Revista brasileira de psiquiatria (Sao Paulo, Brazil : 1999) · 2014
Design and rationale of a 16-week adjunctive randomized placebo-controlled trial of mitochondrial agents for the treatment of bipolar depression.
СтатьяМногоцентровое исследованиеРандомизированное исследованиеПоддержка NIH: внешняя программаПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Dean Olivia M, Turner Alyna, Malhi Gin S, Ng Chee, Cotton Sue M, Dodd Seetal, Sarris Jerome, Samuni Yuval, Tanious Michelle, Dowling Nathan, Waterdrinker Astrid, Smith Deidre, Berk Michael
Аннотация
OBJECTIVE: Bipolar disorder places a significant burden on individuals, caregivers and family, and the broader community. Current treatments are believed to be more effective against manic symptoms, leaving a shortfall in recovery during the depressive phase of the illness. The current study draws on recent evidence suggesting that, in addition to increased oxidative load, alterations in mitochondrial function occur in bipolar disorder.
METHODS: This 16-week study aims to explore the potential benefits of N-acetylcysteine (NAC) alone or in combination (CT) with selected nutraceuticals believed to enhance mitochondrial function. The study includes adults diagnosed with bipolar disorder currently experiencing an episode of depression. Participants are asked to take NAC, CT, or placebo in addition to any usual treatments. A post-discontinuation visit is conducted 4 weeks following the treatment phase.
RESULTS: The primary outcome of the study will be mean change on the Montgomery-Asberg Depression Rating Scale. Secondary outcomes include functioning, substance use, mania ratings, and quality of life. Blood samples will be collected at baseline and week 16 to explore biochemical alterations following treatment.
CONCLUSION: This study may provide a novel adjunctive treatment for bipolar depression. Analysis of biological samples may assist in understanding the therapeutic benefits and the underlying etiology of bipolar depression.
TRIAL REGISTRATION: Australian and New Zealand Clinical Trial Registry ACTRN12612000830897.
METHODS: This 16-week study aims to explore the potential benefits of N-acetylcysteine (NAC) alone or in combination (CT) with selected nutraceuticals believed to enhance mitochondrial function. The study includes adults diagnosed with bipolar disorder currently experiencing an episode of depression. Participants are asked to take NAC, CT, or placebo in addition to any usual treatments. A post-discontinuation visit is conducted 4 weeks following the treatment phase.
RESULTS: The primary outcome of the study will be mean change on the Montgomery-Asberg Depression Rating Scale. Secondary outcomes include functioning, substance use, mania ratings, and quality of life. Blood samples will be collected at baseline and week 16 to explore biochemical alterations following treatment.
CONCLUSION: This study may provide a novel adjunctive treatment for bipolar depression. Analysis of biological samples may assist in understanding the therapeutic benefits and the underlying etiology of bipolar depression.
TRIAL REGISTRATION: Australian and New Zealand Clinical Trial Registry ACTRN12612000830897.
Предметные рубрики MeSH
AcetylcysteineAdultAntidepressive AgentsAntioxidantsBipolar DisorderCombined Modality TherapyDepressive DisorderDietary SupplementsDose-Response Relationship, DrugDouble-Blind MethodFemaleFree Radical ScavengersHumansMaleMitochondriaMitochondrial DiseasesPlacebosPsychiatric Status Rating ScalesStatistics, NonparametricTime FactorsTreatment OutcomeUbiquinoneVitamin K 3Vitamins