Efficacy of shared decision-making on treatment adherence of patients with bipolar disorder: a cluster randomized trial (ShareD-BD).

BACKGROUND: Shared decision-making (SDM) is a model of interaction between doctors and patients in which both actors contribute to the medical decision-making process. SDM has raised great interest in mental healthcare over the last decade, as it is considered a fundamental part of patient-centered care. However, there is no research evaluating the efficacy of SDM compared to usual care (CAU), as it relates to quality of care and more specifically treatment adherence, in bipolar disorder (BD). METHODS/DESIGN: This is a 12-month multi-centre, cluster-randomized controlled trial comparing the efficacy of SDM to CAU. Adult BD patients (n = 300) will be eligible after stabilization for at least 4 weeks following an acute mood episode. The intervention will consist of applying the standardized SDM process as developed by the Ottawa Hospital Research Institute in order to choose the maintenance treatment of BD. A multidisciplinary team developed a decision aid "choose my long-term treatment with my doctor" for BD patients to clarify possible therapeutic options. Primary outcome will assess the patient's level of adherence (based on hetero-evaluation) of ongoing treatment at 12 months. Secondary outcomes will assess the difference between the 2 groups of patients in terms of adherence to maintenance drug therapy based on other measures (self-assessment scale and plasma levels of mood stabilizers). Additionally, other dimensions will be assessed: decisional conflict, satisfaction with care and involvement in decision making, beliefs about treatment, therapeutic relationship, knowledge about information for medical decision and clinical outcomes (depression, mania, functioning and quality of life). The primary endpoint will be analysed without adjustment by comparison of adherence scores between the two groups using Student t-tests or Mann-Whitney tests according to the variable distribution. A set of secondary analyses will be adjusted for covariates of clinical interest using generalized linear mixed regression models. DISCUSSION: This will be the first study evaluating the effect of an SDM intervention on patient adherence in BD. This is also an innovative protocol because it proposes the development of an evidence-based tool that should help patients and clinicians to initiate discussions regarding the use of BD treatment. TRIAL REGISTRATION: The study has been registered with ClinicalTrials.gov as NCT03245593 .

[Long-term efficacy and safety of lurasidone in the treatment of schizophrenia]. / Efficacité et tolérance à long terme de la lurasidone dans la prise en charge de la schizophrénie.

Lurasidone is a new second-generation antipsychotic approved in March 2014 by the European Medicines Agency for the treatment of schizophrenia. Lurasidone has demonstrated its efficacy in long-term studies. It has been shown to reduce significantly the risk of relapse in comparison with placebo in patients with schizophrenia. In comparator study, lurasidone was noninferior to quetiapine XR in risk for relapse. In open-label studies, lurasidone was associated with sustained improvement in efficacy measures observed and well-tolerated inpatients with schizophrenia who had switched to lurasidone from another antipsychotic. Available evidence showed also that lurasidone might be involved in the long-term improvement of cognitive performance in schizophrenic patients. Lurasidone differs from the other second-generation antipsychotics by a good tolerability profile, in particular in terms of metabolic and cardiovascular profiles. Lurasidone seems to have a moderate link with the occurrence of akathisia and extrapyramidal symptoms. Although lurasidone long-acting formulation is lacking, the long-term profile of lurasidone appears compatible with a good acceptability and consequently a good compliance to treatment of patients with schizophrenia.