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

Olivia M. Dean; Alyna Turner; Gin S. Malhi; Chee Ng; Sue M. Cotton; Seetal Dodd; Jerome Sarris; Yuval Samuni; Michelle Tanious; Nathan Dowling; Astrid Waterdrinker; Deidre Smith; Michael Berk

doi:10.1590/1516-4446-2013-1341

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

Olivia M. Dean, Alyna Turner, Gin S. Malhi, Chee Ng, Sue M. Cotton, Seetal Dodd, Jerome Sarris, Yuval Samuni, Michelle Tanious, Nathan Dowling, Astrid Waterdrinker, Deidre Smith, Michael Berk

Western Sydney University

Research output: Contribution to journal › Article › peer-review

38 Citations (Scopus)

Abstract

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 postdiscontinuation 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.

Original language	English
Pages (from-to)	3-12
Number of pages	10
Journal	Revista Brasileira de Psiquiatria
Volume	37
Issue number	1
DOIs	https://doi.org/10.1590/1516-4446-2013-1341
Publication status	Published - 2015

Open Access - Access Right Statement

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License, which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

Keywords

depression
manic, depressive illness
mitochondria
oxidative stress
randomized controlled trials
treatment

Access to Document

10.1590/1516-4446-2013-1341

Cite this

Dean, O. M., Turner, A., Malhi, G. S., Ng, C., Cotton, S. M., Dodd, S., Sarris, J., Samuni, Y., Tanious, M., Dowling, N., Waterdrinker, A., Smith, D., & Berk, M. (2015). Design and rationale of a 16-week adjunctive randomized placebo-controlled trial of mitochondrial agents for the treatment of bipolar depression. Revista Brasileira de Psiquiatria, 37(1), 3-12. https://doi.org/10.1590/1516-4446-2013-1341

@article{14052bb0494e455387bfe017cb237da8,

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

abstract = "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 postdiscontinuation 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.",

keywords = "depression, manic, depressive illness, mitochondria, oxidative stress, randomized controlled trials, treatment",

author = "Dean, {Olivia M.} and Alyna Turner and Malhi, {Gin S.} and Chee Ng and Cotton, {Sue M.} and Seetal Dodd and Jerome Sarris and Yuval Samuni and Michelle Tanious and Nathan Dowling and Astrid Waterdrinker and Deidre Smith and Michael Berk",

year = "2015",

doi = "10.1590/1516-4446-2013-1341",

language = "English",

volume = "37",

pages = "3--12",

journal = "Revista Brasileira de Psiquiatria",

issn = "1516-4446",

publisher = "Associacao Brasileira de Psiquiatria",

number = "1",

}

Dean, OM, Turner, A, Malhi, GS, Ng, C, Cotton, SM, Dodd, S, Sarris, J, Samuni, Y, Tanious, M, Dowling, N, Waterdrinker, A, Smith, D & Berk, M 2015, 'Design and rationale of a 16-week adjunctive randomized placebo-controlled trial of mitochondrial agents for the treatment of bipolar depression', Revista Brasileira de Psiquiatria, vol. 37, no. 1, pp. 3-12. https://doi.org/10.1590/1516-4446-2013-1341

TY - JOUR

T1 - Design and rationale of a 16-week adjunctive randomized placebo-controlled trial of mitochondrial agents for the treatment of bipolar depression

AU - Dean, Olivia M.

AU - Turner, Alyna

AU - Malhi, Gin S.

AU - Ng, Chee

AU - Cotton, Sue M.

AU - Dodd, Seetal

AU - Sarris, Jerome

AU - Samuni, Yuval

AU - Tanious, Michelle

AU - Dowling, Nathan

AU - Waterdrinker, Astrid

AU - Smith, Deidre

AU - Berk, Michael

PY - 2015

Y1 - 2015

N2 - 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 postdiscontinuation 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.

AB - 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 postdiscontinuation 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.

KW - depression

KW - manic, depressive illness

KW - mitochondria

KW - oxidative stress

KW - randomized controlled trials

KW - treatment

UR - http://handle.westernsydney.edu.au:8081/1959.7/uws:39481

U2 - 10.1590/1516-4446-2013-1341

DO - 10.1590/1516-4446-2013-1341

M3 - Article

SN - 1516-4446

VL - 37

SP - 3

EP - 12

JO - Revista Brasileira de Psiquiatria

JF - Revista Brasileira de Psiquiatria

IS - 1

ER -

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

Abstract

Open Access - Access Right Statement

Keywords

Access to Document

Other files and links

Fingerprint

Cite this