dc.contributor.author |
Plank, Julia R |
|
dc.contributor.author |
Glover, Stephanie C |
|
dc.contributor.author |
Moloney, Ben D |
|
dc.contributor.author |
Hoeh, Nicholas R |
|
dc.contributor.author |
Sundram, Frederick |
|
dc.contributor.author |
Sumner, Rachael L |
|
dc.contributor.author |
Muthukumaraswamy, Suresh |
|
dc.contributor.author |
Lin, Joanne C |
|
dc.coverage.spatial |
England |
|
dc.date.accessioned |
2023-01-17T01:34:43Z |
|
dc.date.available |
2023-01-17T01:34:43Z |
|
dc.date.issued |
2022-09 |
|
dc.identifier.citation |
(2022). Trials, 23(1), 822-. |
|
dc.identifier.issn |
1745-6215 |
|
dc.identifier.uri |
https://hdl.handle.net/2292/62392 |
|
dc.description.abstract |
<h4>Background</h4>Major depressive disorder (MDD) is a leading cause of disability worldwide. The current treatments are ineffective in approximately one-third of patients, resulting in a large economic burden and reduced quality of life for a significant proportion of the global population. There is considerable evidence that increased inflammation may distinguish a sub-type of MDD, and there are no validated diagnostic tools or treatments for neuroinflammation in MDD patients. The current study aims to explore the potential role of low-dose naltrexone (LDN), a drug with purported anti-inflammatory properties in the central nervous system, as an adjunctive treatment in patients with MDD.<h4>Methods/design</h4>This double-blind placebo-controlled hybrid parallel arm study enables the exploration of peripheral and central inflammatory markers with LDN as an approach to investigate inflammation as a pathophysiological contributor to MDD. Eligible participants with MDD (n = 48) will be stratified into the high and low inflammatory groups according to the levels of high-sensitivity C-reactive protein (hs-CRP) and then randomized to receive LDN or placebo for an initial 12 weeks, followed by a further 12 weeks during which all participants will receive LDN. The primary outcome measure will be the Montgomery-Åsberg Depression Rating Scale (MADRS) administered at baseline, 2 weeks, 4 weeks, 8 weeks, 12 weeks, 14 weeks, 16 weeks, 20 weeks, and 24 weeks, to assess the effectiveness of the anti-depressant response. The secondary outcomes include the use of MRI techniques including quantitative magnetization transfer (qMT), echo-planar spectroscopic imaging (EPSI), and diffusion-weighted imaging (DWI) to help to elucidate the neurobiological mechanism of LDN, and the inflammatory mechanisms in action in MDD. Electroencephalography, blood samples, cognitive tasks, and additional questionnaires will also be used to determine if there is a specific profile of symptoms in individuals with inflammatory MDD. Healthy participants (n = 24) will be recruited for baseline outcome measures only, to enable comparison with patients with MDD.<h4>Discussion</h4>This trial contributes to the literature on inflammation in MDD, including the understanding of the pathophysiology and efficacy of anti-inflammatory treatments. The investigation of inflammatory mechanisms in MDD is an important first step in the development of biomarkers to classify patient sub-groups, increase the accuracy of diagnosis, and tailor the approach to patients in clinical practice. This study may provide evidence of the benefit of LDN for the groups in whom conventional anti-depressants are ineffective and lead the way for translation into clinical practice.<h4>Trial registration</h4>Australian New Zealand Clinical Trials Registry ACTRN12622000881730 . Registered on 21 June 2022. |
|
dc.format.medium |
Electronic |
|
dc.language |
eng |
|
dc.publisher |
Springer Nature |
|
dc.relation.ispartofseries |
Trials |
|
dc.rights |
Items in ResearchSpace are protected by copyright, with all rights reserved, unless otherwise indicated. Previously published items are made available in accordance with the copyright policy of the publisher. |
|
dc.rights.uri |
https://researchspace.auckland.ac.nz/docs/uoa-docs/rights.htm |
|
dc.rights.uri |
https://creativecommons.org/licenses/by/4.0/ |
|
dc.subject |
Humans |
|
dc.subject |
Inflammation |
|
dc.subject |
Naltrexone |
|
dc.subject |
C-Reactive Protein |
|
dc.subject |
Anti-Inflammatory Agents |
|
dc.subject |
Treatment Outcome |
|
dc.subject |
Double-Blind Method |
|
dc.subject |
Depressive Disorder, Major |
|
dc.subject |
Quality of Life |
|
dc.subject |
Australia |
|
dc.subject |
Randomized Controlled Trials as Topic |
|
dc.subject |
Biomarkers |
|
dc.subject |
Serious Mental Illness |
|
dc.subject |
Mental Health |
|
dc.subject |
Biomedical Imaging |
|
dc.subject |
Depression |
|
dc.subject |
Clinical Trials and Supportive Activities |
|
dc.subject |
Clinical Research |
|
dc.subject |
Brain Disorders |
|
dc.subject |
Major Depressive Disorder |
|
dc.subject |
Neurosciences |
|
dc.subject |
6 Evaluation of treatments and therapeutic interventions |
|
dc.subject |
6.1 Pharmaceuticals |
|
dc.subject |
1102 Cardiorespiratory Medicine and Haematology |
|
dc.subject |
1103 Clinical Sciences |
|
dc.title |
A randomized, double-blind, placebo-controlled, hybrid parallel-arm study of low-dose naltrexone as an adjunctive anti-inflammatory treatment for major depressive disorder. |
|
dc.type |
Journal Article |
|
dc.identifier.doi |
10.1186/s13063-022-06738-3 |
|
pubs.issue |
1 |
|
pubs.begin-page |
822 |
|
pubs.volume |
23 |
|
dc.date.updated |
2022-12-02T17:53:50Z |
|
dc.rights.holder |
Copyright: The authors |
en |
dc.identifier.pmid |
36175917 (pubmed) |
|
pubs.author-url |
https://www.ncbi.nlm.nih.gov/pubmed/36175917 |
|
pubs.publication-status |
Published |
|
dc.rights.accessrights |
http://purl.org/eprint/accessRights/OpenAccess |
en |
pubs.subtype |
Clinical Trial Protocol |
|
pubs.subtype |
research-article |
|
pubs.subtype |
Journal Article |
|
pubs.elements-id |
922849 |
|
pubs.org-id |
Medical and Health Sciences |
|
pubs.org-id |
Pharmacy |
|
pubs.org-id |
School of Medicine |
|
pubs.org-id |
Psychological Medicine Dept |
|
dc.identifier.eissn |
1745-6215 |
|
dc.identifier.pii |
10.1186/s13063-022-06738-3 |
|
pubs.number |
822 |
|
pubs.record-created-at-source-date |
2022-12-03 |
|
pubs.online-publication-date |
2022-09-30 |
|