Efficacy of repetitive transcranial magnetic stimulation in the prevention of relapse of depression: study protocol for a randomized controlled trial

Huaning Wang, Yunyun Xue, Yunchun Chen, Ruiguo Zhang, Huaihai Wang, Yahong Zhang, Jingli Gan, Liyi Zhang, Qingrong Tan, Huaning Wang, Yunyun Xue, Yunchun Chen, Ruiguo Zhang, Huaihai Wang, Yahong Zhang, Jingli Gan, Liyi Zhang, Qingrong Tan

Abstract

Background: Depression is a chronic illness that generally requires lifelong therapy. Repetitive transcranial magnetic stimulation (rTMS) is a noninvasive technique with few side effects that has been reported to be useful in the treatment of depression. However, no studies to date have evaluated in a randomized controlled trial (RCT) the efficacy of rTMS for maintenance treatment of depression.

Methods/design: In this article, we report the design and protocol of a randomized, single-blind, placebo-controlled, parallel-group, multicenter study in China to evaluate the efficacy of rTMS in the prevention of relapse of depressive symptoms. In total, 540 patients, aged 18 to 60 years, diagnosed with depression and experiencing an acute exacerbation of depressive symptoms, will be enrolled. The study will consist of four phases: a screening/tolerability phase of up to 7 days; an open-label, flexible-dose lead-in phase of 8 weeks; an open-label, fixed-dose stabilization phase of 6 weeks; and a single-blind relapse prevention phase of 12 months. During the open-label phase, all patients will be treated with venlafaxine. Remitters with Hamilton Rating Scale for Depression (HAM-D₁₇) score ≤7 will be eligible to enter the single-blind phase and will be randomly assigned to one of three groups: group 1 on active rTMS and venlafaxine; group 2 on sham rTMS and venlafaxine; and group 3 on venlafaxine alone. Efficacy will be evaluated during the study using relapse assessment (time between subject randomization to treatment and the first occurrence of relapse). Secondary outcome measures will include: symptom changes, measured by the HAM-D₁₇; illness severity changes, measured by the Clinical Global Impression of Severity for Depression (CGI-S-DEP); and changes in subject functioning, assessed with the Personal and Social Performance (PSP)scale. Safety will be assessed throughout the study by monitoring of adverse events, clinical laboratory tests, electrocardiography (ECG), and measurements of vital signs (temperature, pulse, and blood pressure) and weight. Suicidality will be assessed by the Columbia Suicide Severity Rating Scale (C-SSRS).

Discussion: The result of this trial will assess the efficacy of rTMS in the prevention of relapse of symptoms of depression by determining whether rTMS in combination with an antidepressant is more efficacious than the antidepressant alone for maintenance of the clinical response.

Trial registration: ClinicalTrials.gov, NCT01516931.

Figures

Figure 1
Figure 1
Flow chart to illustrate the design of the trial. Enrolment and randomization of the participants, and the follow-up process are shown.

References

    1. Eccles M, Freemantle N, Mason J. North of England evidence-based guideline development project: summary version of guidelines for the choice of antidepressants for depression in primary care. North of England Anti-depressant Guideline Development Group. Fam Pract. 1999;14(2):103–111. doi: 10.1093/fampra/16.2.103.
    1. Sparing R, Mottaghy FM. Noninvasive brain stimulation with transcranial magnetic or direct currentstimulation (TMS/tDCS) – From insights into human memory to therapy of its dysfunction. Methods. 2008;14(4):329–337. doi: 10.1016/j.ymeth.2007.02.001.
    1. Dell’osso B, Camuri G, Castellano F, Vecchi V, Benedetti M, Bortolussi S, Altamura AC. Meta-review of metanalytic studies with repetitive transcranial magnetic stimulation (rTMS) for the treatment of major depression. Clin Pract Epidemiol Ment Health. 2011;14:167–177. doi: 10.2174/1745017901107010167.
    1. Charnsil C, Suttajit S, Boonyanaruthee V, Leelarphat S. An open-label study of adjunctive repetitive transcranial magnetic stimulation (rTMS) for partial remission in major depressive disorder. Int J Psychiatry Clin Pract. 2012;14(2):98–102. doi: 10.3109/13651501.2011.632681.
    1. Pridmore S, Bruno R, Turnier-Shea Y, Reid P, Rybak M. Comparison of unlimited numbers of rapid transcranial magnetic stimulation (rTMS) and ECT treatment sessions in major depressive episode. Int J Neuropsychopharmacol. 2000;14(2):129–134. doi: 10.1017/S1461145700001784.
    1. Grunhaus L, Schreiber S, Dolberg OT, Polak D, Dannon PN. A randomized controlled comparison of electroconvulsive therapy and repetitive transcranial magnetic stimulation in severe and resistant nonpsychotic major depression. Biol Psychiatry. 2003;14(4):324–331. doi: 10.1016/S0006-3223(02)01499-3.
    1. Dannon PN, Dolberg OT, Schreiber S, Grunhaus L. Three and six-month outcome following courses of either ECT or rTMS in apopulation of severely depressed individuals – preliminary report. Biol Psychiatry. 2002;14(8):687–690. doi: 10.1016/S0006-3223(01)01274-4.
    1. Li X, Nahas Z, Anderson B, Kozel FA, George MS. Can left prefrontal rTMS be used as a maintenance treatment for bipolar depression. Depress Anxiety. 2004;14(2):98–100. doi: 10.1002/da.20027.
    1. Abraham G, O’Brien S. Repetitive transcranial magnetic stimulation is useful for maintenance treatment. Can J Psychiatry. 2002;14(4):386.
    1. O’Reardon JP, Blumner KH, Peshek AD, Pradilla RR, Pimiento PC. Long-term maintenance therapy for major depressive disorder with rTMS. J Clin Psychiatry. 2005;14(12):1524–1528. doi: 10.4088/JCP.v66n1205.
    1. Danjou P, Hackett D. Safety and tolerance profile of venlafaxine. Int Clin Psychopharmacol. 1995;14(Suppl 2):15–20.
    1. Montgomery SA. Rapid onset of action of venlafaxine. Int Clin Psychopharmacol. 1995;14(Suppl 2):21–27.
    1. Ballenger JC. Clinical evaluation of venlafaxine. J Clin Psychopharmacol. 1996;14(3 Suppl 2):29S–35S. discussion 35S–36S.
    1. Mathers CD, Loncar D. Projections of global mortality and burden of disease from 2002 to 2030. PLoS Med. 2006;14(11):e442. doi: 10.1371/journal.pmed.0030442.
    1. Herwig U, Lampe Y, Juengling FD, Wunderlich A, Walter H, Spitzer M, Schönfeldt-Lecuona C. Add-on rTMS for treatment of depression: a pilot study using stereotaxic coil-navigation according to PET data. J Psychiatr Res. 2003;14(4):267–275. doi: 10.1016/S0022-3956(03)00042-6.
    1. Su TP, Huang CC, Wei IH. Add-on rTMS for medication-resistant depression: a randomized, double-blind, sham-controlled trial in Chinese patients. J Clin Psychiatry. 2005;14(7):930–937. doi: 10.4088/JCP.v66n0718.
    1. Janicak PG, Nahas Z, Lisanby SH, Solvason HB, Sampson SM, McDonald WM, Marangell LB, Rosenquist P, McCall WV, Kimball J, O’Reardon JP, Loo C, Husain MH, Krystal A, Gilmer W, Dowd SM, Demitrack MA, Schatzberg AF. Durability of clinical benefit with transcranial magnetic stimulation (TMS) in the treatment of pharmacoresistant major depression: assessment of relapse during a 6-month, multisite, open-label study. Brain Stimul. 2010;14(4):187–199. doi: 10.1016/j.brs.2010.07.003.

Source: PubMed

Patrocinadores y Colaboradores

Condiciones médicas

Intervenciones de drogas

3
Suscribir