MICHELLE DA SILVA

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3
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Instituto de Psiquiatria, Hospital das Clínicas, Faculdade de Medicina
LIM/21 - Laboratório de Neuroimagem em Psiquiatria, Hospital das Clínicas, Faculdade de Medicina

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  • article 23 Citação(ões) na Scopus
    A randomized, double-blind, placebo-controlled, proof-of-concept trial of creatine monohydrate as adjunctive treatment for bipolar depression
    (2018) TONIOLO, Ricardo Alexandre; SILVA, Michelle; FERNANDES, Francy de Brito Ferreira; AMARAL, Jose Antonio de Mello Siqueira; DIAS, Rodrigo da Silva; LAFER, Beny
    Depressive episodes are a major cause of morbidity and dysfunction in individuals suffering from bipolar disorder. Currently available treatments for this condition have limited efficacy and new therapeutic options are needed. Extensive research in the pathophysiology of bipolar disorder points to the existence of mitochondrial and bioenergetic dysfunction. We hypothesized that creatine monohydrate, a nutraceutical that works as a mitochondrial modulator, would be effective as an adjunctive therapy for bipolar depression. We conducted a double-blind trial in which 35 patients with bipolar disorder type I or II in a depressive episode by DSM-IV criteria and in use of regular medication for the treatment of this phase of the disease were randomly allocated into two adjunctive treatment groups for 6 weeks: creatine monohydrate 6 g daily (N = 17) or placebo (N = 18). Primary efficacy was assessed by the change in the Montgomery-sberg Depression Rating Scale (MADRS). We did not find a statistically significant difference in the comparison between groups for the change in score on the MADRS after 6 weeks in an intention-to-treat (ITT) analysis (p = 0.560; Cohen's d = 0.231). However, we found significant superiority of creatine add-on vs. placebo when we considered the remission criterion of a MADRS score ae 12 at week 6 analyzing the outcome of the 35 randomized patients on ITT (52.9% remission in the creatine group vs. 11.1% remission in the placebo group) and of the 23 completers (66.7% remission in the creatine group vs. 18.2% remission in the placebo group) (p = 0.012; OR = 9.0 and p = 0.036; OR = 9.0, respectively). Two patients who received creatine switched to hypomania/mania early in the trial. No clinically relevant physical side-effects were reported or observed. This proof-of-concept study, aiming to restore brain bioenergetics using an adjunctive mitochondrial modulator, is not conclusive on the efficacy of creatine add-on for bipolar depression, but suggests that this compound may have a role in the adjunctive treatment of this phase of the illness. Further investigation through randomized controlled trials with larger samples should be conducted to verify the efficacy of creatine supplementation for bipolar depression and also for subsyndromal depressive symptoms.
  • article 13 Citação(ões) na Scopus
    Impact of predominant polarity on long-term outcome in bipolar disorder: A 7-year longitudinal cohort study
    (2018) BELIZARIO, Gabriel Okawa; SILVA, Michelle; LAFER, Beny
    Introduction: Recent studies suggest that Predominant Polarity (PP) may be an important specifier of Bipolar Disorder (BD), establishing distinct groups of patients and providing a potential tool for tailored treatment. PP has been associated to various clinical variables present in the course of the disorder, including deficits in cognitive functioning, suicide attempts, hospitalizations and response to pharmacological treatment. However, most published studies are retrospective and cross-sectional, frequently relying on patients' ability to recall past information, which may often be inaccurate. Methods: Participants were recruited from the outpatient clinic of the Bipolar Disorder Research Program at the Institute of Psychiatry of the University of Sao Paulo. Baseline clinical and demographic variables were collected using a semi-structured questionnaire and the SCID-CV. Longitudinal data were collected through medical records, mood charts, and mood symptom scales conducted throughout a 7-year follow-up period. Results: Manic Predominant Polarity (MPP) was associated with a significantly higher number of hospitalizations, suicide attempts, and episodes with psychotic symptoms throughout the 7-year observed period in comparison to Depressive Predominant Polarity (DPP) and Indefinite Predominant Polarity (IPP) patients. Moreover, baseline PP was significantly associated with 7-year PP, with 67% of patients maintaining their PP both at baseline and after the 7-year follow-up period. Limitations: The present study is limited due to the statistically small sample size, although, to our knowledge, it is the largest longitudinal study conducted in this topic, and the unequally distributed frequency of patients' visitations, which may have created intervals of unobserved periods within the follow-up period. Discussion: The results revealed PP to be an important specifier for predicting the course of the disorder. Overall, MPP was significantly associated with variables indicative of a worse outcome, suggesting that greater attention to preventive treatment should be addressed to this subgroup. Lastly, baseline PP was significantly associated with 7-year observed PP, suggesting that patients tend to remain within the same PP throughout the course of the disorder.