: Deep transcranial magnetic stimulation (dTMS) is a new form of TMS allow- Spyros N. Deftereos, ing safe stimulation of deep brain regions. The objective of this preliminary study was to Neurology-Neurophysiology Private Practice, Greece assess the role of dTMS maintenance sessions in protecting patients with bipolar disorder Reviewed by: (BD) or recurrent major depressive disorder (MDD) from developing depressive or manic Gopalkumar Rakesh, Duke University, relapses in a 12-month follow-up period. USA Dimitra Georgonikou, Psychiatry Methods: Twenty-four drug-resistant patients with a current depressive episode and a Private Practice, Greece diagnosis of MDD or BD have been enrolled in the study. All the participants underwent *Correspondence: daily dTMS sessions for 4 weeks. One group (maintenance – M group) received additional Francesco Saverio Bersani, maintenance dTMS sessions weekly or twice a week. Department of Neurology and Psychiatry, Policlinico Umberto I Results: After the first dTMS cycle, a significant reduction of Hamilton Depression Rat- University Hospital, Sapienza ing Scale (HDRS) scores was observed in all participants. Subsequently, the HDRS mean University of Rome, Viale dell’Università 30, Rome 00185, Italy scores did not significantly change over time in the M group, while it significantly increased e-mail: [email protected] in the non-M-group after 6 and 12 months. Discussion:This study confirms previous evidence of a positive therapeutic effect of dTMS on depressive symptoms and suggests that, after recovery from acute episodes, mainte- nance dTMS sessions may be helpful in maintaining euthymia in a 12-month follow-up period. Keywords: deep transcranial magnetic stimulation, bipolar disorder, neuropsychiatry, brain modulation, recurrent major depressive disorder INTRODUCTION left DLPFC and inhibitory low-frequency (<1 Hz) rTMS over the Repetitive transcranial magnetic stimulation (rTMS) is a non- right DLPFC (5). invasive technique used to treat drug-resistant depressive episodes There is evidence that clinical depression involves dysfunction in major depressive disorder (MDD) (1) and bipolar disorder in integrated neural pathways linking cortical, subcortical, and (BD) (2), as well as a range of other neurological and psychiatric limbic sites and related cellular and molecular mediators (6); it is conditions (3). rTMS therapy is administered through an electro- supported that effective stimulation of this pathway would ben- magnetic coil placed above patient’s scalp; the coil sends magnetic efit patients with depressive symptoms, but also that the regions pulses to the brain and induces a modulation of the electrical involved cannot be effectively stimulated utilizing standard rTMS activity in the underlying cortex (3). technology (7). For this reason, a new coil (H-coil) has been devel- Neuroimaging studies have led to the imbalance hypothesis of oped to allow safer stimulation of deeper brain regions [Deep depression, which postulates prefrontal asymmetry with relative Transcranial Magnetic Stimulation (dTMS)] (8). hypoactivity in the left dorsolateral prefrontal cortex (DLPFC), Several studies assessed the efficacy and safety of dTMS in MDD associated with a relative hyperactivity in the right DLPFC (4). [for review, see Ref. (9)], and one study assessed it in BD depres- Consistently, patients with depression have been found to benefit sion (10). Studies suggested a positive therapeutic effect of dTMS from excitatory high-frequency (more than 1 Hz) rTMS over the in patients with depression when used as add-on to medications; www.frontiersin.org February 2015 | Volume 6 | Article 16 | 1 Rapinesi et al. Maintenance dTMS in depression however, in spite of obtaining encouraging results, no studies so Patients had no other psychiatric comorbidity. Diagnoses were far investigated its long-term efficacy or the possible role of main- established through the Structured Clinical Interviews for DSM- tenance dTMS sessions in protecting patients from depressive or IV Axis I (SCID-I) and II (SCID-II); details are given in Table 1. manic relapses. We previously reported a 6-month improvement All patients gave written informed consent for participation in the of depression in a patient with rapid cycling BD and protection study and subsequent publication of results. The study received from mood episodes of any polarity (11). the approval of the local ethical boards (human experimentation Given the above considerations, in this preliminary study, we ethics committee of Sapienza University, Rome, Italy, and Villa aimed to further assess the efficacy of daily add-on dTMS in reliev- Rosa, Viterbo). ing drug-resistant bipolar and recurrent unipolar depression, and Inclusion criteria were a current depressive episode and a diag- also to evaluate the role of dTMS maintenance sessions in protect- nosis of BD or MDD; age 18–75 years; at least 5-year duration of ing patients from developing depressive or manic relapses during illness; failure to respond to at least three adequately dosed anti- a 12-month follow-up period. depressants from at least two distinct classes administered for at least 2 months each; availability of reliable informants; wish to MATERIALS AND METHODS participate in the study. Exclusion criteria were concomitant use PATIENTS of substances (with the exception of nicotine, occasional alcohol, The study was conducted at the Psychiatric Unit of the Sant’Andrea and three or less daily cups of coffee or tea); specific contraindica- University Hospital, Sapienza University, Rome, Italy, and at the tions to dTMS (history of seizures, pacemakers, or other electric Neuropsychiatric Unit, Villa Rosa Hospital, Viterbo. Recruitment devices); axis I diagnosis other than MDD and BD; having received was carried-out from October 2011 to April 2013; 24 consecutive dTMS in the past 12 months; left handedness. All patients were on drug-resistant, right-handed patients (13 male, 11 female) with a stable drug treatment from at least 1 month. Medication was left current DSM-IV-TR depressive episode were enrolled. All patients unchanged and its details are given in Table 1. were Caucasian. Eight had BD Type I (all from Rome), seven had A response of a depressive episode to treatment was defined as BD Type II (one from Viterbo, others from Rome), and nine had an at least 50% drop of Hamilton Depression Rating Scale (HDRS) MDD diagnosis (three patients from Viterbo, others from Rome). scores from baseline, a remission was a HDRS score of 7 or less, Table 1 | Participants’ clinical and sociodemographic characteristics. Patients with dTMS Patients without dTMS Mann–Whitney $2 P maintenance (N D 12), maintenance, N D 12, U-test mean ± SD mean ± SD Age 47.70 ± 8.90 48.50 ± 14.26 59.5 0.478 Men, N (%) 6 (50) 5 (41.7) 0.682a DSM-IV-TR diagnosis BD I, N (%) 4 (33.3) 4 (33.3) BD II, N (%) 4 (33.3) 3 (25) MDD, N (%) 4 (33.3) 5 (41.7) 0.254 0.881 Duration of disease (years) 15.00 ± 9.71 13.10 ± 9.62 60.0 0.514 Drug treatment Mood stabilizers, N (%) 9 (75) 7 (58.3) 0.386a Benzodiazepines, N (%) 1 (8.3) 5 (41.7) 0.059a Antidepressants, N (%) 5 (41.7) 7 (58.3) 0.414a Two or more psychotropic medications, N (%) 3 (25) 4 (33) 0.653a Clinical scales Baseline HDRS 23.83 ± 3.27 23.50 ± 3.28 66.5 0.755 Post-dTMS cycle HDRS 9.83 ± 1.27 9.92 ± 2.35 71.5 0.977 HDRS at 6-month follow-up 9.33 ± 2.23 13.75 ± 5.53 34.5 0.028 HDRS at 12-month follow-up 12.92 ± 5.78 16.17 ± 7.11 55.5 0.347 Baseline YMRS 2.42 ± 1.16 2.50 ± 0.67 60.0 0.514 Post-dTMS cycle YMRS 2.17 ± 0.58 2.75 ± 0.97 48.0 0.178 YMRS at 6-month follow-up 2.33 ± 0.89 2.83 ± 1.12 56.5 0.378 YMRS at 12-month follow-up 2.66 ± 1.16 3.08 ± 0.52 57.5 0.410 aOne-way Fisher exact tests. BD I, Bipolar Disorder Type I; BD II, Bipolar Disorder Type II; MDD, Major depressive disorder; HDRS, Hamilton Depression Rating Scale; YMRS, Young Mania Rating Scale. Significant results in bold characters. Frontiers in Neurology | Spinal Cord Medicine February 2015 | Volume 6 | Article 16| 2 Rapinesi et al. Maintenance dTMS in depression while a relapse and recurrence were considered the emergence frequency, number of pulses and trains, stimulus duration, and of a fully symptomatic depressive episode after full remission or inter-train intervals were as in the regular sessions. recovery, respectively (12, 13). STATISTICAL ANALYSIS CLINICAL MEASURES All analyses were performed with SPSS 19.0 statistical package Patients were assessed for mood disorder by trained clinicians for the social sciences (IBM, Armonk, NY, USA).
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