Understanding and assessing potential serious adverse events: a practical approach to understanding the benefits and harm of psoriasis treatments.

Background: Any therapeutic intervention carries with it the potential for benefit and harm. Generally, benefit is far more common than risk; however, risk aversion drives many of the treatment decisions made by patients and their physicians.

Objective: To provide guidelines to help clinicians improve their understanding of causality and the interpretation of harm.

Canadian Alzheimer's disease caregiver survey: baby-boomer caregivers and burden of care.

Objective: Alzheimer's disease (AD) burdens not only the person, but also the person's caregiver(s). This burden has been linked to negative health effects for caregivers. To that end, a survey of Canadian caregivers of persons with AD/other dementias was conducted to investigate the social, physical, psychological and financial impact of AD and/or dementia-related conditions on caregivers' quality of life.

Adult ADHD and comorbid depression: A consensus-derived diagnostic algorithm for ADHD.

Objective: Many patients present to their physician with depression as their primary symptom. However, depression may mask other comorbid disorders. This article presents diagnostic criteria and treatment recommendations (and monitoring) pertaining to the diagnosis of adult attention deficit hyperactivity disorder (ADHD), which may be missed in patients who present with depressive symptoms, or major depressive disorder (MDD).

Persistence with cholinesterase inhibitor therapy for dementia: an observational administrative health database study.

Objective: To determine if choice of drug and ease of administration affect persistence of therapy with cholinesterase inhibitors (ChEIs) for treatment of dementia.

Methods: An observational administrative health database study was conducted in 5622 patients aged >or=65 years who received a new prescription for donepezil (DON), rivastigmine (RIV) or galantamine (GAL) from February to May 2006. Patients were followed for 1 year from initiation of therapy to determine percentage persistence and days of therapy.

100 years after Alzheimer: contemporary neurology practice assessment of referrals for dementia.

Background: The prevalence of dementia is placing an increased burden on specialists.

Methods: Canadian neurologists responded to a structured questionnaire to assess reasons for referral and services provided as well as to compare the neurologists' perceptions of their practice characteristics against cases seen over a 3-month period.

Results: The audit confirmed the participants' perception that family practitioners are the main referral source (358/453, 79%).

Osmotic-release oral system methylphenidate augmentation of antidepressant monotherapy in major depressive disorder: results of a double-blind, randomized, placebo-controlled trial.

Objective: To evaluate the efficacy, safety, and tolerability of adjunctive osmotic-release oral system (OROS) methylphenidate in outpatients with major depressive disorder (MDD) receiving a stable oral antidepressant regimen.

Method: This multicenter, double-blind, randomized, placebo-controlled, parallel-group, 5-week trial enrolled 145 subjects who met DSM-IV-TR criteria for MDD and who had failed 1 to 3 previous antidepressant monotherapies (including current antidepressant) of adequate dose and duration. Augmentation therapy was initiated with 18 mg of OROS methylphenidate and increased to a maximum dose of 54 mg of OROS methylphenidate until an optimal dose was achieved.

Do formulation switches exacerbate existing medical illness? Results of an open-label transition to orally disintegrating risperidone tablets.

Background: Orally disintegrating risperidone tablets (Risperdal* M-TABs*) present an alternative method of drug delivery that may benefit physicians struggling to treat non-compliant patients, since it begins to dissolve within 5 s, preventing tablet cheeking or spitting.

Objectives: To evaluate safety and maintenance of effect in symptomatically stable patients transitioned from compressed risperidone tablets to orally disintegrating risperidone tablets.

Methods: This open-label, multi-centre study enrolled 82 adults from four diagnostic groups (major depressive disorder (MDD), n = 25; bipolar disorder (BP), n = 21; dementia (DE), n = 20; schizophrenia (SZ), n = 16).

Does OROS-methylphenidate improve core symptoms and deficits in executive function? Results of an open-label trial in adults with attention deficit hyperactivity disorder.

Objective: This pilot, uncontrolled, open-label study evaluated the safety/tolerability and potential effectiveness of OROS-methylphenidate (OROS-MPH) in adult attention deficit hyperactivity disorder (ADHD).

Methods: Adults with DSM-IV-defined ADHD were enrolled in this 38-day study. Retrospective childhood diagnosis was made using the Wender Utah Rating Scale.

Management of psychiatric disorders in children and adolescents with atypical antipsychotics: a systematic review of published clinical trials.

We aimed to provide a descriptive review of treatment studies of atypical antipsychotics in paediatric psychiatric disorders. A systematic review of the literature used Medline and EMBASE databases to identify clinical trials of atypical antipsychotics in children and adolescents between 1994 and 2006. Trials were limited to double-blind studies and open-label studies of > or = 8 weeks duration that included > or = 20 patients.

Topiramate prophylaxis and response to triptan treatment for acute migraine.

Objective: To evaluate the effect of topiramate migraine prophylaxis on subject responsiveness to triptans used for acute symptomatic migraine treatment.

Background: Clinical experience suggests that prophylactic migraine treatment may enhance the efficacy of symptomatic medications used to treat acute migraine attacks.

Methods: This open-label, single-arm multicenter study consisted of a 6-week baseline period followed by a 16-week topiramate treatment period.

A randomized, controlled effectiveness trial of OROS-methylphenidate compared to usual care with immediate-release methylphenidate in attention deficit-hyperactivity disorder.

Background: The thrice daily dosing regimen of immediate release methylphenidate (IR-MPH) for Attention Deficit/Hyperactivity Disorder (ADHD) requires in-school dosing, leading to issues surrounding dispensing and storage of controlled substances by school personnel and concerns over children?s privacy and the embarrassment associated with taking medication in public at school. OROS-methylphenidate (OROS-MPH) is a once-daily controlled-release formulation of methylphenidate (MPH) developed to overcome some of the limitations associated with IR-MPH and first-generation sustained-release formulations. Randomized, controlled trials (RCTs) that focus on treatment efficacy provide the best evidence for demonstrating whether an intervention works, but under ideal conditions one cannot discount the importance of efficacy study results.

Risperidone reduces aggression in boys with a disruptive behaviour disorder and below average intelligence quotient: analysis of two placebo-controlled randomized trials.

The present study aimed to analyse the effect of risperidone on a priori defined core aggression items. Data were pooled from 163 boys (aged 5-12 years, with or without comorbid attention-deficit/hyperactivity disorder) with a DSM-IV diagnosis of either conduct disorder or oppositional defiant disorder who had participated in either of two identical, 6-week, randomized, double-blind, placebo-controlled trials. All received treatment with either placebo or oral risperidone solution (0.

Open-label adjunctive topiramate in the treatment of unstable bipolar disorder.

Objective: To assess open-label adjunctive topiramate in the treatment of outpatients with unstable bipolar disorder (BD).

Method: Outpatients with DSM-IV-defined BD (I or II) exhibiting mood instability were enrolled in this 16-week, open-label, multicentre study. Topiramate was added to existing mood stabilizers and other psychotropic treatments.

Galantamine treatment of problematic behavior in Alzheimer disease: post-hoc analysis of pooled data from three large trials.

Objective: The authors explored the effect of galantamine on behavioral symptoms in Alzheimer disease (AD).

Methods: Data were pooled from 2,033 subjects with mild-to-moderate AD who had participated in one of three randomized, double-blind, placebo-controlled trials of 3-, 5-, and 6-month durations. Subjects included in this post hoc analysis had received treatment with either placebo (N=686) or galantamine (N=1347) in total daily doses of 16 mg, 24 mg, or 32 mg.

Pharmacotherapy of disruptive behavior and item changes on a standardized rating scale: pooled analysis of risperidone effects in children with subaverage IQ.

Background: Disruptive behavior disorders (DBDs), excluding attention deficit/hyperactivity disorder (ADHD), are characterized by a repetitive pattern of antisocial, aggressive, and defiant behavior involving major violations of age-appropriate norms, resulting in significant functional impairment. Risperidone is licensed for the treatment of DBDs in children, adolescents, and adults in several countries. The aim of this study was to determine the effect of risperidone in a clinical setting on the symptom items of the Nisonger Child Behavior Rating Form (N-CBRF), used for the assessment of DBD patients.

Acceptability and disintegration rates of orally disintegrating risperidone tablets in patients with schizophrenia or schizoaffective disorder.

Objective: To investigate the disintegration profile, acceptability, and tolerability of orally disintegrating risperidone tablets in patients with schizophrenia or schizoaffective disorder.

Method: Ten patients stable for at least 10 days on monotherapy with oral risperidone 2 mg to 4 mg taken once daily were switched for 7 days to an equivalent dosage of orally disintegrating risperidone. Visual assessments for time to initial and complete disintegration were collected at each visit.

Risperidone effects in the presence/absence of psychostimulant medicine in children with ADHD, other disruptive behavior disorders, and subaverage IQ.

Objective: The aim of this study was to examine the safety and efficacy of risperidone, with or without concomitant psychostimulant use, in the treatment of children with conduct disorder (CD) or other disruptive behavior disorders [oppositional defiant disorder (ODD), disruptive behavior disorder-not otherwise specified (DBD-NOS)], and comorbid attention-deficit hyperactivity disorder (ADHD).

Methods: Data from two 6-week placebo-controlled trials assessing risperidone therapy in children with subaverage IQs and CD, ODD, DBD-NOS were combined, and patients with comorbid ADHD were selected for this post hoc analysis. Patients were grouped according to randomized drug therapy (risperidone or placebo), and then subgrouped according to their use of a concomitant psychostimulant.

Risperidone plus lithium versus risperidone plus valproate in acute and continuation treatment of mania.

This exploratory analysis was performed to compare the efficacy and tolerability of risperidone when added to two different mood stabilizers (lithium or valproate) for mania in bipolar disorder. Patients receiving lithium or valproate at baseline were drawn from the database of a 12-week, open-label risperidone study. The primary efficacy measure was the Young Mania Rating Scale (YMRS).

Prolactin levels during long-term risperidone treatment in children and adolescents.

Background: This analysis was designed to investigate prolactin levels in children and adolescents on long-term risperidone treatment and explore any relationship with side effects hypothetically attributable to prolactin (SHAP).

Method: Data from 5 clinical trials (total N = 700) were pooled for this post hoc analysis. Children and adolescents aged 5 to 15 years with subaverage intelligence quotients and conduct or other disruptive behavior disorders received risperidone treatment (0.

Risperidone in acute and continuation treatment of mania.

In a prospective study, we examined the efficacy of risperidone added-on to mood stabilizers in the acute and continuation treatment of mania over a 12-week period. Patients (n=108) with a DSM-IV diagnosis of bipolar disorder, manic or mixed episode requiring treatment with an antipsychotic were recruited. All subjects were on one or two mood stabilizers at the time of initiation of risperidone (range 0.

Effects of risperidone on conduct and disruptive behavior disorders in children with subaverage IQs.

Objective: To determine whether risperidone is effective in reducing symptoms of disruptive behaviors (such as aggression, impulsivity, defiance of authority figures, and property destruction) associated with conduct disorder, oppositional defiant disorder, and disruptive behavior disorder-not otherwise specified in children with subaverage IQs.

Method: The trial consisted of a 1-week, single-blind, placebo run-in period and was followed by a 6-week, double-blind, placebo-controlled period. One hundred ten children (aged 5-12 years inclusive) with an IQ of 36-84 with a disruptive behavior disorder and a score of at least 24 on the Conduct Problem subscale of the Nisonger Child Behavior Rating Form (NCBRF) were enrolled.

Long-term safety and efficacy of risperidone for the treatment of disruptive behavior disorders in children with subaverage IQs.

Objective: The objective of this study was to investigate the long-term safety and efficacy of risperidone in disruptive behavior disorders in children with subaverage IQs. Disruptive behavior disorders were defined as oppositional defiant disorder, disruptive behavior disorder, and conduct disorder as per the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria.

Methods: This was a 48-week open-label (OL) extension study of risperidone in 77 children diagnosed with a disruptive behavior disorder, and either borderline intellectual function or mild or moderate mental retardation who had participated in a previous 6-week, double-blind (DB) study and completed at least 2 weeks of DB therapy.