A meta-analysis of the consistency of atomoxetine treatment effects in pediatric patients with attention-deficit/hyperactivity disorder from 15 clinical trials across four geographic regions.

Objective: Atomoxetine has been approved as a treatment for children and adolescents with attention-deficit/hyperactivity disorder (ADHD) in the United States, throughout Europe, and in other countries. This meta-analysis was to assess the consistency of the treatment effect of atomoxetine across four global geographic regions.

Methods: Data from 15 acute, double-blind, placebo-controlled trials were pooled (2 in Asia, 4 in Europe, 8 in North America, and 1 in Russia), yielding 2569 pediatric patients with ADHD.

Treatment-completion rates with olanzapine long-acting injection versus risperidone long-acting injection in a 12-month, open-label treatment of schizophrenia: indirect, exploratory comparisons.

Background: Little is known about the comparative effectiveness of atypical antipsychotics in long-acting injection formulation. Due to the absence of head-to-head studies comparing olanzapine long-acting injection and risperidone long-acting injection, this study was intended to make exploratory, indirect, cross-study comparisons between the long-acting formulations of these two atypical antipsychotics in their effectiveness in treating patients with schizophrenia.

Methods: Indirect, cross-study comparisons between olanzapine long-acting injection and risperidone long-acting injection used 12-month treatment-completion rates, because discontinuation of an antipsychotic for any cause is a recognized proxy measure of the medication's effectiveness in treating schizophrenia.

Comparison of patients undergoing switching versus augmentation of antipsychotic medications during treatment for schizophrenia.

It is often difficult to determine whether a patient may best benefit by augmenting their current medication or switching them to another. This post-hoc analysis compares patients' clinical and functional profiles at the time their antipsychotic medications were either switched or augmented. Adult outpatients receiving oral antipsychotic treatment for schizophrenia were assessed during a 12-month international observational study.

Responses to antipsychotic therapy among patients with schizophrenia or schizoaffective disorder and either predominant or prominent negative symptoms.

Patients with schizophrenia who have predominant negative symptoms are often considered less responsive to treatment. This analysis of patients with schizophrenia or schizoaffective disorder compares changes in symptom severity between those with predominant versus merely prominent negative symptoms. Prominent negative symptoms were defined by a baseline score of ≥4 on at least 3, or ≥5 on at least 2, of the 7 Positive and Negative Syndrome Scale (PANSS) negative subscale items.

Comparison of metabolic changes in patients with schizophrenia during randomized treatment with intramuscular olanzapine long-acting injection versus oral olanzapine.

Metabolic changes were examined in patients with schizophrenia during treatment with either oral olanzapine or olanzapine long-acting injection (LAI). Data were collected from patients who had been stabilized on oral olanzapine (10, 15, or 20 mg/day) for ≥4 weeks and then randomized to either continued olanzapine oral treatment (n = 322) or LAI (n = 599; 150 mg/2 weeks, 405 mg/4 weeks, or 300 mg/2 weeks) for up to 24 weeks. Mean and categorical changes in metabolic parameters were analyzed.

Factors associated with adherence to treatment with olanzapine and other atypical antipsychotic medications in patients with schizophrenia.

Objectives: Poor treatment response is an important factor contributing to lack of treatment adherence. The goals of this research were to determine whether improvements in Positive and Negative Syndrome Scale (PANSS) symptom domains predict the likelihood of staying on treatment and whether differential responses to treatment with various atypical antipsychotics in specific symptom domains account for differences in discontinuation rates or treatment adherence.

Methods: We conducted a post-hoc analysis of pooled data from 5 randomized, double-blind, 24- to 28-week clinical trials in 1103 olanzapine-treated and 1090 risperidone-, quetiapine-, ziprasidone-, or aripiprazole-treated adult patients with schizophrenia.

Patient perspectives on antipsychotic treatments and their association with clinical outcomes.

This analysis examined patient-reported attitudes toward antipsychotic medication and the relationship of these attitudes with clinical outcomes and pharmacotherapy adherence. The analysis included three randomized, double-blind studies in patients with schizophrenia, schizoaffective disorder, or schizophreniform disorder diagnosed according to the Diagnostic and Statistical Manual of Mental Disorders 4th Edition and randomly assigned to treatment with olanzapine 5-20 mg/day or another antipsychotic (haloperidol 2-20 mg/day, risperidone 2-10 mg/day, or ziprasidone 80-160 mg/day). Patient-reported improvements were significantly greater for olanzapine (n = 488) versus other treatments (haloperidol n = 145, risperidone n = 158, or ziprasidone n = 271) on multiple Drug Attitude Inventory items.

Atomoxetine augmentation of cholinesterase inhibitor therapy in patients with Alzheimer disease: 6-month, randomized, double-blind, placebo-controlled, parallel-trial study.

Objectives: To examine the efficacy and tolerability of atomoxetine (ATX) in improving cognitive performance of patients with Alzheimer dementia.

Design: A randomized, double-blind, placebo (PLA)-controlled, parallel-groups study, starting with a 5-33-day screening and evaluation period, followed by a 6-month treatment period.

Setting: Eight independent or academic outpatient clinics in the United States.

Comparison of symptomatic versus functional changes in children and adolescents with ADHD during randomized, double-blind treatment with psychostimulants, atomoxetine, or placebo.

Background: This meta-analysis was designed to determine the relationship between reduction of attention-deficit/hyperactivity disorder (ADHD) symptoms and improvement in functioning by examining short-term changes in functional and symptomatic scores in children and adolescents with ADHD.

Methods: Search of atomoxetine's clinical trial database identified four studies involving a symptomatic measure, the ADHD Rating Scale-IV-Parent Version:Investigator-administered and -scored (ADHDRS-IV-Parent:Inv), and a functional measure, the Life Participation Scale for ADHD (LPS).

Results: Correlation analysis revealed a moderate-to-strong association between changes in the LPS total versus ADHDRS-IV-Parent:Inv total (r: -.

Effects of atomoxetine on growth in children with attention-deficit/hyperactivity disorder following up to five years of treatment.

Objective: To examine the effects on growth of long-term pharmacological treatment for attention-deficit/hyperactivity disorder (ADHD), we present findings from an ongoing 5-year study of the efficacy and safety of treatment with atomoxetine.

Methods: North American patients, 6-17 years old at study entry (N = 1,312) and with Diagnostic and Statistical Manual of Mental Disorders,4th edition (DSM-IV) ADHD, were studied under open-label atomoxetine treatment. Sixty-one were studied up to 5 years.

Atomoxetine treatment of ADHD in children with comorbid Tourette syndrome.

Objective: This study examines changes in severity of tics and ADHD during atomoxetine treatment in ADHD patients with Tourette syndrome (TS).

Method: Subjects (7-17 years old) with ADHD (Diagnostic and Statistical Manual of Mental Disorders, DSM-IV) and TS were randomly assigned to double-blind treatment with placebo (n = 56) or atomoxetine (0.5-1.

CYP2D6 metabolizer status and atomoxetine dosing in children and adolescents with ADHD.

To determine whether physicians can adequately titrate atomoxetine without knowing genotype status for hepatic cytochrome P450 2D6, we pooled data from two open-label studies of atomoxetine in children and adolescents with attention-deficit/hyperactivity disorder. Patients were assessed weekly up to 10 weeks and doses titrated for efficacy and tolerability at the discretion of investigators (max. 1.

Transition from methylphenidate or amphetamine to atomoxetine in children and adolescents with attention-deficit/hyperactivity disorder--a preliminary tolerability and efficacy study.

Background: The primary treatment for attention-deficit/hyperactivity disorder (ADHD) has been psychostimulants. Recently developed nonpsychostimulant treatments have allowed certain patients to switch from a psychostimulant to a nonpsychostimulant. However, the outcomes of such switches have not been systematically studied.

Effect of two different methods of initiating atomoxetine on the adverse event profile of atomoxetine.

Objective: To compare the effects of two different methods for initiating atomoxetine in terms of the incidence of early adverse events.

Method: Data on atomoxetine treatment-emergent adverse events in youths, ages 6 to 18 years, were analyzed from five randomized, double-blind, placebo-controlled, acute-phase studies. Two studies involve once-daily dosing and titration to 1.

Effect of comorbid symptoms of oppositional defiant disorder on responses to atomoxetine in children with ADHD: a meta-analysis of controlled clinical trial data.

Rationale: Up to 60% of children with attention-deficit/hyperactivity disorder (ADHD) suffer from comorbid affective or behavioral impairments, the most common condition being oppositional defiant disorder (ODD), which occurs in 40-60% of children with ADHD.

Objectives: This post hoc meta-analysis was performed to determine the effect of the presence of comorbid ODD symptoms on clinical outcomes among pediatric and adolescent subjects being treated for ADHD.

Methods: Acute-phase data were analyzed from three randomized, double-blind, placebo-controlled studies in outpatients aged 6-16 and meeting the Diagnostic and Statistical Manual of Mental Disorders, fourth edition, criteria for ADHD.

Effects of long-term atomoxetine treatment for young children with attention-deficit/hyperactivity disorder.

Objective: The purpose of this 13-study (seven double-blind/placebo-controlled, six open-label) meta-analysis is to determine the effectiveness and tolerability of long-term atomoxetine treatment among young children with attention-deficit/hyperactivity disorder (ADHD).

Method: Data were pooled from 6- and 7-year-olds (N = 272) who met DSM-IV criteria for ADHD, received atomoxetine treatment, and were enrolled in clinical trials of > or =2 years. Of these, 97 subjects reached the 24-month time point, providing data for long-term trend analysis of safety and effectiveness.

Long-term atomoxetine treatment in adolescents with attention-deficit/hyperactivity disorder.

Objective: To determine the efficacy and safety of atomoxetine in adolescent subjects treated for attention-deficit/hyperactivity disorder (ADHD) for up to 2 years.

Study Design: Data from 13 atomoxetine studies (6 double-blind, 7 open-label) were pooled for subjects age 12 to 18 with ADHD as defined by the American Psychiatric Association's Diagnostic and Statistical Manual of Mental Disorders IV.

Results: Of the 601 atomoxetine-treated subjects in this meta-analysis, 537 (89.

Drug-induced psychosis in Parkinson disease: phenomenology and correlations among psychosis rating instruments.

Objectives: To describe further the phenomenology of drug-induced psychosis (DIP) in patients with Parkinson disease (PD) and assess which items on two common psychosis rating instruments-the Brief Psychiatric Rating Scale (BPRS) and the Neuropsychiatric Inventory (NPI)-are the best measure of DIP by comparing them with the Clinical Global Impression Scale (CGIS).

Methods: Baseline data from two placebo-controlled, double-blind studies of olanzapine in PD patients with DIP were collected and analyzed.

Results: A total of 157 of 160 patients had hallucinations, with visual hallucinations being the most common (97% of subjects), followed by auditory (48%), tactile (23%), and olfactory (16%).

Comparison of olanzapine and risperidone in the treatment of psychosis and associated behavioral disturbances in patients with dementia.

Objective: The authors compared efficacy of olanzapine versus placebo and risperidone as measured by the Neuropsychiatric Inventory and Clinical Global Impression-Severity of Psychosis scale in patients with dementia-related psychosis.

Methods: Patients with moderate-to-severe psychotic symptoms associated with dementia were recruited from outpatient or residential settings and randomly assigned to 10-week, double-blind, flexible-dose treatment with olanzapine (N=204; 2.5 mg-10 mg/day; mean: 5.

Relapse prevention in bipolar I disorder: 18-month comparison of olanzapine plus mood stabiliser v. mood stabiliser alone.

Background: Few controlled studies have examined the use of atypical antipsychotic drugs for prevention of relapse in patients with bipolar I disorder. Aims To evaluate whether olanzapine plus either lithium or valproate reduces the rate of relapse, compared with lithium or valproate alone.

Method: Patients achieving syndromic remission after 6 weeks'treatment with olanzapine plus either lithium (0.

Olanzapine versus placebo in the treatment of psychosis with or without associated behavioral disturbances in patients with Alzheimer's disease.

Objectives: Psychotic symptoms and behavioral disturbances are a concern in the care of elderly patients with Alzheimer's dementia (AD). This study was conducted to compare the efficacy of olanzapine versus placebo in patients with psychotic symptoms associated with AD in long-term or continuing-care settings.

Methods: Patients (n = 652) with AD and delusions or hallucinations were randomly assigned to 10 weeks of double-blind treatment with placebo or fixed-dose olanzapine (1.

Retrospective cohort study of diabetes mellitus and antipsychotic treatment in a geriatric population in the United States.

Objectives: The objective of this study was to investigate risk of diabetes among elderly patients during treatment with antipsychotic medications.

Design: We conducted a longitudinal, retrospective study assessing the incidence of new prescription claims for antihyperglycemic agents during antipsychotic therapy.

Setting: Prescription claims from the AdvancePCS claim database were followed for 6 to 9 months.

Olanzapine versus clozapine in treatment-resistant or treatment-intolerant schizophrenia.

Clozapine has been the gold standard for treatment of patients with refractory schizophrenia but is associated with serious safety liabilities. This has prompted the search for therapeutic alternatives for treatment-resistant schizophrenia. The objective of this study was to compare the efficacy and safety of olanzapine versus clozapine in schizophrenic patients who failed to respond adequately to antipsychotic medication or who experienced intolerable adverse effects associated with the medication.

Comparison of risperidone and olanzapine in the control of negative symptoms of chronic schizophrenia and related psychotic disorders in patients aged 50 to 65 years.

Background: This analysis compares the efficacy of risperidone and olanzapine in controlling negative and positive symptoms of chronic psychosis in older patients.

Method: Post hoc assessments were made in a subset of risperidone-treated (N = 19) and olanzapine-treated (N = 20) older patients (aged 50 to 65 years) from a large international, multicenter, parallel, double-blind, 28-week study of patients aged 18 to 65 years (N = 339) randomly assigned to receive risperidone (4-12 mg/day) or olanzapine (10-20 mg/day). Assessments were made using repeated-measures analysis.