SHORT REPORTS |
Neuroscience and Psychiatry Unit, University of Manchester
Merseycare NHS Trust
The Spinney, Partnerships in Care, Atherton, Manchester
Bolton, Salford & Trafford Mental Health NHS Trust, UK
Correspondence: Correspondence: Dr Ian Anderson, Neuroscience and Psychiatry Unit, Room G907, Stopford Building, Oxford Road, Manchester M13 9PT, UK. Tel: +44 (0)161 275 7428; fax: +44 (0)161 275 7429; email: ian.anderson{at}manchester.ac.uk
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After determination of motor threshold, patients were randomised (sealed envelope) to active or sham treatment stratified by degree of treatment resistance (fewer than two v. two or more antidepressant trials equivalent to imipramine 150 mg). Treatment was thrice weekly for 4 weeks, extended for 2 more weeks in partial responders. Medication at entry continued unchanged through the trial. Assessments were made before and 2, 4, 6 and 12 weeks after the start of treatment with patients and assessors unaware of treatment allocation. Assessments were the MongomeryÅsberg Depression Rating Scale (MADRS; Montgomery & Åsberg, 1979), the Clinical Global Impression Severity and Improvement scales (CGIS, CGII; Guy, 1976), the Global Assessment of Functioning (GAF; American Psychiatric Association, 1994), and the self-rated Hospital Anxiety and Depression scale (HAD; Zigmond & Snaith, 1983). Adverse effects were determined by open questions and a checklist.
Treatment using a Magstim Super Rapid (Magstim, Whitland, UK) was given using a figure-of-eight and matching sham coil. After determination of the motor threshold (the minimum setting to stimulate the right first abductor pollicis brevis muscle), treatment sessions consisted of 1000 stimulations at 10 Hz in 20 trains each separated by 30 s at 110% of motor threshold over the left dorsolateral prefrontal cortex (5 cm anterior to the motor threshold point).
The primary outcome measures were MADRS score and HAD depression scores at treatment end-point given at least one post-baseline assessment (last observation carried forward; LOCF). Secondary outcome measures were other rating scale scores and responder status at treatment end-point (LOCF), scores at 12 weeks (LOCF and completers) and treatment withdrawal. Response was defined as a reduction of at least 50% in MADRS score plus a CGII rating of much or very much improved. Partial response at 4 weeks was defined as 2549% reduction in MADRS score from baseline. Statistical analysis using SPSS for Windows, release 11.5, was by univariate analysis of variance covaried for baseline values. Fishers exact test was used for categorical data and the exact proportion test for treatment allocation guesses.
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2 years) episode (active 46%; sham 38%). All but 3 patients were taking
antidepressants (active 92%; sham 88%); venlafaxine 34%; selective serotonin
reuptake inhibitors 24%; tricyclic antidepressants 14%; combinations were most
often with lithium (31%), an atypical antipsychotic (34%) or two
antidepressants (17%). More patients in the active group were receiving
venlafaxine (62 v. 13%; P<0.05), with a trend for the
opposite for selective serotonin reuptake inhibitors (8 v. 38%,
P<0.1). Three patients in the active group partially responded at 4 weeks and received a further 2 weeks treatment. Twenty-five cases were evaluable for efficacy; at treatment end-point the active group improved more than the sham group on primary outcomes (MADRS effect size 0.86, HAD depression effect size 0.92), GAF and in number of responders (Table 1). At 12 weeks significant benefit to the active treatment group on self-rated HAD depression remained.
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View this table: [in a new window] | Table 1 Effect of repetitive transcranial magnetic stimulation on efficacy outcome measures |
Two patients per group withdrew before completing 2 weeks of treatment (active: scalp pain, unrelated finger infection; sham: self-harm, treatment too stressful). Two patients in the active group received 100% (reduced from 110%) motor threshold stimulation owing to initial scalp discomfort, but overall the treatment was well tolerated. Three participants did not return for assessment at 12 weeks. One patient in the active group was mildly hypomanic at 4 weeks. Four days after his last treatment he had a series of epileptic seizures leading to hospitalisation, but a primary cause was not identified.
Of 25 participants, 19 (76%, P<0.05) guessed their correct treatment allocation; 3 gave a reason related to the treatment itself and 18 of 25 cited degree of improvement.
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Meta-analyses of the clinical efficacy of rTMS for depression have been conflicting (e.g Holtzheimer et al, 2001; Couturier, 2005). Variations in treatment methodology and patient factors make interpretation of the literature problematic (Loo & Mitchell, 2005). However, a number of recent studies of fast left frontal rTMS support the efficacy of higher dosages and a greater number of treatments (e.g. Fitzgerald et al, 2006).
Our study is limited by its small number of participants, relatively brief follow-up and uncontrolled concomitant medication. Nevertheless, taken together with other recent studies, our findings suggest that fast left frontal rTMS warrants further evaluation as a clinically available treatment. A clinically feasible protocol of three treatments per week appears effective, provided that sufficient stimulation strength and numbers of treatments are used.
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