Safe and effective use of lithium

Lithium has proven efficacy in the treatment of bipolar disorder, both for acute mania and long-term mood stabilisation and prophylaxis. It is also useful in combating treatment-resistant depression. Compared to other mood stabilisers, lithium has a favourable efficacy-tolerability balance. Lithium is underused due to active marketing of alternatives and concerns regarding adverse effects, tolerability, and the perception that regular monitoring is difficult

Violin Plots as Visual Tools in the Meta-Analysis of Single-Case Experimental Designs

Despite the existence of sophisticated statistical methods, systematic reviews regularly indicate that single-case experimental designs (SCEDs) are predominantly analyzed through visual tools. For the quantitative aggregation of results, different meta-analytical techniques are available, but specific visual tools for the meta-analysis of SCEDs are lacking. The present article therefore describes the use of violin plots as visual tools to represent the raw data. We first describe the underlying rationale of violin plots and their main characteristics. We then show how the violin plots can complement the statistics obtained in a quantitative meta-analysis. The main advantages of violin plots as visual tools in meta-analysis are (a) that they preserve information about the raw data from each study, (b) that they have the ability to visually represent data from different designs in one graph, and (c) that they enable the comparison of score distributions from different experimental phases from different studies

Assessing Consistency in Single-Case Data Features Using Modified Brinley Plots

The current text deals with the assessment of consistency of data features from experimentally similar phases and consistency of effects in single-case experimental designs. Although consistency is frequently mentioned as a critical feature, few quantifications have been proposed so far: namely, under the acronyms CONDAP (consistency of data patterns in similar phases) and CONEFF (consistency of effects). Whereas CONDAP allows assessing the consistency of data patterns, the proposals made here focus on the consistency of data features such as level, trend, and variability, as represented by summary measures (mean, ordinary least squares slope, and standard deviation, respectively). The assessment of consistency of effect is also made in terms of these three data features, while also including the study of the consistency of an immediate effect (if expected). The summary measures are represented as points on a modified Brinley plot and their similarity is assessed via quantifications of distance. Both absolute and relative measures of consistency are proposed: the former expressed in the same measurement units as the outcome variable and the latter as a percentage. Illustrations with real data sets (multiple baseline, ABAB, and alternating treatments designs) show the wide applicability of the proposals. We developed a user-friendly website to offer both the graphical representations and the quantifications

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

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 post-discontinuation 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

The assessment of consistency in single-case experiments: Beyond A-B-A-B designs

Quality standards for single-case experimental designs (SCEDs) recommend inspecting six data aspects: level, trend, variability, overlap, immediacy, and consistency of data patterns. The data aspect consistency has long been neglected by visual and statistical analysts of SCEDs despite its importance for inferring a causal relationship. However, recently a first quantification has been proposed in the context of A-B-A-B designs, called CONsistency of DAta Patterns (CONDAP). In the current paper, we extend the existing CONDAP measure for assessing consistency in designs with more than two successive A-B elements (e.g., A-BA-B-A-B), multiple baseline designs, and changing criterion designs. We illustrate each quantification with published research

A proposal for the assessment of replication of effects in single-case experimental designs

In science in general and in the context of single-case experimental designs, replication of the effects of the intervention within and/or across participants or experiments is crucial for establishing causality and for assessing the generality of the intervention effect. Specific developments and proposals for assessing whether an effect has been replicated or not (or to what extent) are scarce, in the general context of behavioral sciences, and practically null in the singlecase experimental designs context. We propose an extension of the modified Brinley plot for assessing how many of the effects replicate. To make this assessment possible, a definition of replication is suggested, on the basis of expert judgment, rather than on statistical criteria. The definition of replication and its graphical representation are justified, presenting their strengths and limitations, and illustrated with real data. A user-friendly software is made available for obtaining automatically the graphical representation

Assessing Consistency in Single-Case Alternation Designs

Consistency is one of the crucial single-case data aspects that are expected to be assessed visually, when evaluating the presence of an intervention effect. Complementarily to visual inspection, there have been recent proposals for quantifying the consistency of data patterns in similar phases and the consistency of effects for reversal, multiple-baseline, and changing criterion designs. The current text continues this line of research by focusing on alternation designs using block randomization. Specifically, three types of consistency are discussed: consistency of superiority of one condition over another, consistency of the average level across blocks, and consistency in the magnitude of the effect across blocks. The focus is put especially on the latter type of consistency, which is quantified on the basis of partitioning the variance, as attributed to the intervention, to the blocking factor or remaining as residual (including the interaction between the intervention and the blocks). Several illustrations with real and fictitious data are provided in order to make clear the meaning of the quantification proposed. Moreover, specific graphical representations are recommend for complementing the numerical assessment of consistency. A freely available user-friendly webpage is developed for implementing the proposal

Single-case experimental designs:the importance of randomization and replication

Single-case experimental designs are rapidly growing in popularity. This popularity needs to be accompanied by transparent and well-justified methodological and statistical decisions. Appropriate experimental design including randomization, proper data handling and adequate reporting are needed to ensure reproducibility and internal validity. The degree of generalizability can be assessed through replication

Ethyl 1-sec-butyl-2-(4-methoxy­phen­yl)-1H-benzimidazole-5-carboxyl­ate

In the title mol­ecule, C21H24N2O3, the dihedral angle between the benzene and imidazole rings is 66.33 (13)°. The imidazole ring is essentially planar, with a maximum deviation of 0.004 (2) Å. In the crystal structure, mol­ecules are connected by weak C—H⋯O hydrogen bonds, forming chains along the b axi