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This paper synthesises critique from Māori patients with Bipolar Disorder (BD) and their whānau to identify barriers and propose changes to improve the structure and function of the New Zealand mental health system. A qualitative Kaupapa Māori Research methodology was used. Twenty-four semi-structured interviews were completed with Māori patients with BD and members of their whānau. Structural, descriptive and pattern coding was completed using an adapted cultural competence framework to organise and analyse the data. Three key themes identified the impact of structural features of the New Zealand mental health system on health equity for Māori with BD. Themes involved the accessibility, delivery and scope of the current health system, and described how structural features influenced the quality, utility and availability of BD services for Māori patients and whānau. Structural barriers in the existing design, and potential changes to improve the accessibility, delivery and scope of BD services for Māori, were proposed including a redesign of operational, environmental, staffing, and navigation points (information, transition, fatigue) to better meet the needs of Māori with BD. A commitment to equity when implementing structural change is needed, including ongoing evaluation and refinement. This paper provides specific recommendations that should be considered in health service redesign to ensure the New Zealand mental health system meets the needs of Māori patients with BD and their whānau. [ABSTRACT FROM AUTHOR]

Accessible summary: What is known on the subject?: Medication does not always resolve a serious mood episode, and there is evidence that it needs to be combined with an evidence‐based psychotherapy to promote symptomatic and functional recovery.There is little known about what people with serious mood disorders want from mental health services to manage their mood. What the paper adds to existing knowledge?: Participants in this study wanted a framework other than the medical model for understanding and managing their mood.Their motivation to commence psychotherapy was based on a sense of having hit rock bottom and a need for understanding what was happening in order to better manage their mood. Introduction: There is little known about the motivations for people to participate in psychotherapy for depression. Aim: To explore why people, with a diagnosis of major depressive episode, chose to take part in a psychotherapy study and what they expected it to involve. Method: This was a qualitative study of participants' motivations and understandings of psychotherapy for depression. Data were collected using semi‐structured interviews and analysed using thematic analysis. Findings: Eight females and eight males with an age range from 21 years to 55 years were recruited. Three themes were identified that described why participants chose to participate in psychotherapy: medication was not enough, a turning point and making sense of experience. The participants chose to participate in psychotherapy after finding that medication was insufficient and this combined with a sense of crisis motivated them to engage in psychotherapy in order to learn to manage their mood differently. Discussion: The participants recognized that they wanted a framework other than a medical model with its reliance on medication, in order to make sense of their experiences and develop new self‐management strategies. Implications for Practice: Our study suggests that some people experiencing a serious mood disorder access psychotherapy after "hitting rock bottom" and finding insufficient help from medications. Mental health nurses need to be aware people do not always want a medical model approach to treatment of serious mood disorders and they need to provide the opportunity of engaging in a psychotherapeutic framework in order to better understand and manage their mood. [ABSTRACT FROM AUTHOR]

Objective: Research designed to increase knowledge about Māori with bipolar disorder is required to understand how health services support wellbeing and respond to identified levels of community need. This paper synthesises the expert critique of Māori patients with bipolar disorder and their whānau regarding the nuances of cultural competence and safety in clinical encounters with the health system. Methods: A qualitative Kaupapa Māori Research methodology was used. A total of 24 semi-structured interviews were completed with Māori patients with bipolar disorder and members of their whānau. Structural, descriptive and pattern coding was completed using an adapted cultural competence framework to organise and analyse the data. Results: Three themes were evident from participants' critique of clinical components of the health system. Theme 1 established that the efficacy of clinical care for bipolar disorder was dependent on Māori patients and whānau having clear pathways through care, and being able to access timely, consistent care from clinically and culturally competent staff. Theme 2 identified the influence of clinical culture in bipolar disorder services, embedded into care settings, expressed by staff, affecting the safety of clinical care for Māori. Theme 3 focused on the need for bipolar disorder services to prioritise clinical work with whānau, equip staff with skills to facilitate engagement and tailor care with resources to enhance whānau as well as patient wellbeing. Conclusion: The standard of clinical care for Māori with bipolar disorder in New Zealand does not align with practice guidelines, Māori models of health or clinical frameworks designed to inform treatment and address systemic barriers to equity. Research also needs to explore the role of structural and organisational features of the health system on Māori patient and whānau experiences of care. [ABSTRACT FROM AUTHOR]

Background: Data on trends in the epidemiological burden of bipolar disorder are scarce. Aims: To provide an overview of trends in bipolar disorder burden from 1990 to 2019. Method: Revisiting the Global Burden of Disease Study 2019, we analysed the number of cases, calculated the age-standardised rate (per 100 000 population) and estimated annual percentage change (EAPC) of incidence, prevalence and years lived with disability (YLDs) for bipolar disorder from 1990 to 2019. The independent effects of age, period and cohort were estimated by the age–period–cohort modelling. Results: Globally, the bipolar disorder-related prevalent cases, incident cases and number of YLDs all increased from 1990 to 2019. Regionally, the World Health Organization Region of the Americas accounted for the highest estimated YLD number and rate, with the highest age-standardised prevalence rate in 1990 and 2019 and highest EAPC of prevalence. By sociodemographic index (SDI) quintiles, all five SDI regions saw an increase in estimated incident cases. Nationally, New Zealand reported the highest age-standardised rate of incidence, prevalence and YLDs in 1990 and 2019. The most prominent age effect on incidence rate was in those aged 15–19 years. Decreased effects of period on incidence, prevalence and YLD rates was observed overall and in females, not in males. The incidence, prevalence and YLD rates showed an unfavourable trend in the younger cohorts born after 1990, with males reporting a higher cohort risk than females. Conclusions: From 1990 to 2019, the overall trend of bipolar disorder burden presents regional and national variations and differs by age, sex, period and cohort. [ABSTRACT FROM AUTHOR]

Aims: There is very little empirical evidence about the relationship between severe mental illness and the physical health of Indigenous peoples. This paper aims to compare the physical health of Māori and non-Māori with a diagnosis of bipolar disorder in contact with NZ mental health services. Methods: A cohort of Māori and non-Māori with a current bipolar disorder diagnosis at 1 January 2010 were identified from routine mental health services data and followed up for non-psychiatric hospital admissions and deaths over the subsequent 5 years. Results: Māori with bipolar disorder had a higher level of morbidity and a higher risk of death from natural causes compared to non-Māori with the same diagnosis, indicating higher levels of physical health need. The rate of medical and surgical hospitalisation was not higher among Māori compared to non-Māori (as might be expected given increased health needs) which suggests under-treatment of physical health conditions in this group may be a factor in the observed higher risk of mortality from natural causes for Māori. Conclusion: This study provides the first indication that systemic factors which cause health inequities between Māori and non-Māori are compounded for Māori living with severe mental illness. Further exploration of other diagnostic groups and subgroups is needed to understand the best approach to reducing these inequalities. [ABSTRACT FROM AUTHOR]

Objective: To detail the methodology of an online study designed to test the utility of a bipolar self-test screening measure. Method: We describe the current technical success of an online methodology in recruiting a large sample with minimal cost. Results: Over some six months, more than 120 000 people accessed the Black Dog Institute Bipolar Self-Test, with screening criteria allowing a cohort to be recruited. Conclusion: This paper details the overall study strategy that will be reported on after a large finite sample has been derived. [ABSTRACT FROM AUTHOR]

Objective: We carried out a bibliometric study on the scientific papers related to secondgeneration antipsychotic drugs (SGAs) in Malaysia. Methods: With the SCOPUS database, we selected those documents made in Malaysia whose title included descriptors related to SGAs. We applied bibliometric indicators of production and dispersion, as Price's law and Bradford's law, respectively. We also calculated the participation index of the different countries. The bibliometric data were also been correlated with some social and health data from Malaysia (total per capita expenditure on health and gross domestic expenditure on R&D). Results: We found 105 original documents published between 2004 and 2016. Our results fulfilled Price's law, with scientific production on SGAs showing exponential growth (r = 0.401, vs. r = 0.260 after linear adjustment). The drugs most studied are olanzapine (9 documents), clozapine (7), and risperidone (7). Division into Bradford zones yields a nucleus occupied by the Medical Journal of Malaysia, Singapore Medical Journal, Australian and New Zealand Journal of Psychiatry, and Pharmacogenomics. Totally, 63 different journals were used, but only one in the top four journals had an impact factor being greater than 3. Conclusion: The publications on SGAs in Malaysia have undergone exponential growth, without evidence a saturation point. [ABSTRACT FROM AUTHOR]

Introduction. Quality of health care contributes to poor physical health outcomes for people with mental health and substance use conditions (MHSUC). AIM. This study investigated experiences of people with MHSUC who sought help for a physical health condition in primary healthcare services, examining quality of care attributes. Methods. An online survey of adults currently or recently accessing services for MHSUC was fielded in 2022. Respondents were recruited nationally through mental health, addiction and lived experience networks and social media. The attributes of service quality assessed were relationships (respect and being listened to), discrimination due to MHSUC, and diagnostic overshadowing (MHSUC diagnosis distracted from physical health care). Results. Respondents who had used primary care services were included (n = 335). The majority of respondents reported both being treated with respect (81%) and being listened to (79%) always or most of the time. A minority of respondents reported diagnostic overshadowing (20%) or discrimination due to MHSUC (10%). People with four or more diagnoses or a diagnosis of bipolar disorder or schizophrenia had significantly worse experiences across all quality measures. Those with a diagnosis of substance use disorders had worse experiences for diagnostic overshadowing. Māori had worse experiences for respect and diagnostic overshadowing. Conclusions. Although many respondents reported good experiences in primary care, this was not the case for everyone. Quality of care was affected by type and number of diagnoses and the person's ethnicity. Interventions to reduce stigma and diagnostic overshadowing for people with MHSUC are needed in primary care services in New Zealand. [ABSTRACT FROM AUTHOR]

Objectives: To retrospectively analyse patients receiving maintenance Electroconvulsive therapy (ECT), patterns of ECT treatment administration and impact on hospitalisation before and during treatment, in a single New Zealand District Health Board catchment. We also asked other District Health Boards in New Zealand for annual data on their use of maintenance ECT. Methods: Regional analysis: retrospective analysis of patient-level data over 9 years. National analysis: survey of maintenance ECT/year. Results: Regionally, 14 patients received maintenance ECT over 9 years. Patients were 50% male, with mean age 59 years, and principal diagnoses included schizophrenia, bipolar disorder and major depressive disorder. The time between ECT treatments tended to be shorter for patients with schizophrenia compared with those with mood disorders. Duration of time in hospital during maintenance ECT, compared with pre-ECT, was reduced by 52% for all patients, with greater reductions for patients with mood disorders compared with those with schizophrenia. Nationally, 19.7% of all ECT treatments in New Zealand (range 4–57%) were for maintenance treatment. Discussion: Regional and national use patterns of maintenance ECT in New Zealand resemble those reported internationally. The RANZCP section of neurostimulation is planning ECT standards which would assist with ensuring coherence and quality of High-dose contrast-enhanced computed tomography/modified electroconvulsive therapy practice in New Zealand. [ABSTRACT FROM AUTHOR]

Background: Individuals with mood disorders frequently experience cognitive impairment, which impacts on the long-term trajectory of the disorders, including being associated with persisting difficulties in occupational and psychosocial functioning, residual mood symptoms, and relapse. Current first-line treatments for mood disorders do little to improve cognitive function. Targeting cognition in clinical research is thus considered a priority. This protocol outlines a prospectively-registered randomised controlled trial (RCT) which examines the impact of adding group-based Cognitive Remediation (CR) to Interpersonal and Social Rhythm Therapy (IPSRT-CR) for individuals with mood disorders. Methods: This is a pragmatic, two-arm, single-blinded RCT comparing IPSRT-CR with IPSRT alone for adults (n = 100) with mood disorders (Major Depressive Disorder or Bipolar Disorder) with subjective cognitive difficulties, on discharge from Specialist Mental Health Services in Christchurch, New Zealand. Both treatment arms will receive a 12-month course of individual IPSRT (full dose = 24 sessions). At 6 months, randomisation to receive, or not, an 8-week group-based CR programme (Action-based Cognitive Remediation – New Zealand) will occur. The primary outcome will be change in Global Cognition between 6 and 12 months (treatment-end) in IPSRT-CR versus IPSRT alone. Secondary outcomes will be change in cognitive, functional, and mood outcomes at 6, 12, 18, and 24 months from baseline and exploratory outcomes include change in quality of life, medication adherence, rumination, and inflammatory markers between treatment arms. Outcome analyses will use an intention-to-treat approach. Sub-group analyses will assess the impact of baseline features on CR treatment response. Participants' experiences of their mood disorder, including treatment, will be examined using qualitative analysis. Discussion: This will be the first RCT to combine group-based CR with an evidence-based psychotherapy for adults with mood disorders. The trial may provide valuable information regarding how we can help promote long-term recovery from mood disorders. Many issues have been considered in developing this protocol, including: recruitment of the spectrum of mood disorders, screening for cognitive impairment, dose and timing of the CR intervention, choice of comparator treatment, and choice of outcome measures. Trial registration: Australian and New Zealand Clinical Trials Registry, ACTRN12619001080112. Registered on 6 August 2019. [ABSTRACT FROM AUTHOR]

Objectives: To provide a succinct, clinically useful summary of the management of bipolar disorder, based on the 2020 Royal Australian and New Zealand College of Psychiatrists clinical practice guidelines for mood disorders (MDcpg2020). Methods: To develop the MDcpg2020, the mood disorders committee conducted an extensive review of the available literature to develop evidence‐based recommendations (EBR) based on National Health and Medical Research Council (NHMRC) guidelines. In the MDcpg2020, these recommendations sit alongside consensus‐based recommendations (CBR) that were derived from extensive deliberations of the mood disorders committee, drawing on their expertise and clinical experience. This guideline summary is an abridged version that focuses on bipolar disorder. In collaboration with international experts in the field, it synthesises the key recommendations made in relation to the diagnosis and management of bipolar disorder. Results: The bipolar disorder summary provides a systematic approach to diagnosis, and a logical clinical framework for management. It addresses the acute phases of bipolar disorder (mania, depression and mixed states) and its longer‐term management (maintenance and prophylaxis). For each phase it begins with Actions, which include important strategies that should be implemented from the outset wherever possible. These include for example, lifestyle changes, psychoeducation and psychological interventions. In each phase, the summary advocates the use of Choice medications for pharmacotherapy, which are then used in combinations along with additional Alternatives to manage acute symptoms or maintain mood stability and provide prophylaxis. The summary also recommends the use of electroconvulsive therapy (ECT) for each of the acute phases but not for maintenance therapy. Finally, it briefly considers bipolar disorder in children and its overlap in adults with borderline personality disorder. Conclusions: The bipolar disorder summary provides up to date guidance regarding the management of bipolar disorder, as set out in the MDcpg2020. The recommendations are informed by evidence and clinical expertise and experience. The summary is intended for use by psychiatrists, psychologists and primary care physicians but will be of interest to anyone involved in the management of patients with bipolar disorder. [ABSTRACT FROM AUTHOR]

Background: People with a family history of major depressive disorder (MDD) or bipolar disorder (BD) report specific psychoeducational needs that are unmet by existing online interventions. This trial aimed to test whether an interactive website for people at familial risk for depression (intervention) would improve intention to adopt, or actual adoption of, depression prevention strategies (primary outcome) and a range of secondary outcome measures. Methods: In this cluster randomised trial, primary care practises were randomised to either provide the link to the intervention or the control website. Primary health care attendees were invited by letter to opt into this study if they had at least one first-degree relative with MDD or BD and were asked to complete online questionnaires at baseline and 2-week follow-up. Results: Twenty general practices were a randomized, and 202 eligible patients completed both questionnaires. Thirty-nine (19.3%) of participants were male and 163 (80.7%) female. At follow-up, compared to controls, the intervention group: (i) were more likely to intend to undergo, or to have actually undergone, psychological therapies (OR = 5.83, 95% CI: 1.58–21.47, p =.008); (ii) had better knowledge of depression risk factors and prevention strategies (mean difference = 0.47, 95% CI: 0.05–0.88, p =.029); and (iii) were more likely to accurately estimate their lifetime risk of developing BD (mean difference = 11.2, 95% CI: -16.52– -5.73, p <.001). There were no statistically significant between-group differences in change from baseline to follow up for any of the remaining outcome measures (Patient Health Questionnaire, Perceived Devaluation-Discrimination Questionnaire and Perceived Risk of Developing MDD). Conclusion: The opt-in nature of the study may have led to participation bias, e.g. underrepresentation of males, and hence may limit generalisability to the broader population at familial risk for depression. This is the first website internationally focusing specifically on informational needs of those at familial risk of depression. Our interactive website can play an important role in improving the outcomes of individuals at familial risk for depression. Testing the intervention in other settings (e.g. psychology, psychiatry, genetic counselling) appears warranted. Trial registration: The study was prospectively registered with the Australian and New Zealand Clinical Trials Group (Registration no: ACTRN12613000402741). [ABSTRACT FROM AUTHOR]

INTRODUCTION: In New Zealand, as in other OECD countries, there is a high and growing prevalence of mental health problems, particularly anxiety and depression. These conditions are associated with a range of physical illnesses, and as a result this population have high and often complex needs for healthcare services, particularly through primary care. AIM: To use data from the New Zealand Health Survey (NZHS) to examine the associations between internalising disorders (including anxiety, depression and bipolar disorder) and measures related to the utilisation of primary healthcare services. METHODS: The study was based on responses from 13,719 adults who took part in the 2015-16 NZHS. Logistic regression analyses adjusted for sociodemographic variables were undertaken to examine the effect of having an internalising disorder on each measure related to primary healthcare utilisation. The strength of associations was indicated by odds ratios (ORs). RESULTS: Adults with an internalising disorder were more likely to utilise primary health services (OR = 1.43-2.56, P < 0.001) compared to adults without an internalising disorder. However, they were more likely to have unmet needs due to cost or transport (OR = 2.45-3.38, P < 0.001), unfilled prescriptions due to cost (OR = 3.03, P < 0.001) and less likely to report positive experiences with general practitioners (OR = 0.67-0.79, P < 0.01). DISCUSSION: Adults with internalising disorders require a higher level of support from primary healthcare, yet experience more barriers to accessing these services, and report less positive experiences with general practitioners. The NZHS may be a useful source of routinely collected data for understanding, monitoring and improving primary health service utilisation among people with internalising disorders. [ABSTRACT FROM AUTHOR]

Background: ‘Paediatric bipolar disorder’ (PBD) is a controversial diagnosis where often prepubertal children as well as adolescents, who may have a range of psychiatric disorders or symptoms, are diagnosed with a severe mental illness requiring lifelong medication. Clinically, it has often been applied in the United States but rarely in most other countries. A meta‐analysis (Van Meter et al., Journal of Clinical Psychiatry, , 72, 1250) claimed that the prevalence of PBD was similar to adults at 1.8% with no difference between the United States and other countries. This conclusion has been highly cited. Methods: The heterogeneous nature of the original 12 epidemiological surveys warrants a qualitative analysis, rather than statistical meta‐analysis as performed by Van Meter et al. (Journal of Clinical Psychiatry, 2011, 72, 1250). Thus, the meta‐analysis and each of the 12 studies (six from the United States; six from other countries) were reexamined. Results: Most of the 12 surveys predated the emergence of the PBD hypothesis. The 12 surveys were mainly of adolescents and at times young adults with few prepubertal children. Prevalence rates in the 12 studies suggest a lower rate of bipolar disorder, especially in non‐US samples. For example, the Van Meter et al. (Journal of Clinical Psychiatry, 2011, 72, 1250) meta‐analysis chose a rate of 2.8% by summation of adolescent and parent responses in a Dutch survey, however the rate fell to 0% if requiring concordance of adolescent and parent responses. Indeed, it could be argued that four of the non‐US studies show 0% rates of PBD. Conclusions: Rates of PBD were generally substantially lower than 1.8%, particularly in non‐US surveys, and if both parent and adolescent reports were required to meet the diagnostic threshold they fell to close to zero. The reanalysis suggests that bipolar disorder is rare before the expected age of onset in later adolescence. [ABSTRACT FROM AUTHOR]

Aims: The aim of the study presented in this article was to consider how New Zealand Chinese with bipolar disorder manage their condition, regain and maintain wellness through the use of self-management techniques. Methods: Nine New Zealand Chinese with bipolar disorder type I or II who had reasonable performance in role functioning were interviewed. Data analysis was guided by the inductive approach. Findings: In contrast to Western psychosocial interventions, which emphasize the individual's independence, self-advocacy and self-identity, New Zealand Chinese are more likely to value themselves through relationships with others. Most participants emphasized the importance of harmony with self and others, and adopted passive and nature-oriented attitudes encouraged by Taoism to deal with life stress. Strategies of 'taking it easy' and 'looking at problems in others' shoes' were frequently used when dealing with interpersonal conflicts. Conclusions: The concepts of health and life as part of traditional Chinese culture were found to be the fundamental elements influencing the participants' coping patterns. There is a strong need for facilitating the connection between health professionals and clients. This study indicates that to do this, health professionals must be aware of the importance of cultural sensitivity when delivering health care in a multicultural environment. [ABSTRACT FROM AUTHOR]

Background: The paediatric bipolar disorder (PBD) hypothesis arose in the USA and proposes childhood onset and high rates of prevalence. Method: Child and adolescent psychiatrists in Australia and New Zealand were surveyed about the PBD hypothesis. Results: Sixty percent responded ( N = 199) and most (53%) reported never having diagnosed pre-pubertal PBD and a further 29% estimated seeing ‘1 or 2’ cases. Most (83%) rated pre-pubertal PBD as ‘very rare’, ‘rare’ or ‘not diagnosable’. Opinion varied as to whether PBD was over-diagnosed (25%), appropriately diagnosed (42%), or under-diagnosed (28%) in Australia and New Zealand, 5% were unsure. In contrast there was a consensus of views that PBD was over-diagnosed in the USA (90%), whilst less felt it appropriately diagnosed (3%), or under-diagnosed (1%) and 6% were unsure. Conclusions: The majority view was consistent with classical descriptions of bipolar disorder. [ABSTRACT FROM AUTHOR]

Background: Many patients with bipolar II disorder (BPII) prefer to be more informed and involved in their treatment decision-making than they currently are. Limited knowledge and involvement in one's treatment is also likely to compromise optimal BPII management. This Phase II RCT aimed to evaluate the acceptability, feasibility, and safety of a world-first patient decision-aid website (e-DA) to improve treatment decision-making regarding options for relapse prevention in BPII. The e-DA's potential efficacy in terms of improving quality of the decision-making process and quality of the decision made was also explored. Methods: The e-DA was based on International Patient Decision-Aid Standards and developed via an iterative co-design process. Adults with BPII diagnosis (n = 352) were recruited through a specialist outpatient clinical service and the social media of leading mental health organisations. Participants were randomised (1:1) to receive standard information with/without the e-DA (Intervention versus Control). At baseline (T0), post-treatment decision (T1) and at 3 months' post-decision follow-up (T2), participants completed a series of validated and purpose-designed questionnaires. Self-report and analytics data assessed the acceptability (e.g., perceived ease-of-use, usefulness; completed by Intervention participants only), safety (i.e., self-reported bipolar and/or anxiety symptoms), and feasibility of using the e-DA (% accessed). For all participants, questionnaires assessed constructs related to quality of the decision-making process (e.g., decisional conflict) and quality of the decision made (e.g., knowledge of treatment options and outcomes). Results: Intervention participants endorsed the e-DA as acceptable and feasible to use (82.1–94.6% item agreement); most self-reported using the e-DA either selectively (51.8%; relevant sections only) or thoroughly (34%). Exploratory analyses indicated the e-DA's potential efficacy to improve decision-making quality; most between-group standardised mean differences (SMD) were small-to-moderate. The largest potential effects were detected for objective treatment knowledge (− 0.69, 95% CIs − 1.04, − 0.33 at T1; and − 0.57, 95% CIs − 0.99,-0.14 at T2), decisional regret at T2 (0.42, 95% CIs 0.01, 0.84), preparation for decision-making at T1 (− 0.44, 95% CIs − 0.81, − 0.07), and the Decisional Conflict Scale Uncertainty subscale (0.42, 95% CIs 0.08, 0.08) and Total (0.36, 95% CIs 0.30, 0.69) scores, with all SMDs favouring the Intervention over the Control conditions. Regarding safety, e-DA use was not associated with worse bipolar symptoms or anxiety. Conclusion: The e-DA appears to be acceptable, feasible, safe and potentially efficacious at improving patients' decision-making about BPII treatment. Findings also support the future adoption of the e-DA into patient care for BPII to foster treatment decisions based on the best available evidence and patient preferences. Trial registration: Australian New Zealand Clinical Trials Registry ACTRN12617000840381 (prospectively registered 07/06/2017). [ABSTRACT FROM AUTHOR]

Background: First-episode psychosis (FEP) may lead to a progressive, potentially disabling and lifelong chronic illness; however, evidence suggests that the illness course can be improved if appropriate treatments are given at the early stages. Nonetheless, the efficacy of antipsychotic medications is suboptimal, particularly for negative and cognitive symptoms, and more efficacious and benign treatments are needed. Previous studies have shown that the antioxidant amino acid N-acetylcysteine (NAC) reduces negative symptoms and improves functioning in chronic schizophrenia and bipolar disorder. Research is scarce as to whether NAC is beneficial earlier in the course of illness. The primary aim of this study is to determine the efficacy of treatment with adjunctive NAC (2 g/day for 26 weeks) compared with placebo to improve psychiatric symptoms in young people experiencing FEP. Secondary aims are to explore the neurobiological mechanisms underpinning NAC and how they relate to various clinical and functional outcomes at 26- and 52-week follow-ups.Methods/design: ENACT is a 26-week, randomised controlled trial of adjunctive NAC versus placebo, with a 26-week non-treatment follow-up period, for FEP. We will be recruiting 162 young people aged 15-25 years who have recently presented to, and are being treated at, the Early Psychosis Prevention and Intervention Centre, Melbourne, Australia. The primary outcome is the Total Score on the Positive and Negative Syndrome Scale which will be administered at baseline, and weeks 4, 8, 12, 26 (primary endpoint), and 52 (end of study). Secondary outcomes include: symptomatology, functioning, quality of life, neurocognition, blood-derived measures of: inflammation, oxidative and nitrosative stress, and magnetic resonance spectroscopy measures of glutathione concentration.Discussion: Targeted drug development for FEP to date has generally not involved the exploration of neuroprotective agents. This study has the potential to offer a new, safe, and efficacious treatment for people with FEP, leading to better treatment outcomes. Additionally, the neuroprotective dimension of this study may lead to a better long-term prognosis for people with FEP. It has the potential to uncover a novel treatment that targets the neurobiological mechanisms of FEP and, if successful, will be a major advance for psychiatry.Trial Registration: Australian New Zealand Clinical Trials Registry, ID: ACTRN12618000413224. Registered on 21 March 2018. [ABSTRACT FROM AUTHOR]