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In this paper, the case study of ketamine as a new treatment for severe depression is used to outline the challenges of repurposing established medicines and we suggest potential solutions. The antidepressant effects of generic racemic ketamine were identified over 20 years ago, but there were insufficient incentives for commercial entities to pursue its registration, or support for non-commercial entities to fill this gap. As a result, the evaluation of generic ketamine was delayed, piecemeal, uncoordinated, and insufficient to gain approval. Meanwhile, substantial commercial investment enabled the widespread registration of a patented, intranasal s-enantiomeric ketamine formulation (Spravato®) for depression. However, Spravato is priced at $600–$900/dose compared to ~$5/dose for generic ketamine, and the ~AUD$100 million annual government investment requested in Australia (to cover drug costs alone) has been rejected twice, leaving this treatment largely inaccessible for Australian patients 2 years after Therapeutic Goods Administration approval. Moreover, emerging evidence indicates that generic racemic ketamine is at least as effective as Spravato, but no comparative trials were required for regulatory approval and have not been conducted. Without action, this story will repeat regularly in the next decade with a new wave of psychedelic-assisted psychotherapy treatments, for which the original off-patent molecules could be available at low-cost and reduce the overall cost of treatment. Several systemic reforms are required to ensure that affordable, effective options become accessible; these include commercial incentives, public and public–private funding schemes, reduced regulatory barriers and more coordinated international public funding schemes to support translational research. [ABSTRACT FROM AUTHOR]

Background: Social isolation and loneliness can occur in all age groups, and they are linked to increased mortality and poorer health outcomes. There is a growing body of research indicating inconsistent findings on the effectiveness of interventions aiming to alleviate social isolation and loneliness. Hence the need to facilitate the discoverability of research on these interventions. Objectives: To map available evidence on the effects of in‐person interventions aimed at mitigating social isolation and/or loneliness across all age groups and settings. Search Methods: The following databases were searched from inception up to 17 February 2022 with no language restrictions: Ovid MEDLINE, Embase, EBM Reviews—Cochrane Central Register of Controlled Trials, APA PsycInfo via Ovid, CINAHL via EBSCO, EBSCO (all databases except CINAHL), Global Index Medicus, ProQuest (all databases), ProQuest ERIC, Web of Science, Korean Citation Index, Russian Science Citation Index, and SciELO Citation Index via Clarivate, and Elsevier Scopus. Selection Criteria: Titles, abstracts, and full texts of potentially eligible articles identified were screened independently by two reviewers for inclusion following the outlined eligibility criteria. Data Collection and Analysis: We developed and pilot tested a data extraction code set in Eppi‐Reviewer. Data was individually extracted and coded. We used the AMSTAR2 tool to assess the quality of reviews. However, the quality of the primary studies was not assessed. Main Results: A total of 513 articles (421 primary studies and 92 systematic reviews) were included in this evidence and gap map which assessed the effectiveness of in‐person interventions to reduce social isolation and loneliness. Most (68%) of the reviews were classified as critically low quality, while less than 5% were classified as high or moderate quality. Most reviews looked at interpersonal delivery and community‐based delivery interventions, especially interventions for changing cognition led by a health professional and group activities, respectively. Loneliness, wellbeing, and depression/anxiety were the most assessed outcomes. Most research was conducted in high‐income countries, concentrated in the United States, United Kingdom, and Australia, with none from low‐income countries. Major gaps were identified in societal level and community‐based delivery interventions that address policies and community structures, respectively. Less than 5% of included reviews assessed process indicators or implementation outcomes. Similar patterns of evidence and gaps were found in primary studies. All age groups were represented but more reviews and primary studies focused on older adults (≥60 years, 63%) compared to young people (≤24 years, 34%). Two thirds described how at‐risk populations were identified and even fewer assessed differences in effect across equity factors for populations experiencing inequities. Authors' Conclusions: There is growing evidence that social isolation and loneliness are public health concerns. This evidence and gap map shows the available evidence, at the time of the search, on the effectiveness of in‐person interventions at reducing social isolation and loneliness across all ages and settings. Despite a large body of research, with much of it published in more recent years, it is unevenly distributed geographically and across types of interventions and outcomes. Most of the systematic reviews are of critically low quality, indicating the need for high quality reviews. This map can guide funders and researchers to consider the areas in which the evidence is lacking and to address these gaps as future research priorities. [ABSTRACT FROM AUTHOR]

Background: Music therapy interventions with informal carers of individuals with life-threatening illness at pre- and post-bereavement is an increasingly important clinical area. This systematic review is the first to synthesise and critically evaluate the international evidence associated with music therapy with adult informal carers pre- and post-bereavement. Specifically, the objectives were: i) to describe the characteristics and effectiveness of music therapy interventions which aim to improve health-related outcomes for adult informal carers of adults with life-threatening illness (pre- and post-bereavement), and ii) to describe the experience of music therapy for adult informal carers of adults with life-threatening illness (pre- and post-bereavement). Methods: Eligibility: adult informal carers of adults at end of life or bereaved; music therapy interventions for improving health-related outcomes; qualitative; mixed-method; and quantitative studies including comparators of any other intervention; published in English from 1998 onwards. Six databases were searched up to July 2022. A JBI mixed-methods systematic review approach was followed throughout, including quality appraisal, data extraction and a convergent segregated approach to synthesis and integration. Results: A total of 34 studies were included, published between 2003 and 2022. Most were conducted in North America (n = 13), Australia (n = 10), or Europe (n = 8). No studies were conducted in low- and middle-income countries or in the UK. The majority were qualitative (n = 17), followed by quasi-experimental (n = 8), mixed-methods (n = 7) and two RCTs. The majority focused on carers of individuals with dementia (n = 21) or advanced cancer (n = 7). Seventeen studies were purely quantitative or included a quantitative component. During meta-synthesis, findings were aligned to core outcomes for evaluating bereavement interventions in palliative care and previously identified risk factors for complicated grief. Commonly targeted outcomes in quantitative studies included quality of life and mental wellbeing, showing equivocal effectiveness of music therapy with significant and non-significant results. Twenty-two studies either purely qualitative or with a qualitative component underwent meta synthesis and suggested a diverse range of improved pre- and post-bereavement outcomes for informal carers across all core outcomes, and across all risk and protective factors, including psychological, spiritual, emotional, and social outcomes. Conclusions: Qualitative studies provide moderate to strong evidence for improved health-related outcomes for adult informal carers of adults with life-threatening illness pre-bereavement. Limited studies including those bereaved negates conclusions for the bereavement phase. Comparisons and explanations for effectiveness across quantitative and qualitative studies are equivocal, with a high risk of bias and small samples in the limited number of quantitative studies, demonstrating a need for high-quality RCTs. Systematic review pre-registration: PROSPERO [CRD42021244859]. [ABSTRACT FROM AUTHOR]

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