RENERIO FRAGUAS JUNIOR
Projetos de Pesquisa
Unidades Organizacionais
Departamento de Psiquiatria, Faculdade de Medicina - Docente
LIM/21 - Laboratório de Neuroimagem em Psiquiatria, Hospital das Clínicas, Faculdade de Medicina - Líder
LIM/21 - Laboratório de Neuroimagem em Psiquiatria, Hospital das Clínicas, Faculdade de Medicina - Líder
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- Efficacy and Safety of Transcranial Direct Current Stimulation as an Add-on Treatment for Bipolar Depression A Randomized Clinical Trial(2018) SAMPAIO-JUNIOR, Bernardo; TORTELLA, Gabriel; BORRIONE, Lucas; MOFFA, Adriano H.; MACHADO-VIEIRA, Rodrigo; CRETAZ, Eric; SILVA, Adriano Fernandes da; FRAGUAS, Renerio; APARICIO, Luana V.; KLEIN, Izio; LAFER, Beny; GOERIGK, Stephan; BENSENOR, Isabela Martins; LOTUFO, Paulo Andrade; GATTAZ, Wagner F.; BRUNONI, Andre RussowskyIMPORTANCE More effective, tolerable interventions for bipolar depression treatment are needed. Transcranial direct current stimulation (tDCS) is a novel therapeutic modality with few severe adverse events that showed promising results for unipolar depression. OBJECTIVE To determine the efficacy and safety of tDCS as an add-on treatment for bipolar depression. DESIGN, SETTING, AND PARTICIPANTS A randomized, sham-controlled, double-blind trial (the Bipolar Depression Electrical Treatment Trial [BETTER]) was conducted from July 1, 2014, to March 30, 2016, at an outpatient, single-center academic setting. Participants included 59 adults with type I or II bipolar disorder in a major depressive episode and receiving a stable pharmacologic regimen with 17-item Hamilton Depression Rating Scale (HDRS-17) scores higher than 17. Data were analyzed in the intention-to-treat sample. INTERVENTIONS Ten daily 30-minute, 2-mA, anodal-left and cathodal-right prefrontal sessions of active or sham tDCS on weekdays and then 1 session every fortnight until week 6. MAIN OUTCOMES AND MEASURES Change in HDRS-17 scores at week 6. RESULTS Fifty-nine patients (40 [68%] women), with a mean (SD) age of 45.9 (12) years participated; 36 (61%) with bipolar I and 23 (39%) with bipolar II disorder were randomized and 52 finished the trial. In the intention-to-treat analysis, patients in the active tDCS condition showed significantly superior improvement compared with those receiving sham (beta(int) = -1.68; number needed to treat, 5.8; 95% CI, 3.3-25.8; P = .01). Cumulative response rates were higher in the active vs sham groups (67.6% vs 30.4%; number needed to treat, 2.69; 95% CI, 1.84-4.99; P = .01), but not remission rates (37.4% vs 19.1%; number needed to treat, 5.46; 95% CI, 3.38-14.2; P = .18). Adverse events, including treatment-emergent affective switches, were similar between groups, except for localized skin redness that was higher in the active group (54% vs 19%; P = .01). CONCLUSIONS AND RELEVANCE In this trial, tDCS was an effective, safe, and tolerable add-on intervention for this small bipolar depression sample. Further trials should examine tDCS efficacy in a larger sample.
- Cognitive changes after tDCS and escitalopram treatment in major depressive disorder: Results from the placebo-controlled ELECT-TDCS trial(2020) MORENO, Marina L.; GOERIGK, Stephan A.; BERTOLA, Laiss; SUEMOTO, Claudia K.; RAZZA, Lais B.; MOFFA, Adriano H.; VERONEZI, Beatriz P.; TORT, Luara; NOGUEIRA, Barbara S.; GATTAZ, Wagner F.; FRAGUAS, Renerio; PADBERG, Frank; LOTUFO, Paulo A.; BENSENOR, Isabela M.; BRUNONI, Andre R.Background: Cognitive deficits in major depressive disorder (MDD) are associated with low quality of life and higher suicide risk. Antidepressant drugs have modest to null effects in improving such deficits. Therefore, we investigated the cognitive effects of transcranial direct current stimulation (tDCS), which is a promising antidepressant non-pharmacological intervention, in MDD. Methods: An exploratory analysis on cognitive performance was conducted in 243 depressed patients from the Escitalopram vs. Electric Current Therapy for Treating Depression Clinical Study (ELECT-TDCS), a sham-controlled study comparing the efficacy of tDCS vs. escitalopram. A neuropsychological battery was applied at baseline and endpoint (10 weeks of treatment) to create composite cognitive scores (processing speed, working memory, and verbal fluency). Linear mixed regression models were used to evaluate changes according to intervention groups, adjusted for confounding variables (age, years of schooling, gender, and benzodiazepine use) and depression improvement. Results: No cognitive deterioration was observed in any group. Patients receiving tDCS presented reduced practice gains compared to placebo in processing speed. In patients receiving escitalopram vs. placebo and in the subgroup of clinical responders ( > 50% depression improvement from baseline), those receiving tDCS vs. placebo presented increased performance in verbal fluency. No significant differences between tDCS and escitalopram groups were detected. Limitations: Absence of healthy controls. Conclusion: Prefrontal tDCS did not lead to cognitive deficits in depressed patients, although it reduced practice effects in processing speed. tDCS responders presented increased performance in verbal fluency. Further investigation of tDCS cognitive effects in depression is warranted.
- Loss of interest, depressed mood and impact on the quality of life: Cross-sectional survey(2011) GUAJARDO, Valeri D.; SOUZA, Bruno P. F.; HENRIQUES, Sergio G.; LUCIA, Mara C. S.; MENEZES, Paulo R.; MARTINS, Milton A.; TARDIVO, Leila S. L. P. C.; GATTAZ, Wagner F.; FRAGUAS, RenerioBackground: Depressive symptoms and chronic disease have adverse effects on patients' health-related quality of life (H-RQOL). However, little is known about this effect on H-RQOL when only the two core depressive symptoms - loss of interest and depressed mood - are considered. The objective of this study is to investigate H-RQOL in the presence of loss of interest and depressed mood at a general medical outpatient unit. Methods: We evaluated 553 patients at their first attendance at a general medical outpatient unit of a teaching hospital. H-RQOL was assessed with the Medical Outcomes Study 36-item Short-Form Health Survey (SF-36). Depressed mood and loss of interest were assessed by the Primary Care Evaluation of Mental Disorders (PRIME-MD)Patient Questionnaire. A physician performed the diagnosis of chronic diseases by clinical judgment and classified them in 13 possible pre-defined categories. We used multiple linear regression to investigate associations between each domain of H-RQOL and our two core depression symptoms. The presence of chronic diseases and demographic variables were included in the models as covariates. Results: Among the 553 patients, 70.5% were women with a mean age of 41.0 years (range 18-85, SD +/- 15.4). Loss of interest was reported by 54.6%, and depressed mood by 59.7% of the patients. At least one chronic disease was diagnosed in 59.5% of patients; cardiovascular disease was the most prevalent, affecting 20.6% of our patients. Loss of interest and depressed mood was significantly associated with decreased scores in all domains of H-RQOL after adjustment for possible confounders. The presence of any chronic disease was associated with a decrease in the domain of vitality. The analysis of each individual chronic disease category revealed that no category was associated with a decrease in more than one domain of H-RQOL. Conclusion: Loss of interest and depressed mood were associated with significant decreases in H-RQOL. We recommend these simple tests for screening in general practice.
- Precision non-implantable neuromodulation therapies: a perspective for the depressed brain(2020) BORRIONE, Lucas; BELLINI, Helena; RAZZA, Lais Boralli; AVILA, Ana G.; BAEKEN, Chris; BREM, Anna-Katharine; BUSATTO, Geraldo; CARVALHO, Andre F.; CHEKROUD, Adam; DASKALAKIS, Zafiris J.; DENG, Zhi-De; DOWNAR, Jonathan; GATTAZ, Wagner; LOO, Colleen; LOTUFO, Paulo A.; MARTIN, Maria da Graca M.; MCCLINTOCK, Shawn M.; O'SHEA, Jacinta; PADBERG, Frank; PASSOS, Ives C.; SALUM, Giovanni A.; VANDERHASSELT, Marie-Anne; FRAGUAS, Renerio; BENSENOR, Isabela; VALIENGO, Leandro; BRUNONI, Andre R.Current first-line treatments for major depressive disorder (MDD) include pharmacotherapy and cognitive-behavioral therapy. However, one-third of depressed patients do not achieve remission after multiple medication trials, and psychotherapy can be costly and time-consuming. Although non-implantable neuromodulation (NIN) techniques such as transcranial magnetic stimulation, transcranial direct current stimulation, electroconvulsive therapy, and magnetic seizure therapy are gaining momentum for treating MDD, the efficacy of non-convulsive techniques is still modest, whereas use of convulsive modalities is limited by their cognitive side effects. In this context, we propose that NIN techniques could benefit from a precision-oriented approach. In this review, we discuss the challenges and opportunities in implementing such a framework, focusing on enhancing NIN effects via a combination of individualized cognitive interventions, using closed-loop approaches, identifying multimodal biomarkers, using computer electric field modeling to guide targeting and quantify dosage, and using machine learning algorithms to integrate data collected at multiple biological levels and identify clinical responders. Though promising, this framework is currently limited, as previous studies have employed small samples and did not sufficiently explore pathophysiological mechanisms associated with NIN response and side effects. Moreover, cost-effectiveness analyses have not been performed. Nevertheless, further advancements in clinical trials of NIN could shift the field toward a more ""precision-oriented"" practice.
- Transcranial direct current stimulation (tDCS) for preventing major depressive disorder relapse: Results of a 6-month follow-up(2019) APARICIO, Luana V. M.; ROSA, Vivianne; RAZZA, Lais M.; SAMPAIO-JUNIOR, Bernardo; BORRIONE, Lucas; VALIENGO, Leandro; LOTUFO, Paulo A.; BENSENOR, Isabela M.; FRAGUAS, Renerio; MOFFA, Adriano H.; GATTAZ, Wagner F.; BRUNONI, Andre RussowskyBackgroundThe efficacy of transcranial direct current stimulation (tDCS) as a continuation therapy for the maintenance phase of the depressive episode is low and insufficiently investigated in literature. We investigated whether it could be enhanced by using a more intensive treatment regimen compared to previous reports. MethodsTwenty-four patients (16 with unipolar depression and eight with bipolar depression) who presented acute tDCS response (50% depression improvement in the Hamilton Depression Rating Scale [HDRS]) after receiving 15 tDCS sessions were followed for up to 6 months or until relapse, defined as clinical worsening and/or HDRS>15. Sessions were performed twice a week (maximum of 48 sessions) over 24weeks. The anode and the cathode were positioned over the left and right dorsolateral prefrontal cortex (2mA current, 30 min sessions were delivered). We performed Kaplan-Meier survival analysis and Cox proportional hazards ratios to evaluate predictors of relapse. ResultsOut of 24 patients, 18 completed the follow-up period. tDCS treatment was well tolerated. The mean survival duration was 17.5weeks (122 days). The survival rate at the end of follow-up was 73.5% (95% confidence interval, 50-87). A trend (P=0.09) was observed for lower relapse rates in nontreatment- vs. antidepressant treatment-resistant patients (7.7%vs. 45.5%, respectively). No differences in efficacy between unipolar and bipolar depression were observed. ConclusionAn intensive tDCS treatment regimen consisting of sessions twice a week achieved relatively low relapse rates after a 6-month follow up of tDCS responders, particularly for nontreatment-resistant patients.
- Trial of Electrical Direct-Current Therapy versus Escitalopram for Depression(2017) BRUNONI, A. R.; MOFFA, A. H.; SAMPAIO-JUNIOR, B.; BORRIONE, L.; MORENO, M. L.; FERNANDES, R. A.; VERONEZI, B. P.; NOGUEIRA, B. S.; APARICIO, L. V. M.; RAZZA, L. B.; CHAMORRO, R.; TORT, L. C.; FRAGUAS, R.; LOTUFO, P. A.; GATTAZ, W. F.; FREGNI, F.; BENSENOR, I. M.BACKGROUND We compared transcranial direct-current stimulation (tDCS) with a selective serotonin-reuptake inhibitor for the treatment of depression. METHODS In a single-center, double-blind, noninferiority trial involving adults with unipolar depression, we randomly assigned patients to receive tDCS plus oral placebo, sham tDCS plus escitalopram, or sham tDCS plus oral placebo. The tDCS was administered in 30-minute, 2-mA prefrontal stimulation sessions for 15 consecutive weekdays, followed by 7 weekly treatments. Escitalopram was given at a dose of 10 mg per day for 3 weeks and 20 mg per day thereafter. The primary outcome measure was the change in the 17-item Hamilton Depression Rating Scale (HDRS-17) score (range, 0 to 52, with higher scores indicating more depression). Noninferiority of tDCS versus escitalopram was defined by a lower boundary of the confidence interval for the difference in the decreased score that was at least 50% of the difference in the scores with placebo versus escitalopram. RESULTS A total of 245 patients underwent randomization, with 91 being assigned to escitalopram, 94 to tDCS, and 60 to placebo. In the intention-to-treat analysis, the mean (+/- SD) decrease in the score from baseline was 11.3 +/- 6.5 points in the escitalopram group, 9.0 +/- 7.1 points in the tDCS group, and 5.8 +/- 7.9 points in the placebo group. The lower boundary of the confidence interval for the difference in the decrease for tDCS versus escitalopram (difference, -2.3 points; 95% confidence interval [CI], -4.3 to -0.4; P = 0.69) was lower than the noninferiority margin of -2.75 (50% of placebo minus escitalopram), so noninferiority could not be claimed. Escitalopram and tDCS were both superior to placebo (difference vs. placebo, 5.5 points [95% CI, 3.1 to 7.8; P<0.001] and 3.2 points [95% CI, 0.7 to 5.5; P = 0.01], respectively). Patients receiving tDCS had higher rates of skin redness, tinnitus, and nervousness than did those in the other two groups, and new-onset mania developed in 2 patients in the tDCS group. Patients receiving escitalopram had more frequent sleepiness and obstipation than did those in the other two groups. CONCLUSIONS In a single-center trial, tDCS for the treatment of depression did not show noninferiority to escitalopram over a 10-week period and was associated with more adverse events. (Funded by Fundacao de Amparo a Pesquisa do Estado de Sao Paulo and others; ELECT-TDCS ClinicalTrials.gov number, NCT01894815.)