Journal of Affective Disorders 156 (2014) 219–223

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Preliminary communication

Treatment of major depression with bilateral theta burst stimulation: A randomized controlled pilot trial Christian Plewnia a,n, Patrizio Pasqualetti b, Stephan Große a, Sarah Schlipf a, Barbara Wasserka a, Bastian Zwissler a, Andreas Fallgatter a a Department of Psychiatry and Psychotherapy, Neurophysiology & Interventional Neuropsychiatry, University of Tübingen, Calwerstrasse 14, Tübingen D-72076, Germany b Medical Statistics & Information Technology, AFaR, Fatebenefratelli Hospital, Isola Tiberina, Rome

art ic l e i nf o

a b s t r a c t

Article history: Received 19 July 2013 Received in revised form 12 December 2013 Accepted 13 December 2013 Available online 28 December 2013

Background: Current efforts to improve clinical effectiveness and utility of repetitive transcranial magnetic stimulation (rTMS) in the treatment of major depression (MD) include theta burst stimulation (TBS), a patterned form of rTMS. Here, we investigated the efficacy of bilateral TBS to the dorsolateral prefrontal cortex (dlPFC) in patients with MD in additon to ongoing medication and psychotherapy. Methods: In this randomized-controlled trial, thirty-two patients with MD were treated for six weeks (thirty sessions) with either successively intermittent, activity enhancing TBS (iTBS) to the left and continuous, inhibiting TBS (cTBS) to the right dlPFC or with bilateral sham stimulation. Primary outcome measure was the proportion of treatment response defined as a Montgomery–Åsberg Depression Rating Scale (MADRS) r50% compared to baseline. Secondary outcomes comprised response and remission rates of the Hamilton Depression Rating Scale (HAMD) and the Beck Depression Inventory (BDI). Results: A larger number of responders were found in the cTBS (n ¼ 9) compared to the sham-stimulation (n ¼4) group (odds ratio: 3.86; Wald χ2 ¼ 3.9, p¼0.048). On secondary endpoint analysis, patientreported outcome as assessed by the BDI, pointed towards a higher rate of remitters in the cTBS (n ¼ 6) than in the sham (n ¼1) group (odds ratio: 9; Wald χ2 ¼ 3.5, p¼ 0.061). Limitations: With regard to the pilot character of the study and the small sample size, the results have to be considered as preliminary. Conclusions: These findings provide first evidence that six weeks treatment of MDD with iTBS to the left and cTBS to the right dlPFC for six weeks is safe, feasible and superior to sham stimulation applied addon to pharmacological and psychotherapeutic treatment. & 2013 Elsevier B.V. All rights reserved.

Keywords: Brain stimulation Therapy Major depression Clinical trial TMS Efficacy

1. Introduction High-frequency repetitive transcranial magnetic stimulation (rTMS) applied to the left dorsolateral prefrontal cortex (dlPFC) has been established as an effective treatment for major depressive disorder (Slotema et al., 2010; Fitzgerald and Daskalakis, 2012; Lee et al., 2012; George et al., 2013). It is currently recommended for moderately depressed patients when an initial treatment with antidepressant medication and psychotherapy failed (George and Post 2011). Nevertheless, considerable efforts are currently made to further enhance effectiveness and utility of rTMS as a treatment in major depression (Kammer and Spitzer, 2012). Up to now, effects in larger controlled studies were predominantly shown in subjects treated with rTMS as monotherapy (O0 Reardon et al., 2007; George et al., 2010; Herwig et al., 2007).

n

Corresponding author. Tel.: þ 49 7071 2986121; fax: þ 49 7071 295904. E-mail address: [email protected] (C. Plewnia).

0165-0327/$ - see front matter & 2013 Elsevier B.V. All rights reserved. http://dx.doi.org/10.1016/j.jad.2013.12.025

Therefore, it is conceivable that improvements of effectiveness by optimizing stimulation protocols would considerably increase the number of patients eligible for rTMS treatment. In addition, the mode of action different from pharmacological and psychotherapeutic approaches points towards additive or even synergistic effects that most likely have not yet reached their full potential. Recently, theta burst stimulation (TBS), a patterned form of rTMS with brief stimulation sessions has been put forward as a new option to induce a more effective modulation of cortical activity (Huang et al., 2005). The investigation of therapeutic effectiveness of this alternative stimulation paradigm for the treatment of various neuropsychiatric disorders has produced variable results (Eberle et al., 2010; Benninger et al., 2011; Plewnia et al., 2012). However, open studies have provided first preliminary evidence for an antidepressant effect of TBS (Chistyakov et al., 2010; Holzer and Padberg, 2010). As regards the efforts to improve effectiveness of rTMS treatment, sequential bilateral stimulation and extended number of pulses per session have been put forward as potential methods to

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optimize existing unilateral stimulation protocols (Fitzgerald et al. 2006; Berlim et al. 2012) although recent studies have not found superior efficacy (Fitzgerald et al. 2012). Nevertheless, available data suggest that rTMS treatment courses up to 6 weeks or more may be suitable to enhance the effectiveness of rTMS treatment of MD (O0 Reardon et al. 2007; George and Post, 2011). In order to proceed on the development of effective rTMS treatment protocols of depression, we conducted a randomized, sham-controlled trial applying 6 weeks of sequential facilitatory intermittent TBS (iTBS) to the left and inhibitory continuous TBS (cTBS) to the right dlPFC as an add-on treatment. We hypothesized that this innovative protocol would yield a greater therapeutic effect than sham stimulation in patients on regular treatment with antidepressants and psychotherapy.

2. Methods and materials 2.1. Subjects Patients were recruited from the in-patient units of the department of Psychiatry and Psychotherapy at the University Hospital of Tübingen. Inclusion criteria were right-handedness, age 18–75 years, with a DSM-IV diagnosis of MD, single episode or recurrent. Exclusion criteria for study participation included inability to give informed consent, seizures in medical history, neurological disorders, previous brain injuries, ferromagnetic implants in the brain, deep brain stimulation, cardiac pacemaker, psychotic symptoms, substance abuse, pregnancy, Benzodiazepines other than Lorazepam 4 1 mg/d. All patients of the study were on antidepressant medication at least for 2 weeks before randomization and remained so until the end of the trial. Antidepressant medications of the participating patients were: Mirtazapine (n ¼4, 7.5–45 mg/d), Venlafaxine (n ¼2, 75–150 mg), Amitriptyline (n ¼1, 50 mg), Paroxetine (n ¼2, 10–20 mg), Sertraline (n ¼1, 50 mg), Trimipramine (n ¼1, 50 mg), Citalopram (n ¼1, 40 mg), Escitalopram (n ¼1, 5 mg), Bupropion (n ¼1, 300 mg), Quetiapine (n ¼1, 250 mg), Lithium (n ¼1, 675 mg). In 10 patients (cTBS: n ¼6; Sham: n¼ 4) the antidepressant medication was changed during the course of TBS treatment. Treatment resistance was defined as no response to two different antidepressant medications and one combination of treatment with treatment periods of at least 4 weeks each in sufficient dosage for the current episode (Herwig et al. 2007). 2.2. Study overview In this randomized, sham-controlled trial, thirty-two patients were randomly assigned (16:16) to receive iTBS over the left dlPFC and cTBS over the right dlPFC or a sham stimulation over both hemispheres. Patients were randomized using a single computergenerated random number sequence. The patients and raters were blind to the treatment condition. Participants gave informed consent for a protocol following the Declaration of Helsinki, and the study was approved by the Institutional Review Board of the University of Tübingen Medical Faculty. The study was registered at ClinicalTrials.gov (Identifier: NCT01153139). 2.3. rTMS procedures TMS was applied using a Magstim Super Rapid (The Magstim Company Ltd, Whitland, UK) with a figure-eight coil (diameter of each winding: 70 mm, biphasic stimuli of 250 μs). The individual resting motor threshold (MT) was determined bilaterally at the beginning of the first treatment session and defined as the

minimal intensity needed to obtain a muscle twitch of the contralateral thumb in at least 5 of 10 stimuli. Stimulation (cTBS and iTBS) intensity was standardized at 80% of MT and applied successively to each hemisphere in alternating order. The dlPFC treatment sites were located by 10–20 EEG electrode placement system with F3 and F4 indicating the left and right stimulation areas (Herwig et al., 2003). Each stimulation session consisted of two trains of 600 stimuli applied in bursts of 3 pulses at 50 Hz given every 200 ms. Left-sided stimulation with iTBS was applied 20 times for 2 s every 10 s. Right-sided stimulation with cTBS was applied continuously for 40 s. Patients received rTMS treatment each working day for 6 weeks (30 sessions). The coil was handheld during stimulation trains to allow for optimal fixation. All patients were seated in a comfortable chair while they were receiving stimulation treatment. For adequate masking of the patients, sham stimulation was performed with the coil angled at 451 and 5 cm lateral to F3 and F4 above the temporal muscle (Herwig et al., 2007). Thus, sham stimulation is accompanied by similar auditory (clicking noise) and somatosensory (pricking, twitches of the temporal muscle) artifact. The patient and raters remained blind to the type of treatment until completion of the final data analysis. 2.4. Efficacy assessment The primary effective outcome measure was response to treatment defined as Montgomery–Åsberg Depression Rating Scale (MADRS) reduction of 50% or more compared to baseline at the end of the treatment. Secondary outcome measures comprised treatment response as assessed with the Hamilton Depression Rating Scale (HAMDr 50% baseline) and the Beck Depression Inventory (BDI r50% baseline as well as the equally dichotomous variable of depression remission defined as MADRS and HAMDr7 and BDI r8 (Frank et al., 1991). MADRS and BDI were obtained by the attending psychiatrist at baseline and after every week during the course of treatment. HAMD was measured before and after the end of treatment. Safety was monitored at every treatment visit by spontaneous adverse event reports. 2.5. Statistical analysis Statistical calculations were performed with SPSS 20.0 (SPSS Inc., www.spss.com). In order to assess whether bilateral TBS compared with sham stimulation increased treatment response (predefined primary outcome measure) and remission rate, a logistic regression model according to a previous major TMS treatment trial (George et al., 2010) was applied with the independent variables of treatment condition (TBS vs. sham), treatment resistance (yes vs. no), current depressive episode duration (months), and age (years). The current depressive episode duration was log transformed to reduce the variance and the detrimental effect of outliers. The sample size of 32 was chosen in order to have 80% probability to recognize a significant (at a two-tailed alpha level of 0.05) large increase of response rate, specifically from an expected 0.2 in the sham group (1 of 5 subjects) up to 0.67 in the TBS group (2 of 3 subjects). Unless stated otherwise, data were analyzed by intention to treat (ITT) defined as all randomized patients who received at least one treatment session. Missing values were imputed by carrying the last observation forward. The alpha level was set at 0.05 for all tests. 3. Results Baseline characteristics of the participants are summarized in Table 1. There were no significant differences between the groups.

C. Plewnia et al. / Journal of Affective Disorders 156 (2014) 219–223

Table 1 Demographic and clinical characteristics of the TBS and sham treatment groups (n¼ 32). TBS

Gender: male–female Age (SD) Duration of current episode: months (SD) Number of episodes Treatment resistent: number of patients Age at onset (SD) MADRS at baseline (SD) HAMD at baseline (SD) BDI at baseline (SD)

8–8 46.9 (13.2) 10.3 (7.5) 3.3 (2.1) 10 33.1 (11.5) 26.8 (7.1) 23.6 (5.3) 29.9 (9.3)

Sham

4–12 49.0 (13.6) 15.8 (18.9) 3.7 (5.8) 12 38.1 (15.7) 26.6 (7.1) 22.2 (5.9) 30.9 (6.7)

Difference (p)a 0.37 0.67 0.31 0.83 0.67 0.32 0.94 0.50 0.72

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Table 2 Number of patients achieving response and remission in the respective scores.

MADRS Responsea Remission HAMD Response Remission BDI Response Remission

TBS

Sham

Wald

Sig.

9 (6) 7 (2)

4 (4) 3 (3)

3904 3083

0.048 0.079

9 8

6 4

1605 2329

0.205 0.127

6 (6) 6 (5)

3 (2) 1 (1)

1351 3581

0.245 0.058

a Primary endpoint, in brackets: number of patients reaching criteria in the first 3 weeks.

MADRS: Montgomery–Åsberg Scale; HAMD: Hamilton Depression Scale; BDI: Beck Depression Inventory, SD: standard deviation. a

p-Values of t-tests and chi-squared tests as appropriate.

Twenty patients (sham: n ¼11; TBS: n¼ 9) completed the entire protocol of 6 weeks rTMS. In 10 participants treatment was discontinued because of patient decision (TBS: n ¼5, [4 responder], sham: n ¼5 [2 responder]). In detail, one subjects (TBS) terminated participation in the trial after 1 week of treatment in remission. Another patient (sham) decided to discontinue after 2 weeks due to worsening of the depression. Six patients (2 remitter [1 sham], 2 responder [1 sham], 2 without relevant symptom change [1 sham]) refused to continue treatment after 3 weeks. One patient (sham) discontinued after 4 weeks without improvement and one (TBS) after 5 weeks in remission. In two patients, receiving active TBS, treatment was discontinued for safety reasons. In one patient (responder), we were not able to completely rule out epileptogenic activity detected in a routine electroencephalogram recorded during the fifth week of treatment. Another patient (non-responder) presented with an exacerbation of restlessness and agitation without an improvement of depressive symptoms after 4 weeks of treatment. Patients reported the following transient side effects that did not result in termination of treatment: headache (TBS: 2, sham: 3), feeling of pressure in the head (TBS: 1), dizziness (TBS: 1), and tremor (TBS: 1). The primary analysis of response in the ITT sample (n ¼ 32) revealed a significant effect of treatment condition (Wald χ2 ¼3.9, p ¼0.047) with 9 responders (56%) in the TBS and 4 (25%) in the sham group. The odds ratio (OR) is 3.86 with a confidence interval (CI) of 0.86–17.32. There was a statistical trend indicating a better response in subjects with a shorter duration of the current episode (Wald χ2 ¼ 3.8, p ¼0.052). The other factors did not exert significant effects on the primary outcome measure. Of note, logistic regression applied on the MADRS response data alone results in a statistical trend towards a superiority of TBS (Wald χ2 ¼3.0, p ¼0.082). Remission or response was achieved after the 1st week in 2 patients (1 sham, 1 TBS), in the 2nd in 3 patients (2 sham, 1 TBS), in the 3rd in 2 (TBS), in the 4th in 2 patients (TBS), and in 4 patients (1 sham, 3 TBS) after the 5th week of treatment. Secondary analysis indicated a trendwise superiority of TBS treatment in respect to BDI remission (Wald χ2 ¼ 3.5, p¼ 0.061; OR¼ 9, 95% CI ¼0.936–86.53). Six patients treated with TBS (38%) and 1 patient (6%) receiving sham treatment reached remission criterion (BDI r8). Moreover, remission as measured with MADRS was achieved in 7 patients (44%) treated with TBS and 3 patients (19%) in the sham group (Wald χ2 ¼3.1, p ¼0.079; OR ¼3.37, 95% CI ¼0.68–16.65). The results of the other secondary measures point in the same direction but differences between sham stimulation and TBS treatment were not significant (Table 2). A descriptive analysis of the continuous data is given in Table 3. No difference was found between the mean reduction of BDI scores

Table 3 Continuous outcomes. TBS MARDS baseline Third week Sixth week HAMD baseline End of treatment BDI baseline Third week Sixth week

26.8 17.6 16.6 24.1 11.8 29.9 22.6 20.4

Sham (1.8) (2.4) (3.2) (1.3) (2.2) (2.9) (4.0) (4.0)

26.6 18.3 19.6 22.7 15.6 30.9 23.9 21.4

(1.8) (2.7) (3.0) (1.5) (2.4) (1.7) (2.6) (2.4)

MADRS: Montgomery–Åsberg Scale; HAMD: Hamilton Depression Scale; BDI: Beck Depression Inventory, SD: standard deviation.

after sham stimulation and after TBS. The mean difference between improvements after active and sham TBS treatment amounts to 3.2 points in the MADRS and 5.2 points in the HAMD.

4. Discussion This first randomized controlled pilot trial on the efficacy of TBS for the treatment of moderate to severe major depression found an augmentative therapeutic effect of sequential left excitatory and right inhibitory stimulation. A treatment response as quantified by a MADRS reduction of at least 50% (primary endpoint) was achieved in 56% and a remission (MADRS r7) in 44% of the patients in the active group. This effect was significantly higher in the patients treated with bilateral TBS than in those treated with sham stimulation. Remarkably, patient-reported depression severity measurements (BDI score) indicated a remission (BDI of 8 or less) in more than 31.2% (n ¼6) of the patients treated with bilateral TBS. Both weakness and strength of this study are the naturalistic clinical conditions. Participants received medication and psychotherapy according to the assessment of the attending physician blind for the stimulation condition. This demonstration of an effect under real-life everyday conditions is an important indicator for clinical-relevance of the effect. However, patients who did not respond to treatment, in this study predominantly in the sham group, may have received a more aggressive treatment potentially followed by a reduction of the actual difference between the effects of sham stimulation and TBS. Moreover, the concurrent treatment with antidepressants and their potential interaction with the TBS treatment most likely added statistical noise. Nevertheless, these data show that TBS specifically applied to both hemispheres can be an effective add-on treatment of major depression. In any case, these findings suggest and allow for a data-driven design of larger trials on the effects of TBS in the treatment of MD

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However, some specific aspects of the present study need to be considered: Bilateral long-term stimulation was used to optimize treatment efficacy (Berlim et al. 2012). Left excitatory enhancing and right activity reducing TBS has been applied on the basis of models that imply hypoactivity of the left and/or hyperactivity of the right dlPFC in correlation with depression (Schutter and van Honk 2005; Fitzgerald et al., 2008). However, since this study was designed to provide evidence for the efficacy of TBS, the findings do not allow for the conclusion that bilateral stimulation is superior to unilateral treatment. Moreover on the basis of previous data (O0 Reardon et al., 2007; George et al., 2010) a long-term treatment for 6 weeks was to ensure maximal efficacy. This approach proved being reasonable since 5 of the 7 remitters (MADRS r7) in the TBS group reached remission after 3 weeks of stimulation. However, this long-term treatment led to a higher number of premature discontinuations particularly after 3 weeks of treatment and remarkably often associated with response or remission. The optimal length of a TBS-treatment course needs to be determined in further studies. As control condition, we applied a well established shamstimulation by mimicking the auditory and somatosensory artifact. This might be less reliable than recent developments that apply a weak current during active and sham stimulation (George et al., 2010) that were not available for us. However, the results indicate that we induced a sham-stimulation effect of a size comparable to previous trials using this control condition add on to medication and without a significant difference between the conditions (Herwig et al., 2007). It is further noteworthy that the factors age, therapy resistance and duration of current episode included in the linear regression model did not exert significant effects on the primary endpoint. These factors were selected on the basis of data indicating that lower age, a shorter duration of the current episode and a lower degree of treatment resistance are predictors of response (Holtzheimer et al., 2004; Lee et al., 2012). This lack of effects is in line with a previous seminal study that used the same statistical approach (George et al., 2010). Analysis without the covariates confirms a trend towards a significant difference. However, to draw adequate conclusions from these results it is important to note that the small sample size obtained in a single clinical center limits its clinical implications and suggests larger multi-center trials before the clinical value of this treatment regimen can be adequately evaluated. The efficacy of TBS in the treatment of MD raises the question about the mechanism of action. The specific effects of inhibitory cTBS and excitatory iTBS have been demonstrated at the primary motor (Huang et al., 2005), sensory (Ragert et al., 2008), and visual (Franca et al., 2006) cortices. Furthermore, modulatory effects have been shown using different brain imaging techniques (CárdenasMorales et al., 2011; Orosz et al., 2012; Tupak et al., 2013). A reduction of inhibition was shown with iTBS also in the rat model (Benali et al., 2011). On the behavioral level, specific effects on executive functions were demonstrated after cTBS (Lee and D0 Esposito, 2012) and iTBS (Restle et al., 2012). Recently, it has been shown that an increase of left frontal activity ameliorates disturbed cognitive control in patients with MD (Wolkenstein, and Plewnia, 2013). This enhancement of activity in neural circuits subserving cognitive control has been put forward as a potential mode of antidepressant action in general and of non-invasive brain stimulation in particular (Roiser et al., 2012). On the basis of these data, an effectiveness of TBS in the treatment of MD is definitely plausible although the specific mechanisms of action have not yet been fully clarified. Besides the well documented effects on local cortical activity, modulations of broader functional network, (Hubl, et al., 2008), neurochemical effects (Stagg, et al., 2009), and oscillatory activity (Noh et al., 2012) are most likely

involved in the effects of TMS in general and TBS in particular. In any case, an optimization of the existing TMS-paradigms would be desirable and the quicker application of TBS compared to rTMS would be very useful (Fitzgerald and Daskalakis, 2012). In conclusion, TBS represents an effective and well-tolerated new option for the improvement of rTMS therapy of major depression that deserves further and more extensive clinical investigation. Not least, the use of TBS facilitates practicability because of the significantly shorter stimulation sessions and lower stimulation intensities. Role of funding source Dr. Plewnia is member of the Werner Reichardt Centre for Integrative Neuroscience, received research support and speakers honoraria by inomed Medizintechnik GmbH, Emmendingen, Germany and received funding not related to this research from the German Research Council (DFG; 525 PL1-1). Dr. Zwissler received a research grant from the Werner Reichardt Centre for Integrative Neuroscience (PP 2011-11) Dr. Fallgatter is member of the Werner Reichardt Centre for Integrative Neuroscience, received funding not related to this research from the German Research Council (DFG, SFB-TRR 58, KFO-125-1/2, GSC 1028), the Federal Ministery of Education and Research (BMBF, Panic Net Subproject C4) and sponsoring for an Investigator Initiated Trial by Astra Zeneca.

Conflict of interest The authors report no conflict of interest.

Acknowledgements None.

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Treatment of major depression with bilateral theta burst stimulation: a randomized controlled pilot trial.

Current efforts to improve clinical effectiveness and utility of repetitive transcranial magnetic stimulation (rTMS) in the treatment of major depress...
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