Hostname: page-component-78c5997874-lj6df Total loading time: 0 Render date: 2024-11-19T11:07:33.510Z Has data issue: false hasContentIssue false
  • English
  • Français

A randomized controlled trial with 4-month follow-up of adjunctive repetitive transcranial magnetic stimulation of the left prefrontal cortex for depression

Published online by Cambridge University Press:  15 October 2007

A. Mogg ,
G. Pluck ,
S. V. Eranti ,
S. Landau ,
R. Purvis ,
R. G. Brown ,
V. Curtis ,
R. Howard ,
M. Philpot  and
D. M. McLoughlin
A. Mogg
Affiliation:
Section of Old Age Psychiatry, Institute of Psychiatry, King's College London, London, UK
G. Pluck
Affiliation:
Section of Old Age Psychiatry, Institute of Psychiatry, King's College London, London, UK
S. V. Eranti
Affiliation:
Section of Old Age Psychiatry, Institute of Psychiatry, King's College London, London, UK
S. Landau
Affiliation:
Department of Biostatistics and Computing, Institute of Psychiatry, King's College London, London, UK
R. Purvis
Affiliation:
Section of Old Age Psychiatry, Institute of Psychiatry, King's College London, London, UK
R. G. Brown
Affiliation:
Department of Psychology, Institute of Psychiatry, King's College London, London, UK
V. Curtis
Affiliation:
Department of Psychiatry, Institute of Psychiatry, King's College London, London, UK
R. Howard
Affiliation:
Section of Old Age Psychiatry, Institute of Psychiatry, King's College London, London, UK
M. Philpot
Affiliation:
South London and Maudsley NHS Foundation Trust, London, UK
D. M. McLoughlin*
Affiliation:
Section of Old Age Psychiatry, Institute of Psychiatry, King's College London, London, UK
*
*Address for correspondence: Dr D. M. McLoughlin, Section of Old Age Psychiatry, Box PO70, Institute of Psychiatry, King's College London, De Crespigny Park, London SE5 8AF, UK. (Email: [email protected])
Get access Rights & Permissions [Opens in a new window]

Abstract

Background

Effectiveness of repetitive transcranial magnetic stimulation (rTMS) for major depression is unclear. The authors performed a randomized controlled trial comparing real and sham adjunctive rTMS with 4-month follow-up.

Method

Fifty-nine patients with major depression were randomly assigned to a 10-day course of either real (n=29) or sham (n=30) rTMS of the left dorsolateral prefrontal cortex (DLPFC). Primary outcome measures were the 17-item Hamilton Depression Rating Scale (HAMD) and proportions of patients meeting criteria for response (⩾50% reduction in HAMD) and remission (HAMD⩽8) after treatment. Secondary outcomes included mood self-ratings on Beck Depression Inventory-II and visual analogue mood scales, Brief Psychiatric Rating Scale (BPRS) score, and both self-reported and observer-rated cognitive changes. Patients had 6-week and 4-month follow-ups.

Results

Overall, Hamilton Depression Rating Scale (HAMD) scores were modestly reduced in both groups but with no significant group×time interaction (p=0.09) or group main effect (p=0.85); the mean difference in HAMD change scores was −0.3 (95% CI −3.4 to 2.8). At end-of-treatment time-point, 32% of the real group were responders compared with 10% of the sham group (p=0.06); 25% of the real group met the remission criterion compared with 10% of the sham group (p=0.2); the mean difference in HAMD change scores was 2.9 (95% CI −0.7 to 6.5). There were no significant differences between the two groups on any secondary outcome measures. Blinding was difficult to maintain for both patients and raters.

Conclusions

Adjunctive rTMS of the left DLPFC could not be shown to be more effective than sham rTMS for treating depression.

Keywords

Depressionrandomized controlled trialtranscranial magnetic stimulation
Type
Original Articles
Information
Psychological Medicine , Volume 38 , Issue 3 , March 2008 , pp. 323 - 333
Copyright
Copyright © Cambridge University Press 2007

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

Avery, DH, Holtzheimer, PE, Fawaz, W, Russo, J, Neumaier, J, Dunner, DL, Haynor, DR, Claypoole, KH, Wajdik, C, Roy-Byrne, P (2006). A controlled study of repetitive transcranial magnetic stimulation in medication-resistant major depression. Biological Psychiatry 59, 187–194.CrossRefGoogle ScholarPubMed
Barker, AT, Jalinous, R (1985). Non-invasive magnetic stimulation of human motor cortex. Lancet i (8437), 1106–1107.CrossRefGoogle ScholarPubMed
Beck, AT, Steer, RA, Brown, GK (1996). Beck Depression Inventory Manual, 2nd edn. The Psychological Corporation: San Antonio, TX.Google Scholar
Brown, RG, Scott, LC, Bench, CJ, Dolan, RJ (1994). Cognitive function in depression: its relationship to the presence and severity of intellectual decline. Psychological Medicine 24, 829–847.CrossRefGoogle Scholar
Burt, T, Lisanby, SH, Sackeim, HA (2002). Neuropsychiatric applications of transcranial magnetic stimulation: a meta analysis. International Journal of Neuropsychopharmacology 5, 73–103.CrossRefGoogle ScholarPubMed
Devanand, DP, Fitzsimons, L, Prudic, J, Sackeim, HA (1995). Subjective side effects during electroconvulsive therapy. Convulsive Therapy 11, 232–240.Google ScholarPubMed
Eranti, S, Mogg, A, Pluck, G, Landau, S, Purvis, R, Brown, RG, Howard, R, Knapp, M, Philpot, M, Rabe-Hesketh, S, Romeo, R, Rothwell, J, Edwards, D, McLoughlin, DM (2007). A randomized, controlled trial with 6-month follow-up of repetitive transcranial magnetic stimulation and electroconvulsive therapy for severe depression. American Journal of Psychiatry 164, 73–81.CrossRefGoogle ScholarPubMed
FDA Neurological Devices Panel. Executive Summary of premarket notification (510(k)) submission, K061053, submitted by Neuronetics, Inc., to request marketing clearance for the NeuroStar™ TMS System for the proposed indications for the treatment of Major Depresssive Disorder (http://www.fda.gov/ohrms/dockets/ac/07/briefing/2007-4273b1_01-FDAExecutiveSummary.pdf). Accessed 25 April 2007.Google Scholar
First, MB, Spitzer, RL, Gibbon, M, Williams, JBW (1996). Structured Clinical Interview for DSM-IV Axis I Disorders, Clinician Version (SCID-CV). American Psychiatric Press: Washington, DC.Google Scholar
Fitzgerald, PB, Benitez, J, de Castella, A, Daskalakis, ZJ, Brown, TL, Kulkarni, J (2006). A randomized, controlled trial of sequential bilateral repetitive transcranial magnetic stimulation for treatment-resistant depression. American Journal of Psychiatry 163, 88–94.CrossRefGoogle ScholarPubMed
Fitzgerald, PB, Brown, TL, Marston, NAU, Daskalakis, ZJ, de Castella, A, Kulkarni, J (2003). Transcranial magnetic stimulation in the treatment of depression: a double-blind, placebo-controlled trial. Archives of General Psychiatry 60, 1002–1008.CrossRefGoogle ScholarPubMed
Folstein, MF, Folstein, SE, McHugh, PR (1975). ‘Mini mental state’: a practical method for grading the cognitive state of patients for the clinician. Journal of Psychiatric Research 12, 189–198.CrossRefGoogle Scholar
Garcia-Toro, M, Mayol, A, Arnillas, H, Capllonch, I, Ibarra, O, Crespi, M, Mico, J, Lafau, O, Lafuente, L (2001). Modest adjunctive benefit with transcranial magnetic stimulation in medication-resistant depression. Journal of Affective Disorders 64, 271–275.CrossRefGoogle ScholarPubMed
George, MS, Lisanby, SH, Sackeim, HA (1999). Transcranial magnetic stimulation – applications in neuropsychiatry. Archives of General Psychiatry 56, 300–311.CrossRefGoogle ScholarPubMed
Gershon, AA, Dannon, PN, Grunhaus, L (2003). Transcranial magnetic stimulation in the treatment of depression. American Journal of Psychiatry 160, 835–845.CrossRefGoogle ScholarPubMed
Grunhaus, L, Dannon, PN, Schreiber, S, Dolberg, OH, Amiaz, R, Ziv, R, Lefkifter, E (2000). Repetitive transcranial magnetic stimulation is as effective as electroconvulsive therapy in the treatment of nondelusional major depressive disorder. Biological Psychiatry 47, 314–324.CrossRefGoogle ScholarPubMed
Hamilton, M (1960). A rating scale for depression. Journal of Neurology, Neurosurgery and Psychiatry 23, 56–62.CrossRefGoogle ScholarPubMed
Hausmann, A, Pascual-Leone, A, Kemmler, G, Rupp, CI, Lechner-Schoner, T, Kramer-Reinstadler, K, Walpoth, M, Mechtcheriakov, S, Conca, A, Weiss, EM (2004). No deterioration of cognitive performance in an aggressive unilateral and bilateral antidepressant rTMS add-on trial. Journal of Clinical Psychiatry 65, 772–782.CrossRefGoogle Scholar
Hermann, LL, Ebmeier, KP (2006). Factors modifying the efficacy of transcranial magnetic stimulation in the treatment of depression: a review. Journal of Clinical Psychiatry 67, 1870–1876.CrossRefGoogle Scholar
Koerselman, F, Laman, M, van Duijn, H, van Duijn, MAJ, Willems, MAM (2004). A 3-month, follow-up, randomized, placebo-controlled study of repetitive transcranial magnetic stimulation in depression. Journal of Clinical Psychiatry 65, 1323–1328.CrossRefGoogle ScholarPubMed
Kozel, FA, Nahas, Z, DeBrux, C, Molloy, M, Lorberbaum, JP, Bohning, D, Risch, SC, George, MS (2000). How coil-cortex distance relates to age, motor threshold, and antidepressant response to repetitive transcranial magnetic stimulation. Journal of Neuropsychiatry and Clinical Neurosciences 12, 376–384.CrossRefGoogle ScholarPubMed
Lisanby, SH, Gutman, D, Luber, B, Schroeder, C, Sackeim, HA (2001). Sham TMS: intracerebral measurement of the induced electrical field and the induction of motor-evoked potentials. Biological Psychiatry 49, 460–463.CrossRefGoogle ScholarPubMed
Loo, CK, Mitchell, PB (2005). A review of the efficacy of transcranial magnetic stimulation (TMS) treatment for depression, and current and future strategies to optimize efficacy. Journal of Affective Disorders 88, 255–257.CrossRefGoogle ScholarPubMed
Loo, CK, Mitchell, PB, McFarquhar, TF, Malhi, GS, Sachdev, PS (2007). A sham-controlled trial of the efficacy and safety of twice-daily rTMS in major depression. Psychological Medicine 37, 341–349.CrossRefGoogle ScholarPubMed
Loo, C, Sachdev, P, Esayed, H, McDarmont, B, Mitchell, P, Wilkinson, M, Parker, G, Gandevia, S (2001). Effects of a 2-to 4-week course of repetitive transcranial magnetic stimulation (rTMS) on neuropsychologic functioning, electroencephalogram, and auditory threshold in depressed patients. Biological Psychiatry 49, 615–623.CrossRefGoogle ScholarPubMed
Loo, CK, Taylor, JL, Gandevia, SC, McDarmont, BN, Mitchell, PB, Sachdev, PS (2000). Transcranial magnetic stimulation (TMS) in controlled treatment studies: Are some ‘sham’ forms active? Biological Psychiatry 47, 325–331.CrossRefGoogle ScholarPubMed
Nyenhuis, DL, Stern, RA, Yamamoto, C, Luchetta, T, Arruda, JE (1997). Standardization and validation of the Visual Analog Mood Scales. Clinical Neuropsychologist 11, 407–415.CrossRefGoogle Scholar
Overall, JE, Gorham, DR (1962). The brief psychiatric rating scale. Psychological Reports 10, 799–812.CrossRefGoogle Scholar
Palmieri, MG, Iani, C, Scalise, A, Desiato, MT, Loberti, M, Telera, S, Caramia, MD (1999). The effect of benzodiazepines and flumazenil on motor cortical excitability in the human brain. Brain Research 815, 192–199.CrossRefGoogle ScholarPubMed
Pridmore, S, Fernandes, JA, Nahas, Z, Liberatos, C, George, MS (1998). Motor threshold in transcranial magnetic stimulation: a comparison of a neurophysiological method and a visualization of movement method. Journal of ECT 14, 25–27.CrossRefGoogle Scholar
Rossi, S, Ferro, M, Cincotta, M, Ulivelli, M, Bartalini, S, Miniussi, C, Giovannelli, F, Passero, S (2007). A real electro-magnetic placebo (REMP) device for sham transcranial magnetic stimulation (TMS). Clinical Neurophysiology 78, 857–863.Google Scholar
Roth, M, Huppert, FA, Tym, E, Mountjoy, CQ (1988). CAMDEX: the Cambridge Examination for Mental Disorders of the Elderly. Cambridge University Press: Cambridge, UK.Google Scholar
Rumi, DO, Gattaz, WF, Rigonatti, SP, Rosa, MA, Fregni, F, Rosa, MO, Mansur, C, Myczkowski, ML, Moreno, RA, Marcolin, MA (2005). Transcranial magnetic stimulation accelerates the antidepressant effect of amitriptyline in severe depression: a double-blind placebo-controlled study. Biological Psychiatry 57, 162–166.CrossRefGoogle ScholarPubMed
Sackeim, HA, Ross, FR, Hopkins, N, Calev, L, Devanand, DP (1987). Subjective side effects acutely following ECT: associations with treatment modality and clinical response. Convulsive Therapy 3, 100–110.Google ScholarPubMed
Trivedi, MH, Rush, AJ, Wisniewski, SR, Nierenberg, AA, Warden, D, Ritz, L, Norquist, G, Howland, RH, Lebowitz, B, McGrath, PJ, Shores-Wilson, K, Biggs, MM, Balasubramani, GK, Fava, M (2006). Evaluation of outcomes with citalopram for depression using measurement-based care in STAR*D: implications for clinical practice. American Journal of Psychiatry 163, 28–40.CrossRefGoogle Scholar
Wechsler, D (1981). The Wechsler Adult Intelligence Test – Revised. The Psychological Corporation: New York, NY.Google Scholar