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.
RCT Entities:
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.
Authors: Melanie M Ashton; Mohammadreza Mohebbi; Alyna Turner; Wolfgang Marx; Michael Berk; Gin S Malhi; Chee H Ng; Sue M Cotton; Seetal Dodd; Jerome Sarris; Malcolm Hopwood; Brendon Stubbs; Olivia M Dean Journal: Can J Psychiatry Date: 2019-11-28 Impact factor: 4.356
Authors: Scott D Adams; Abbas Z Kouzani; Susannah J Tye; Kevin E Bennet; Michael Berk Journal: J Neuroeng Rehabil Date: 2018-02-13 Impact factor: 4.262
Authors: G Scaini; G R Fries; S S Valvassori; C P Zeni; G Zunta-Soares; M Berk; J C Soares; J Quevedo Journal: Transl Psychiatry Date: 2017-05-02 Impact factor: 6.222
Authors: Círia Pereira; Victor Chavarria; João Vian; Melanie Maree Ashton; Michael Berk; Wolfgang Marx; Olivia May Dean Journal: Int J Neuropsychopharmacol Date: 2018-06-01 Impact factor: 5.176
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