No significant relationships.

Previously, we reported the clinical efficacy of MPH-LA in adult ADHD evaluated in a 40-week, randomised, double-blind, placebo-controlled, multicentre core study [comprising of dose confirmation (9-week), real-life dose optimisation (5-week) and maintenance of effect phases (6- month)] (Atten Defic Hyperact Disord. 2013;(5):219–220). Here, we report the long-term efficacy from the 26-week extension phase of the same study.

During the extension phase, patients initiated treatment with MPH-LA 20 mg/day (oral, once daily capsules); uptitrated to optimal dose of 40, 60 or 80 mg/day in increments of 20 mg/week. Change in DSM-IV ADHD rating scale (RS) and SDS total scores at the end of study, were evaluated from the baseline of maintenance of effect phase of the core study and the baseline of extension phase.

At the end of the extension phase, the mean change in DSM-IV ADHD RS and SDS total scores from baseline of the maintenance of effect phase was −0.9 and −1.4 points respectively; and from baseline of extension phase was −7.2 and −4.8 respectively (Table). No new or unexpected safety concerns were observed during the extension phase.

MPH-LA continued to maintain clinical efficacy in adult ADHD patients over long-term.

Table DSM-IV ADHD RS, SDS total scores and change from baseline at the end of extension phase

A previous 40-week, randomised, double-blind placebo-controlled core study [comprising of dose confirmation (9-week), real-life dose optimisation (5-week) and maintenance of effect phases (6-month)] reported the safety of MPH-LA in the treatment of adult ADHD. Here, we report the long-term safety from the extension phase (6-month) of this core study.

During the extension phase, patients initiated treatment with MPH-LA 20 mg/day; up-titrated to an optimal dose of 40, 60 or 80 mg/day in increments of 20 mg/week. Safety was analysed from baseline of maintenance of effect phase (core study); and from baseline of extension phase to end of extension phase. Adverse events (AEs) and serious adverse events (SAEs) were reported.

Incidence of AEs occurring anytime starting from baseline of the maintenance of effect phase (core study) until the end of extension phase was 80.5%. The incidence of AEs occurring in the extension phase period was 69.8% (Table). Incidence of serious AEs (SAEs) reported during both periods were similar (0.7%). Most common AEs were nasopharyngitis, headache, decreased appetite, dry mouth and nausea. No deaths were reported. No new or unexpected results were observed for laboratory findings, vital signs or ECGs. None of the patients had QT, QTcB or QTcF ≥500ms during the study.

Long-term treatment with MPH-LA in adult ADHD patients was well-tolerated.

Table: Number (%) of patients with most frequent AEs and SAEs

Recent epidemiology studies have reported the prevalence of adult ADHD to be approximately 4%, however approved treatments are limited.

Primary objectives were to confirm the clinically-effective and safe dosage range of MPH-LA in adults with ADHD and evaluate the 6-month maintenance of effect.

Treatment Period (TP) 1: Patients were randomized to double-blind placebo, MPH-LA 40, 60, or 80 mg/day for 9- weeks (3-week titration, 6-week fixed-dose) to evaluate change in DSM-IV ADHD-RS and Sheehan Disability Scale (SDS) total score in TP1. TP2: 5-week titration to individual optimal dose. TP3: Patients were randomized to their optimal dose or placebo for 6-months double-blind withdrawal period to evaluate percentage of treatment failures during TP3.

Improvement from baseline in total score on the DSM-IV ADHD-RS and SDS was significantly greater than placebo for all MPH-LA dose levels (table). Patients treated with MPH-LA had significantly lower treatment failure rates (21.34%) compared to placebo in TP3 (49.6%; odds-ratio (95%CI=0.3 (0.2, 0.4); p< 0.0001). The safety results were consistent with the established safety profile for MPH-LA.

[Improvement by week 9: DSM-IV ADHD-RS and SDS].

MPH-LA administered at 40-80mg/day demonstrated superior ADHD symptom control and reduction in functional impairment compared to placebo and demonstrated maintenance of effect over 6 months. No unexpected adverse events were observed.

The safety profile of MPH-LA in the paediatric population has been well studied. However, there are very limited studies reporting safety of MPH-LA in adults. We present the safety profile of MPH-LA in adults and from a pooled analysis in children.

Data from 3 multiple-dose, double-blind, placebo-controlled studies of 7-12 weeks duration in children with ADHD; MPH-LA (10-80mg/d) (n=314) & placebo (n=318) (aged 6-12 yrs in 2 studies &13-17 yrs in one study) were pooled for this analysis. In addition, data from 722 adult patients, 18-60 yrs of age with ADHD receiving MPH-LA 40-80 mg/d (n=542) or placebo (n=180) from double-blind dose confirmation phase of 9-week duration from one study was included in the analysis.

Common adverse events (AEs) reported by both adult and paediatric ADHD patients were decreased appetite, headache, nasopharyngitis, nausea, and insomnia (Table). Incidence of serious AEs (SAEs) was low with MPH-LA in both adults (0.7%) and children (0.6%) compared with placebo group (1.1% in adults and 0.3% in children).

Our findings show that safety profile of MPH-LA in adults is similar to that observed in the paediatric population.

Table

Adverse events (>5%) by preferred term in multiple dose, placebo-controlled studies In adult and paedlatrlc ADHD patients

ADHD is associated with pervasive cognitive, emotional and functional impairments and increased rates of coexisting disorders. Epidemiological studies indicate 25-45% of prison inmates to have ADHD. However, ADHD is often unrecognised in prison inmates and stimulant treatment was not previously evaluated in this group.

Provide effective treatment for prison inmates established with ADHD.

Evaluate efficacy and long-term effectiveness of osmotic-release oral system methylphenidate (OROS-MPH) in adult male long-term prison inmates with ADHD.

A 5-week randomised, double-blind, placebo-controlled, fixed-dose (72 mg/d) trial was conducted in 30 prison inmates with ADHD and coexisting disorders. In a following 47-week open-label extension (OLE), flexible-dosing OROS-MPH was provided alongside psychosocial interventions within a high-security Swedish prison. Primary outcome was change in ADHD symptoms after 5 weeks (CAARS: O-SV). Secondary outcomes included self-reported ADHD symptoms, global severity, global functioning, cognition, motor activity, institutional behaviour and quality of life.

OROS-MPH was highly effective and overall safe, both in the short-term relative to placebo (Cohen’s d=2.17; NNT=1.1), and in the long-term when provided alongside psychosocial interventions. Treatment continued to improve ADHD symptoms, global functioning, motor activity, cognition, quality of life, and behaviour control over the 47-week OLE. No drug misuse was reported and a majority of participants completed rehabilitation programs.

OROS-MPH effectively improved symptoms and functional impairments of ADHD in prison inmates with ADHD. We suggest that OROS-MPH provided alongside rehabilitation programs could be a feasible and effective multimodal intervention for adults with ADHD and coexisting disorders within a prison setting

Background Attention-deficit/hyperactivity disorder (ADHD) is among the most common psychiatric disorders of childhood that often persists into adulthood and old age. Yet ADHD is currently underdiagnosed and undertreated in many European countries, leading to chronicity of symptoms and impairment, due to lack of, or ineffective treatment, and higher costs of illness.

Methods The European Network Adult ADHD and the Section for Neurodevelopmental Disorders Across the Lifespan (NDAL) of the European Psychiatric Association (EPA), aim to increase awareness and knowledge of adult ADHD in and outside Europe. This Updated European Consensus Statement aims to support clinicians with research evidence and clinical experience from 63 experts of European and other countries in which ADHD in adults is recognized and treated.

Results Besides reviewing the latest research on prevalence, persistence, genetics and neurobiology of ADHD, three major questions are addressed: (1) What is the clinical picture of ADHD in adults? (2) How should ADHD be properly diagnosed in adults? (3) How should adult ADHDbe effectively treated?

Conclusions ADHD often presents as a lifelong impairing condition. The stigma surrounding ADHD, mainly due to lack of knowledge, increases the suffering of patients. Education on the lifespan perspective, diagnostic assessment, and treatment of ADHD must increase for students of general and mental health, and for psychiatry professionals. Instruments for screening and diagnosis of ADHD in adults are available, as are effective evidence-based treatments for ADHD and its negative outcomes. More research is needed on gender differences, and in older adults with ADHD.