A randomized, double-blind, placebo-controlled, proof-of-concept trial of creatine monohydrate as adjunctive treatment for bipolar depression
Toniolo RA, Silva M, Fernandes FBF, Amaral JAMS, Dias RDS, Lafer B
Journal of neural transmission (Vienna, Austria : 1996) · 35 citas
Cómo se estudió
- Diseño
- Ensayo controlado aleatorizado (indexado por PubMed)
- Estudiado en
- Personas
- Resultado principal
- Marcadores de salud y funcionamiento
Quién lo pagó
- Financiación
- Financiación independiente
- Organización sin fines de lucro
- Brain and Behavior Research Foundation
- Gobierno
- Coordenação de Aperfeiçoamento de Pessoal de Nível Superior
- Subvenciones
- Brain and Behavior Research Foundation (20202)
Según 2 financiadores declarados y la declaración de financiación del texto completo.
Publicación
- Publicado
- 2017-11-24 · J Neural Transm (Vienna) · vol. 125 · número 2 · págs. 247–257
- Editorial
- Springer Science+Business Media
- Citado
- 47 citas · más que el 86% de estudios similares · 1.8× el promedio de su campo
- Referencias
- 55 trabajos
- Acceso
- Acceso abierto (revista híbrida) · CC-BY
- Áreas de investigación
- Bipolar Disorder and Treatment · Electroconvulsive Therapy Studies · Biochemical Acid Research Studies
- Palabras clave
- Depression (economics), Placebo, Double blind, Adjunctive treatment, Neurology, Randomized controlled trial, Bipolar disorder, Psychology, Psychiatry, Creatine, Medicine, Internal medicine, Psychotherapist, Lithium (medication), Alternative medicine, Pathology
- MeSH
- humans, creatine, antidepressive agents, antioxidants, double-blind method, bipolar disorder, dietary supplements, adult, middle aged, proof of concept study
6 autores
- Ricardo Alexandre Toniolo🇧🇷 · autor de correspondenciaHospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
- Michelle Silva🇧🇷Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
- Francy de Brito Ferreira Fernandes🇧🇷Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
- José Antônio Amaral🇧🇷Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
- Rodrigo da Silva Dias🇧🇷Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
- Beny Lafer🇧🇷Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
Resumen
El texto original del estudio, en el idioma en que se publicó.
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-Åsberg 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 ≤ 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.
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