Time courses of improvement and symptom remission in children treated with atomoxetine for attention-deficit/hyperactivity disorder: analysis of Canadian open-label studies

<p>Abstract</p> <p>Background</p> <p>The relatively short durations of the initial pivotal randomized placebo-controlled trials involving atomoxetine HCl for the treatment of attention-deficit/hyperactivity disorder (ADHD) provided limited insight into the time courses of ADHD core symptom responses to this nonstimulant, selective norepinephrine reuptake inhibitor. The aim of this analysis was to evaluate time courses of treatment responses or remission, as assessed by attainment of prespecified scores on the ADHD Rating Scale-IV-Parent Version: Investigator Administered and Scored (ADHDRS-IV-PI) and the Clinical Global Impressions-ADHD-Severity (CGI-ADHD-S) scales, during up to 1 year of atomoxetine treatment in children with ADHD.</p> <p>Methods</p> <p>Using pooled data from three Canadian open-label studies involving 338 children ages 6-11 years with ADHD who were treated with atomoxetine for 3, 6 and 12 months, and survival analysis methods for interval-censored data, we estimated the time to: 1) improvement and robust improvement defined by ≥25% and ≥40% reductions from baseline ADHDRS-IV-PI total scores, respectively; and 2) remission using two definitions: a final score of ADHDRS-IV-PI ≤18 or a final score of CGI-ADHD-S ≤2.</p> <p>Results</p> <p>The median time to improvement was 3.7 weeks (~1 month), but remission of symptoms did not occur until a median of 14.3 weeks (~3.5 months) using the most stringent CGI-ADHD-S threshold. Probabilities of robust improvement were 47% at or before 4 weeks of treatment; 76% at 12 weeks; 85% at 26 weeks; and 96% at 52 weeks. Probabilities of remission at these corresponding time points were 30%, 59%, 77%, and 85% (using the ADHDRS-IV scale) and 8%, 47%, 67%, and 75% (using the CGI-ADHD-S scale). The change from atomoxetine treatment month 5 to month 12 of -1.01 (1.03) was not statistically significant (<it>p </it>= .33).</p> <p>Conclusions</p> <p>Reductions in core ADHD symptoms during atomoxetine treatment are gradual. Although approximately one-half of study participants showed improvement at 1 month of atomoxetine treatment, remission criteria were not met until about 3 months. Understanding the time course of children's responses to atomoxetine treatment may inform clinical decision making and also influence the durations of trials comparing the effects of this medication with other ADHD treatments.</p> <p>Trial Registrations</p> <p>clinicaltrials.gov: <a href="http://www.clinicaltrials.gov/ct2/show/NCT00191633">NCT00191633</a>, <a href="http://www.clinicaltrials.gov/ct2/show/NCT00216918">NCT00216918</a>, <a href="http://www.clinicaltrials.gov/ct2/show/NCT00191880">NCT00191880</a>.</p

Psychological consultancy in mental health services: A systematic review of service, staff, and patient outcomes

Objectives Psychological consultation in mental health is an organizational intervention aiming to enable mental health care to be delivered in a more efficient manner. This review sought to: (1) clarify what theoretical models underpin consultancy, (2) define how consultancy is implemented, (3) assess the methodological rigour of the evidence base, and (4) define the outcomes achieved for services, staff, and patients. The review was focal to direct and indirect forms of consultation. Method PRISMA guidelines were followed. Three databases were searched identifying N = 17 studies, and these were quality assessed using the QualSyst quality ratings checklist. Studies were grouped by model of consultation and outcome. A thematic analysis then clustered the patient, staff, and service outcomes into either discrepant or confirmatory evidence. Results The most frequently adopted theoretical models underpinning psychological consultation are cognitive‐behavioural and cognitive‐analytic. Method of consultancy implementation is typically via case formulation meetings. Study quality varied from limited to strong. The main confirmatory and positive outcomes for staff are an increase in understanding and also more positive feelings towards patients, and for the service, there is a reduced need for other interventions. Conclusions Psychological consultation appears a useful and worthwhile aspect of leadership by psychological therapists. Training in delivering consultancy needs to be well integrated into the core curricula of clinical training programmes. The evidence base is still in its infancy, and further well‐controlled research is required. Practitioner points Psychological consultation improves staff insight and understanding of patients. Psychological consultants need to remain visible and accessible to teams and use a theoretical model to guide consultation. Training and supervision in consultation are necessary to support psychological therapists in these roles