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Prior trials suggest that intravenous racemic ketamine is a highly effective for treatment-resistant depression (TRD), but phase 3 trials of racemic ketamine are needed.
To assess the acute efficacy and safety of a 4-week course of subcutaneous racemic ketamine in participants with TRD. Trial registration: ACTRN12616001096448 at www.anzctr.org.au.
This phase 3, double-blind, randomised, active-controlled multicentre trial was conducted at seven mood disorders centres in Australia and New Zealand. Participants received twice-weekly subcutaneous racemic ketamine or midazolam for 4 weeks. Initially, the trial tested fixed-dose ketamine 0.5 mg/kg versus midazolam 0.025 mg/kg (cohort 1). Dosing was revised, after a Data Safety Monitoring Board recommendation, to flexible-dose ketamine 0.5–0.9 mg/kg or midazolam 0.025–0.045 mg/kg, with response-guided dosing increments (cohort 2). The primary outcome was remission (Montgomery-Åsberg Rating Scale for Depression score ≤10) at the end of week 4.
The final analysis (those who received at least one treatment) comprised 68 in cohort 1 (fixed-dose), 106 in cohort 2 (flexible-dose). Ketamine was more efficacious than midazolam in cohort 2 (remission rate 19.6% v. 2.0%; OR = 12.1, 95% CI 2.1–69.2, P = 0.005), but not different in cohort 1 (remission rate 6.3% v. 8.8%; OR = 1.3, 95% CI 0.2–8.2, P = 0.76). Ketamine was well tolerated. Acute adverse effects (psychotomimetic, blood pressure increases) resolved within 2 h.
Adequately dosed subcutaneous racemic ketamine was efficacious and safe in treating TRD over a 4-week treatment period. The subcutaneous route is practical and feasible.
Relational cost analysis aims at formally establishing bounds on the difference in the evaluation costs of two programs. As a particular case, one can also use relational cost analysis to establish bounds on the difference in the evaluation cost of the same program on two different inputs. One way to perform relational cost analysis is to use a relational type-and-effect system that supports reasoning about relations between two executions of two programs. Building on this basic idea, we present a type-and-effect system, called ARel, for reasoning about the relative cost (the difference in the evaluation cost) of array-manipulating, higher order functional-imperative programs. The key ingredient of our approach is a new lightweight type refinement discipline that we use to track relations (differences) between two mutable arrays. This discipline combined with Hoare-style triples built into the types allows us to express and establish precise relative costs of several interesting programs that imperatively update their data. We have implemented ARel using ideas from bidirectional type checking.
Relational program verification is a variant of program verification where one can reason about two programs and as a special case about two executions of a single program on different inputs. Relational program verification can be used for reasoning about a broad range of properties, including equivalence and refinement, and specialized notions such as continuity, information flow security, or relative cost. In a higher-order setting, relational program verification can be achieved using relational refinement type systems, a form of refinement types where assertions have a relational interpretation. Relational refinement type systems excel at relating structurally equivalent terms but provide limited support for relating terms with very different structures. We present a logic, called relational higher-order logic (RHOL), for proving relational properties of a simply typed λ-calculus with inductive types and recursive definitions. RHOL retains the type-directed flavor of relational refinement type systems but achieves greater expressivity through rules which simultaneously reason about the two terms as well as rules which only contemplate one of the two terms. We show that RHOL has strong foundations, by proving an equivalence with higher-order logic, and leverage this equivalence to derive key meta-theoretical properties: subject reduction, admissibility of a transitivity rule, and set-theoretical soundness. Moreover, we define sound embeddings for several existing relational type systems such as relational refinement types and type systems for dependency analysis and relative cost, and we verify examples that were out of reach of prior work.
Deepak Garg, Consultant Psychiatrist (Perinatal and Liaison Psychiatry), Humber NHS Foundation Trust, Hull, UK,
Rajdeep Sandhu, Senior House Officer/Core Trainee Year 1 in Medicine at Staffordshire General Hospital, Stafford, UK
To investigate, through a semi-qualitative survey at three geographical sites, health professionals' and service users' opinion about the impact of providing separate consultants for in-patient and community settings. It looked at the perceived affect on various issues such as the course of the illness, service delivery, patients' satisfaction as well as the skills and training of psychiatrists.
Opinion was divided about the level of satisfaction, advantages, consultants' skills and success of this model. The most consistent theme related to the problems with the continuation of care and therapeutic relationship. Most of the respondents were not fully informed about this change. An overwhelming majority believed that in-patient psychiatry is not a separate specialty.
Communication and the sharing of information between the two consultants is the key to success in this model.
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