Design and rationale of a 16-week adjunctive randomized placebo-controlled trial of mitochondrial agents for the treatment of bipolar depression

Detalhes bibliográficos
Autor(a) principal: Dean,Olivia M.
Data de Publicação: 2015
Outros Autores: 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
Tipo de documento: Artigo
Idioma: eng
Título da fonte: Brazilian Journal of Psychiatry (São Paulo. 1999. Online)
Texto Completo: http://old.scielo.br/scielo.php?script=sci_arttext&pid=S1516-44462015000100003
Resumo: 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.
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spelling Design and rationale of a 16-week adjunctive randomized placebo-controlled trial of mitochondrial agents for the treatment of bipolar depressionMitochondriabipolar disorderdepressionacetylcysteineoxidative stress 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. Associação Brasileira de Psiquiatria2015-03-01info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersiontext/htmlhttp://old.scielo.br/scielo.php?script=sci_arttext&pid=S1516-44462015000100003Brazilian Journal of Psychiatry v.37 n.1 2015reponame:Brazilian Journal of Psychiatry (São Paulo. 1999. Online)instname:Associação Brasileira de Psiquiatria (ABP)instacron:ABP10.1590/1516-4446-2013-1341info:eu-repo/semantics/openAccessDean,Olivia M.Turner,AlynaMalhi,Gin S.Ng,CheeCotton,Sue M.Dodd,SeetalSarris,JeromeSamuni,YuvalTanious,MichelleDowling,NathanWaterdrinker,AstridSmith,DeidreBerk,Michaeleng2015-03-19T00:00:00Zoai:scielo:S1516-44462015000100003Revistahttp://www.bjp.org.br/ahead_of_print.asphttps://old.scielo.br/oai/scielo-oai.php||rbp@abpbrasil.org.br1809-452X1516-4446opendoar:2015-03-19T00:00Brazilian Journal of Psychiatry (São Paulo. 1999. Online) - Associação Brasileira de Psiquiatria (ABP)false
dc.title.none.fl_str_mv Design and rationale of a 16-week adjunctive randomized placebo-controlled trial of mitochondrial agents for the treatment of bipolar depression
title Design and rationale of a 16-week adjunctive randomized placebo-controlled trial of mitochondrial agents for the treatment of bipolar depression
spellingShingle Design and rationale of a 16-week adjunctive randomized placebo-controlled trial of mitochondrial agents for the treatment of bipolar depression
Dean,Olivia M.
Mitochondria
bipolar disorder
depression
acetylcysteine
oxidative stress
title_short Design and rationale of a 16-week adjunctive randomized placebo-controlled trial of mitochondrial agents for the treatment of bipolar depression
title_full Design and rationale of a 16-week adjunctive randomized placebo-controlled trial of mitochondrial agents for the treatment of bipolar depression
title_fullStr Design and rationale of a 16-week adjunctive randomized placebo-controlled trial of mitochondrial agents for the treatment of bipolar depression
title_full_unstemmed Design and rationale of a 16-week adjunctive randomized placebo-controlled trial of mitochondrial agents for the treatment of bipolar depression
title_sort Design and rationale of a 16-week adjunctive randomized placebo-controlled trial of mitochondrial agents for the treatment of bipolar depression
author Dean,Olivia M.
author_facet 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
author_role author
author2 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
author2_role author
author
author
author
author
author
author
author
author
author
author
author
dc.contributor.author.fl_str_mv 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
dc.subject.por.fl_str_mv Mitochondria
bipolar disorder
depression
acetylcysteine
oxidative stress
topic Mitochondria
bipolar disorder
depression
acetylcysteine
oxidative stress
description 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.
publishDate 2015
dc.date.none.fl_str_mv 2015-03-01
dc.type.driver.fl_str_mv info:eu-repo/semantics/article
dc.type.status.fl_str_mv info:eu-repo/semantics/publishedVersion
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dc.language.iso.fl_str_mv eng
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dc.relation.none.fl_str_mv 10.1590/1516-4446-2013-1341
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eu_rights_str_mv openAccess
dc.format.none.fl_str_mv text/html
dc.publisher.none.fl_str_mv Associação Brasileira de Psiquiatria
publisher.none.fl_str_mv Associação Brasileira de Psiquiatria
dc.source.none.fl_str_mv Brazilian Journal of Psychiatry v.37 n.1 2015
reponame:Brazilian Journal of Psychiatry (São Paulo. 1999. Online)
instname:Associação Brasileira de Psiquiatria (ABP)
instacron:ABP
instname_str Associação Brasileira de Psiquiatria (ABP)
instacron_str ABP
institution ABP
reponame_str Brazilian Journal of Psychiatry (São Paulo. 1999. Online)
collection Brazilian Journal of Psychiatry (São Paulo. 1999. Online)
repository.name.fl_str_mv Brazilian Journal of Psychiatry (São Paulo. 1999. Online) - Associação Brasileira de Psiquiatria (ABP)
repository.mail.fl_str_mv ||rbp@abpbrasil.org.br
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