Ultra-brief pulse ECT in bipolar and unipolar depressive disorder: differences in speed of response

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1 Disorders 29: 11: ª 29 The Authors Journal compilation ª 29 Blackwell Munksgaard BIPOLAR DISORDERS Brief Report Ultra-brief pulse ECT in bipolar and unipolar depressive disorder: differences in speed of response Sienaert P, Vansteelandt K, Demyttenaere K, Peuskens J Ultra-brief pulse ECT in bipolar and unipolar depressive disorder: differences in speed of response Disord 29: 11: ª 29 The Authors Journal compilation ª 29 Blackwell Munksgaard Objectives: There is little evidence for differences in response and speed of response to electroconvulsive therapy (ECT) between patients with bipolar and patients with unipolar depressive disorder In the only prospective study to date, Daly et al ( Disord 21; 3: 95 14) found patients with bipolar depression to show more rapid clinical improvement and require fewer treatments than unipolar patients In this study, response and speed of response of patients with unipolar and bipolar depression treated with ultra-brief pulse ECT were compared Methods: All patients (n = 64) participated in a randomized trial comparing ultra-brief pulse bifrontal ECT at 15 times seizure threshold and unilateral ECT at 6 times seizure threshold Thirteen patients (23%) had DSM-IV-defined bipolar depression The Hamilton Rating Scale for Depression and Clinical Global Impression scale were administered at baseline and repeated weekly during and after the course of treatment by a blinded rater At the same time point, the Beck Depression Inventory and the Patient Global Impression scale were administered Speed of response was analyzed using survival analyses Results: Patients with bipolar and unipolar depression did not differ in rates of response or remission following the ECT course, nor in response to unilateral or bifrontal ECT Patients with bipolar depression, however, showed a more rapid response than patients with unipolar depression Conclusions: Patients with bipolar depression tend to show more rapid clinical improvement with ECT than patients with unipolar depression Pascal Sienaert a,b, Kristof Vansteelandt b, Koen Demyttenaere c and Joseph Peuskens b a ECT Department and Department of Mood Disorders, b University Psychiatric Center, Catholic University of Leuven, Campus Kortenberg, Kortenberg, c University Psychiatric Center, Catholic University of Leuven, Campus Leuven, Leuven, Belgium Key words: bipolar disorder depressive disorder electroconvulsive therapy pulse width speed of response Received 19 August 2, revised and accepted for publication 17 November 2 Corresponding author: Pascal Sienaert, MD University Psychiatric Center Catholic University of Leuven Campus Kortenberg Leuvensesteenweg Kortenberg, Belgium Fax: pascalsienaert@uc-kortenbergbe Trial Registration number: ISRCTN Electroconvulsive therapy (ECT) is a powerful, acute treatment for severe and resistant mood disorders, with efficacy in both unipolar (UP) (1) and bipolar (BP) disorder In patients with BP disorder, ECT has been shown to be effective in The authors of this paper do not have any commercial associations that might pose a conflict of interest in connection with this manuscript 41 depressive (2), manic (3), and mixed states (4, 5), and in both the acute and maintenance phases (6) The predictive value of the polarity of the mood disorder remains unclear, although according to the few available data, there does not seem to be a significant difference in response to ECT in patients with BP and UP depressive disorder (2, 7 9) In one retrospective study, however, patients with UP depression were more likely to show marked improvement than patients with BP

2 ECT in bipolar disorder depression (1) There is little evidence for differences in speed of response to ECT between patients with BP or UP depressive disorder In an old retrospective study, Perris and dõelia (11) reported a faster response in patients with BP depressive disorders These results were more recently corroborated in a prospective study Daly et al (12) found patients from three treatment protocols with BP depression (n = 66) to show more rapid clinical improvement and require fewer treatments than UP patients (n = 162), regardless of ECT technique In this study, response and speed of response of patients with UP and BP depression treated with ultra-brief pulse ECT were compared Methods Study population Patients were participants in a randomized trial comparing ultra-brief pulse bifrontal (BF) ECT at 15 times seizure threshold (ST) and unilateral (UL) ECT at 6 times ST (13) Patients with DSM- IV-defined major depressive disorder, either BP or UP, with or without psychotic symptoms, with an age of 1 years or older, who were referred for ECT and who had a minimum baseline score of 1 on the 17-item Hamilton Rating Scale for Depression (HRSD) (14) were eligible for study inclusion Exclusion criteria included schizophrenia, neurological illness, cognitive disorder, substance abuse or dependence within the previous year, or ECT within the past six months Severity of medication resistance was not formally assessed, but all patients were resistant to at least two medication trials Patients provided written informed consent, and the study was approved by the Ethical Committee of the Catholic University of Leuven, Leuven, Belgium Treatment Patients were withdrawn from antidepressants at least three days before starting ECT Lorazepam up to 4 mg day or clothiapine up to 4 mg day was allowed if needed for agitation or anxiety The patients received BF or UL ECT by random assignment Anesthetic medications consisted of glycopyrrolate (2 mg), methohexital (1 mg kg) or etomidate (2 mg kg), and succinylcholine (1 mg kg), all given intravenously Treatment was given two times a week with a square-wave, brief-pulse, constant-current device (MECTA SR1 5Q; Lake Oswego, OR, USA) At the first treatment, the subjectõs ST was established by empirical titration Subsequent treatments were given at 15 times the ST for BF placements, and 6 times the ST for UL placements Stimulus train duration was the longest, stimulus frequency the lowest allowed for the dose selected Motor seizure duration was monitored with the cuff technique, and two channels of electroencephalography (frontal-mastoid) were recorded Evaluation of outcome HRSD scores and Clinical Global Impression (CGI) (15) scores were obtained at baseline, once every week until response remission, and at one and six weeks after finishing the course by a clinical rater blind to diagnostic subtype and to the ECT technique used Self-rated questionnaires were Beck Depression Inventory (BDI) (16) and Patient Global Impression (PGI) (15) No minimum or maximum number of treatments was imposed on patients who showed substantial clinical improvement ECT was continued until patients achieved remission or had a plateau in improvement over at least two consecutive evaluations Remission was defined according to both moderate and strict criteria The moderate criteria (remitter 1), required an HRSD score of 1 The strict criteria (remitter 7) required an HRSD score of 7, which corresponds to full remission (17) Response was defined as a decrease in HRSD score of 5% As part of a larger cognitive test battery, Mini Mental State scores (MMSE) (1) were obtained at baseline and at one and six weeks after finishing the course Statistical analysis Baseline comparisons between patients with UP and BP depression were analyzed with standard descriptive tests: chi-square tests (or exact tests) for categorical variables and t-tests (or Wilcoxon twosample tests) for continuous variables To examine the difference between patients with UP and BP depression in outcome (response, remission 1 and 7), chi-square (or exact) tests were used In addition, to control for the effect of electrode position, logistic regression analyses were also performed, with outcome being predicted on the basis of both diagnosis and electrode position Further, the mean and median numbers of sessions needed to meet response and remission criteria were compared between patients with UP and BP depression by t-tests The latter analysis, however, is necessarily restricted to the group of patients who met these criteria Therefore, discrete time hazard models were also estimated, since these are 419

3 Sienaert et al more powerful to detect differences between groups (19) Likelihood ratio tests and information criteria indicated that models in which (the logit of) hazard is a linear function of treatment did not yield a significantly worse fit than the saturated model [response: v 2 (7) = 57, p = 66; remission 1: v 2 () = 722, p = 51; remission 7: v 2 () = 596, p = 65] Consequently, these models were adopted These analyses were complemented by Kaplan-Meier survival analysis and CoxÕs regression models (stratified to control for electrode position) The latter analyses yielded similar results and are not reported for reasons of brevity To examine differences between patients with UP and BP depression in HRSD, BDI, CGI, and PGI scores at baseline, last treatment, and one and six weeks after the course of the treatment, repeated-measures analyses were performed Results Participant flow Eighty-one patients were randomized A total of 17 patients (UP, n = 13; BP, n = 4) did not complete the study protocol Nine patients (111%), four of whom were BP, refused further treatment before achieving remission and dropped out after a mean HDRS decrease of 337% (12 667%) In three patients, electrode placement was changed to bitemporal after 6 sessions because of sustained suicidality In one patient, right UL placement was changed to left UL placement because of sustained disorientation In four patients, the course was interrupted due to medical problems (bradycardia, pulmonary embolism) or complications (delirium, recurrent postictal agitation treated by a change of the anesthetic regimen to propofol) Sixty-four patients completed the study Of the completers, 51 (797%) patients had a diagnosis of UP depressive disorder, and 13 (23%) had a diagnosis of BP depressive disorder Table 1 lists demographic and clinical characteristics of participants The two groups did not differ in age or the distributions of gender, history of past ECT, number of days free of antidepressants, presence of psychotic (delusional) symptoms, and distribution of electrode position Patients in the BP group had a higher number of previous hospitalizations (523 ± 3 versus 339 ± 279; W = 5595, p = 2) In addition, patients given BF and UL ECT did not differ in baseline HRSD [t(62) = )55, p = 59], BDI [t(14) = )141, p = 1], CGI [t(146) = )67, p = 51], and PGI scores (W = 325, p = 9) Efficacy: response and remission Percentages of patients achieving the predefined end-point criteria are shown in Fig 1 Response criteria were met by 11 patients in the BP group (462%) and 39 patients in the UP group (7647%) (FisherÕs exact test, p = 72) Logistic regression analysis indicated that achieving response criteria could not be predicted by diagnosis [odds ratio (OR) = 17; 95% confidence Fig 1 Percentage of patients with bipolar (black bars) and unipolar (grey bars) depression achieving response remission Table 1 Demographic and clinical characteristics (n = 51) (n = 13) n % n % p value Male v 2 (1) = 12, p = 73 Psychotic FisherÕs exact, p = 73 Personality disorder v 2 (1) = 32, p = 57 Mean SD Mean SD Age t(62) = 2, p = 4 Number of previous hospitalizations W = 5595, p = 2 Age at first admission t(57) = 95, p = 34 Days free of antidepressants W = 456, p = 5 42

4 ECT in bipolar disorder interval (CI): ] or electrode position (OR = 95; 95% CI: ) Remitter-1 criteria were met by 9 patients (6923%) in the BP group and 33 patients (6471%) in the UP group (FisherÕs exact test, p = 1) Meeting remitter-1 criteria could not be predicted by diagnosis (OR = 12, 95% CI: ) or electrode position (OR = 174; 95% CI: ) Remitter-7 criteria were met by 7 patients (535%) in the BP group and 1 patients (3529%) in the UP group [v 2 (1) = 15, p = 22] Again, meeting remitter-7 criteria could not be predicted by diagnosis (OR = 21; 95% CI: ) or electrode position (OR = 1462; 95% CI: ) In the BP group, mean HRSD scores decreased from 25 ± 764 at baseline to 16 ± 911, 917 ± 671, and 969 ± 61 at the end of the treatment course and at one and six weeks after the treatment course, respectively In the UP group, mean HRSD scores decreased from 294 ± 536 at baseline to 112 ± 715, 1 ± 62, and 1149 ± 62 at the end of the treatment course and at one and six weeks after the treatment course, respectively HRSD scores decreased significantly over time in both BP and UP groups [main effect of time: F(3,153) = 145, p < 1] After controlling for electrode position, there were no significant differences between the two diagnostic groups [group: F(1,61) = 3, p = 59; group time: F(3,153) = 14, p = 94] In the BP group, mean BDI scores decreased significantly from 333 ± 136 at baseline to 14 ± 1725, 1433 ± 1567, and 12 ± 11 at the end of the treatment course and at one and six weeks after the treatment course, respectively; and in the UP group from 394 ± 92 at baseline to 152 ± 11, 1159 ± 979, and 146 ± 1116 at the end of the treatment course and at one and six weeks after the treatment course, respectively [main effect time: F(3,14) = 674, p < 1] Again, there were no significant differences between the two treatment groups [group: F(1,61) = 52, p = 47; group time: F(3,14) = 1, p = 49] In the BP group, mean CGI scores decreased significantly from 554 ± 113 at baseline to 27 ± 164, 217 ± 147, and 177 ± 3 at the end of the treatment course and at one and six weeks after the treatment course, respectively; and in the UP group from 576 ± 72 at baseline to 296 ± 123, 225 ± 124, and 217 ± 11 at the end of the treatment course and at one and six weeks after the treatment course, respectively [main effect time: F(3,14) = 152, p < 1] There were no significant differences between the two treatment groups [group: F(1,61) = 1, p = 37; group time: F(3,14) = 16, p = 92] In the BP group, mean PGI scores decreased from 623 ± 11 at baseline to 32 ± 23, 267 ± 27, and 215 ± 9 at the end of the treatment course and at one and six weeks after the treatment course, respectively; and in the UP group from 631 ± 79 at baseline to 352 ± 15, 256 ± 17, and 262 ± 121 at the end of the treatment course and at one and six weeks after the treatment course, respectively [main effect time: F(3,149) = 9317; p < 1] Again, there were no significant differences between the two treatment groups [group: F(1,61) = 5, p = 4; group time: F(3,149) = 34, p = ] Speed of response Patients in the BP group met response criteria after a mean of 69 ± 35 treatment sessions, significantly fewer than the number of treatment sessions in the UP group [95 ± 34; t(4) = 25, p = 5] Patients in the BP group had significantly fewer treatments sessions to achieve remitter-1 criteria than patients in the UP group: 79 ± 369 and 1152 ± 449, respectively [t(4) = 222, p = 3] There were no significant differences in the number of treatment sessions needed to meet remitter-7 criteria [971 ± 423 in the BP group, and 1161 ± 52 in the UP group; t(33) =, p = 39] In addition, discrete time hazard models were estimated to compare both groups, controlling for the effect of electrode position The estimated hazard and survivor functions of these models for response, remission 1, and remission 7 are depicted in Fig 2 For response, the estimated odds of meeting response criteria are 153 times higher at each additional clinical evaluation, ie, two additional treatment sessions (95% CI: 12 12) There was, however, no significant difference between the two diagnostic groups (OR = 13, 95% CI: 3 45, p = 14) The estimated odds of meeting remitter-1 criteria are 15 times higher for each additional clinical evaluation (95% CI: ) Again, there was no significant difference between the two diagnostic groups (OR = 19, 95% CI: 2 443, p = 14) The estimated odds of meeting remitter-7 criteria are 13 times higher for each additional evaluation (95% CI: ) There was a significant difference in estimated odds of meeting remitter-7 criteria between the BP and the UP group 421

5 H z a r d 4 a Fitted hazard function remission 1 v o r v S u 4 r i Fitted survivor function remission z a r d H 4 a Fitted hazard function remission 7 v o r S u v 4 r i Fitted survivor function remission H z a r d 4 a Fitted hazard function response v o r S u 4 i Sienaert et al Fitted survivor function response v r Fig 2 Discrete time hazard models: fitted hazard and survivor functions for remission 1, remission 7, and response (OR = 3; 95% CI: ) This effect remained significant after controlling for electrode position (OR = 17; 95% CI: 74 41) and number of previous admissions (OR = 96; 95% CI: 1 112) Cognitive side effects In the BP group, mean MMSE scores increased from 276 ± 2 at baseline to 2756 ± 261 and 252 ± 179 at one and six weeks after the treatment course, respectively; and in the UP group from 265 ± 261 at baseline to 267 ± 15 and 26 ± 134 at one and six weeks after the treatment course, respectively [main effect of time: F(2,59) = 174, p < 1] There was no main effect of group [F(1,59) = 13, p = 72] and no significant interaction between group and time [F(2,59) = 143, p = 24] Discussion The greatest unmet need in the clinical management of BP disorder is the acute and long-term treatment of depressive symptoms (2) There is growing evidence to discourage the use of antidepressants in the treatment of BP depression because of poor effectiveness (21) and possible destabilizing effects (22, 23) Treatment of BP 422 depression is often discouraging, with patients failing to achieve full remission (2, 24) About half of the patients experience residual depressive symptoms of at least two yearõs duration (25) As a result, patients spend the majority of time in the depressed phase of their illness (26, 27) and are prone to depressive relapse (25) ECT is a welcome treatment option for BP depression Our study further confirms antidepressant efficacy of ECT in BP depression, with response and remission rates as high as in UP depression Although response and remission rates in this study are high, even higher rates are reported in randomized trials using standard pulse (5 1 msec) bitemporal ECT (2) Our data corroborate the findings of Perris and dõelia (11) and Daly et al (12) that patients with BP depression tend to improve faster when treated with ECT than patients with UP depression In the Daly et al study (12), among initial responders the average number of treatments to first meet response criteria was 6 for UP patients and only 4 for BP patients (p < 1) In our study, the mean number of treatments to first meet response criteria was 9 for UP patients and 7 for BP patients (p = 5) The use of an ultra-brief pulse width might partly explain the higher number of treatments needed to achieve response remission than reported in trials using standard pulse width (12, 29, 3) In a recent study with a retrospective

6 ECT in bipolar disorder comparison group, patients treated with ultra-brief pulse UL ECT required a greater number of treatments to achieve response than patients treated with standard pulse UL ECT (3) In another prospective comparison of ultra-brief and standard pulse UL ECT, however, this was not the case (31) Another factor that might contribute to the higher number of treatments in this study is the lower frequency of evaluations In the Daly et al study (12), patients were evaluated at least twice weekly, whereas in this study patients were evaluated only once a week, thus having a lower number of time points to achieve response criteria In both the Daly et al study (12) and this study, BP patients had more rapid response to ECT independent of the clinical features that differentiate them from UP patients, and independent of the technique used What might account for the differences in speed of response remains speculative Daly et al (12) argue that aspects of psychopathology, such as the presence of personality disorder, could account for the differences in speed of response In their study, however, the presence of Axis II comorbidity was not assessed In this study, patients in the BP group had more Axis II comorbidity, although not to a statistically significant degree (Table 1) Since the presence of personality disorders predicts a diminished response to ECT (32), it cannot account for a better or faster response to ECT in patients with BP depression Another possible explanation for the difference in speed of response is a paradoxical shift to euthymia or hypomania after discontinuation of antidepressants in patients with BP depression The literature on this topic is scant, and euthymic hypo(manic) shifts have been described more frequently in UP (ie, no history of mania) than in BP patients (33, 34) Of the patients in the BP group, eight were treated with antidepressants (tricyclic antidepressant, n = 1; selective serotonin reuptake inhibitor, n = 3; serotonin norepinephrine reuptake inhibitor: n = 5) The phenomenon is thought to be more frequently seen after withdrawal of tricyclic antidepressants The only patient with BP depression treated with a tricyclic antidepressant was withdrawn eight days before starting ECT, and did not respond to ECT Moreover, Ôwithdrawal euthymiaõ (35), or antidepressant discontinuation-related (hypo)mania, is described to occur during or shortly after tapering (on average two weeks into the taper) (34), whereas response (not euthymia) in our BP sample occurred on average 45 weeks after antidepressant discontinuation Thus, it seems unlikely that withdrawal euthymia explains the faster response seen in patients with BP depression Whereas the use of antidepressants can induce hypomania or mania (22), or cycle acceleration (23), treatment-emergent mania or hypomania during ECT is rather uncommon (36) In our study, no treatment-emergent hypomania or mania was noted, although it was not assessed in a systematic way Thus, in line with the observations of Daly et al (12), the induction of hypomania cannot be responsible for a (rapid) antidepressant effect This study has a number of limitations The main focus of the study was to compare two electrode positions (13), and subjects were randomized accordingly Randomization was not stratified on diagnosis, so the inadvertent malrandomization of unmeasured confounds could have influenced the results The small number of subjects is another limitation of this study Finding a significant difference in speed of response in a lowpowered study, however, strengthens the significance of these results Conclusion Patients with BP and UP depression did not differ in rates of response or remission following an ECT course Patients with BP depression, however, showed a more rapid response than patients with UP depression Treatment of BP depression is a major challenge to the clinician Since patients with BP depression do respond to ECT as well as, and perhaps faster than patients with UP depression, ECT should be considered earlier in the treatment course References 1 UK ECT Review Group Efficacy and safety of electroconvulsive therapy in depressive disorders: a systematic review and meta-analysis Lancet 23; 361: Grunhaus L, Schreiber S, Dolberg OT, Hirshman S, Dannon PN Response to ECT in major depression: are there differences between unipolar and bipolar depression? 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