Add-on treatment with N-acetylcysteine for bipolar depression: a 24-week randomized double-blind parallel group placebo-controlled multicentre trial (NACOS-study protocol)

Pernille Kempel Ellegaard; Rasmus Wentzer Licht; Henrik Enghusen Poulsen; René Ernst Nielsen; Michael Berk; Olivia May Dean; Mohammadreza Mohebbi; Connie Thuroee Nielsen

doi:10.1186/s40345-018-0117-9

Add-on treatment with N-acetylcysteine for bipolar depression: a 24-week randomized double-blind parallel group placebo-controlled multicentre trial (NACOS-study protocol)

Pernille Kempel Ellegaard^*, Rasmus Wentzer Licht, Henrik Enghusen Poulsen, René Ernst Nielsen, Michael Berk, Olivia May Dean, Mohammadreza Mohebbi, Connie Thuroee Nielsen

^*Corresponding author for this work

Department of Clinical Medicine

8 Citations (Scopus)

35 Downloads (Pure)

Abstract

Background: Oxidative stress and inflammation may be involved in the development and progression of mood disorders, including bipolar disorder. Currently, there is a scarcity of useful treatment options for bipolar depressive episodes, especially compared with the efficacy of treatment for acute mania. N-Acetylcysteine (NAC) has been explored for psychiatric disorders for some time given its antioxidant and anti-inflammatory properties. The current trial aims at testing the clinical effects of adjunctive NAC treatment (compared to placebo) for bipolar depression. We will also explore the biological effects of NAC in this context. We hypothesize that adjunctive NAC treatment will reduce symptoms of depression, which will be reflected by changes in selected markers of oxidative stress. Methods and analysis: In the study, we will include adults diagnosed with bipolar disorder, in a currently depressive episode. Participants will undertake a 20-week, adjunctive, randomized, double-blinded, parallel group placebo-controlled trial comparing 3 grams of adjunctive NAC daily with placebo. The primary outcome is the mean change over time from baseline to end of study on the Montgomery–Asberg Depression Rating Scale (MADRS). Among the secondary outcomes are mean changes from baseline to end of study on the Bech-Rafaelsen Melancholia Scale (MES), the Young Mania Rating Scale (YMRS), the WHO-Five Well-being Index (WHO-5), the Global Assessment of Functioning scale (GAF-F), the Global Assessment of Symptoms scale (GAF-S) and the Clinical Global Impression-Severity scale (CGI-S). The potential effects on oxidative stress by NAC treatment will be measured through urine and blood samples. DNA will be examined for potential polymorphisms related to oxidative defences. Trial registration: Registered at The European Clinical Trials Database, ClinicalTrials.gov: NCT02294591 and The Danish Data Protection Agency: 2008-58-0035.

Original language	English
Article number	11
Journal	International Journal of Bipolar Disorders
Volume	6
Issue number	1
ISSN	2194-7511
DOIs	https://doi.org/10.1186/s40345-018-0117-9
Publication status	Published - 2018

Keywords

Acetylcysteine
Bipolar disorder
Blood
Depression
Genetics
Inflammation
Oxidative stress
Psychiatry
Treatment
Urine

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Add-on treatment with N-acetylcysteine for bipolar depression: a 24-week randomized double-blind parallel group placebo-controlled multicentre trial (NACOS-study protocol)Final published version, 1.1 MBLicence: CC BY

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Ellegaard, P. K., Licht, R. W., Poulsen, H. E., Nielsen, R. E., Berk, M., Dean, O. M., Mohebbi, M., & Nielsen, C. T. (2018). Add-on treatment with N-acetylcysteine for bipolar depression: a 24-week randomized double-blind parallel group placebo-controlled multicentre trial (NACOS-study protocol). International Journal of Bipolar Disorders, 6(1), Article 11. https://doi.org/10.1186/s40345-018-0117-9

Add-on treatment with N-acetylcysteine for bipolar depression: a 24-week randomized double-blind parallel group placebo-controlled multicentre trial (NACOS-study protocol). / Ellegaard, Pernille Kempel; Licht, Rasmus Wentzer; Poulsen, Henrik Enghusen et al.
In: International Journal of Bipolar Disorders, Vol. 6, No. 1, 11, 2018.

Research output: Contribution to journal › Journal article › Research › peer-review

Ellegaard, PK, Licht, RW, Poulsen, HE, Nielsen, RE, Berk, M, Dean, OM, Mohebbi, M & Nielsen, CT 2018, 'Add-on treatment with N-acetylcysteine for bipolar depression: a 24-week randomized double-blind parallel group placebo-controlled multicentre trial (NACOS-study protocol)', International Journal of Bipolar Disorders, vol. 6, no. 1, 11. https://doi.org/10.1186/s40345-018-0117-9

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title = "Add-on treatment with N-acetylcysteine for bipolar depression: a 24-week randomized double-blind parallel group placebo-controlled multicentre trial (NACOS-study protocol)",

abstract = "Background: Oxidative stress and inflammation may be involved in the development and progression of mood disorders, including bipolar disorder. Currently, there is a scarcity of useful treatment options for bipolar depressive episodes, especially compared with the efficacy of treatment for acute mania. N-Acetylcysteine (NAC) has been explored for psychiatric disorders for some time given its antioxidant and anti-inflammatory properties. The current trial aims at testing the clinical effects of adjunctive NAC treatment (compared to placebo) for bipolar depression. We will also explore the biological effects of NAC in this context. We hypothesize that adjunctive NAC treatment will reduce symptoms of depression, which will be reflected by changes in selected markers of oxidative stress. Methods and analysis: In the study, we will include adults diagnosed with bipolar disorder, in a currently depressive episode. Participants will undertake a 20-week, adjunctive, randomized, double-blinded, parallel group placebo-controlled trial comparing 3 grams of adjunctive NAC daily with placebo. The primary outcome is the mean change over time from baseline to end of study on the Montgomery–Asberg Depression Rating Scale (MADRS). Among the secondary outcomes are mean changes from baseline to end of study on the Bech-Rafaelsen Melancholia Scale (MES), the Young Mania Rating Scale (YMRS), the WHO-Five Well-being Index (WHO-5), the Global Assessment of Functioning scale (GAF-F), the Global Assessment of Symptoms scale (GAF-S) and the Clinical Global Impression-Severity scale (CGI-S). The potential effects on oxidative stress by NAC treatment will be measured through urine and blood samples. DNA will be examined for potential polymorphisms related to oxidative defences. Trial registration: Registered at The European Clinical Trials Database, ClinicalTrials.gov: NCT02294591 and The Danish Data Protection Agency: 2008-58-0035.",

keywords = "Acetylcysteine, Bipolar disorder, Blood, Depression, Genetics, Inflammation, Oxidative stress, Psychiatry, Treatment, Urine",

author = "Ellegaard, {Pernille Kempel} and Licht, {Rasmus Wentzer} and Poulsen, {Henrik Enghusen} and Nielsen, {Ren{\'e} Ernst} and Michael Berk and Dean, {Olivia May} and Mohammadreza Mohebbi and Nielsen, {Connie Thuroee}",

year = "2018",

doi = "10.1186/s40345-018-0117-9",

language = "English",

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journal = "International Journal of Bipolar Disorders",

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T2 - a 24-week randomized double-blind parallel group placebo-controlled multicentre trial (NACOS-study protocol)

AU - Ellegaard, Pernille Kempel

AU - Licht, Rasmus Wentzer

AU - Poulsen, Henrik Enghusen

AU - Nielsen, René Ernst

AU - Berk, Michael

AU - Dean, Olivia May

AU - Mohebbi, Mohammadreza

AU - Nielsen, Connie Thuroee

PY - 2018

Y1 - 2018

N2 - Background: Oxidative stress and inflammation may be involved in the development and progression of mood disorders, including bipolar disorder. Currently, there is a scarcity of useful treatment options for bipolar depressive episodes, especially compared with the efficacy of treatment for acute mania. N-Acetylcysteine (NAC) has been explored for psychiatric disorders for some time given its antioxidant and anti-inflammatory properties. The current trial aims at testing the clinical effects of adjunctive NAC treatment (compared to placebo) for bipolar depression. We will also explore the biological effects of NAC in this context. We hypothesize that adjunctive NAC treatment will reduce symptoms of depression, which will be reflected by changes in selected markers of oxidative stress. Methods and analysis: In the study, we will include adults diagnosed with bipolar disorder, in a currently depressive episode. Participants will undertake a 20-week, adjunctive, randomized, double-blinded, parallel group placebo-controlled trial comparing 3 grams of adjunctive NAC daily with placebo. The primary outcome is the mean change over time from baseline to end of study on the Montgomery–Asberg Depression Rating Scale (MADRS). Among the secondary outcomes are mean changes from baseline to end of study on the Bech-Rafaelsen Melancholia Scale (MES), the Young Mania Rating Scale (YMRS), the WHO-Five Well-being Index (WHO-5), the Global Assessment of Functioning scale (GAF-F), the Global Assessment of Symptoms scale (GAF-S) and the Clinical Global Impression-Severity scale (CGI-S). The potential effects on oxidative stress by NAC treatment will be measured through urine and blood samples. DNA will be examined for potential polymorphisms related to oxidative defences. Trial registration: Registered at The European Clinical Trials Database, ClinicalTrials.gov: NCT02294591 and The Danish Data Protection Agency: 2008-58-0035.

AB - Background: Oxidative stress and inflammation may be involved in the development and progression of mood disorders, including bipolar disorder. Currently, there is a scarcity of useful treatment options for bipolar depressive episodes, especially compared with the efficacy of treatment for acute mania. N-Acetylcysteine (NAC) has been explored for psychiatric disorders for some time given its antioxidant and anti-inflammatory properties. The current trial aims at testing the clinical effects of adjunctive NAC treatment (compared to placebo) for bipolar depression. We will also explore the biological effects of NAC in this context. We hypothesize that adjunctive NAC treatment will reduce symptoms of depression, which will be reflected by changes in selected markers of oxidative stress. Methods and analysis: In the study, we will include adults diagnosed with bipolar disorder, in a currently depressive episode. Participants will undertake a 20-week, adjunctive, randomized, double-blinded, parallel group placebo-controlled trial comparing 3 grams of adjunctive NAC daily with placebo. The primary outcome is the mean change over time from baseline to end of study on the Montgomery–Asberg Depression Rating Scale (MADRS). Among the secondary outcomes are mean changes from baseline to end of study on the Bech-Rafaelsen Melancholia Scale (MES), the Young Mania Rating Scale (YMRS), the WHO-Five Well-being Index (WHO-5), the Global Assessment of Functioning scale (GAF-F), the Global Assessment of Symptoms scale (GAF-S) and the Clinical Global Impression-Severity scale (CGI-S). The potential effects on oxidative stress by NAC treatment will be measured through urine and blood samples. DNA will be examined for potential polymorphisms related to oxidative defences. Trial registration: Registered at The European Clinical Trials Database, ClinicalTrials.gov: NCT02294591 and The Danish Data Protection Agency: 2008-58-0035.

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KW - Blood

KW - Depression

KW - Genetics

KW - Inflammation

KW - Oxidative stress

KW - Psychiatry

KW - Treatment

KW - Urine

U2 - 10.1186/s40345-018-0117-9

DO - 10.1186/s40345-018-0117-9

M3 - Journal article

C2 - 29619634

AN - SCOPUS:85056246495

SN - 2194-7511

VL - 6

JO - International Journal of Bipolar Disorders

JF - International Journal of Bipolar Disorders

IS - 1

M1 - 11

ER -

Add-on treatment with N-acetylcysteine for bipolar depression: a 24-week randomized double-blind parallel group placebo-controlled multicentre trial (NACOS-study protocol)

Abstract

Keywords

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