Clinical outcomes after local field conformal reirradiation of patients with retropharyngeal nodal metastasis.

Background: The purpose of this study was to present our experience with retropharyngeal node reirradiation using highly conformal radiotherapy (RT).

Methods: A retrospective screen of 2504 consecutively irradiated patients with head and neck malignancies between 2005 and 2015 identified 19 patients who underwent reirradiation for retropharyngeal node metastasis. Clinical and toxicity outcomes were assessed in these patients.

The safety and effectiveness of open-label extended-release carbamazepine in the treatment of children and adolescents with bipolar I disorder suffering from a manic or mixed episode.

Objective: To assess the safety and effectiveness of open-label treatment with extended-release carbamazepine (ERC) in pediatric subjects suffering from bipolar I disorder.

Method: Medically healthy youths aged 10-17 years suffering from an acute manic or mixed episode were eligible. After screening for study eligibility, the youths began a 5-week titration period in which doses of ERC were adjusted in order to optimize benefit whilst minimizing adverse events, at doses between 200-1,200 mg/day.

STX209 (arbaclofen) for autism spectrum disorders: an 8-week open-label study.

STX209 (arbaclofen), a selective GABA-B agonist, is hypothesized to modulate the balance of excitatory to inhibitory neurotransmission, and has shown preliminary evidence of benefit in fragile X syndrome. We evaluated its safety, tolerability, and efficacy in non-syndromic autism spectrum disorders, in an 8-week open-label trial enrolling 32 children and adolescents with either Autistic Disorder or Pervasive Developmental Disorder-Not Otherwise Specified, and a score ≥17 on the Aberrant Behavior Checklist (ABC)-Irritability subscale. STX209 was generally well-tolerated.

Parent-reported executive function behaviors and clinician ratings of attention-deficit/hyperactivity disorder symptoms in children treated with lisdexamfetamine dimesylate.

Objective: The purpose of this article was to describe the relationships between parent-rated executive function (EF) and clinician-rated attention-deficit/hyperactivity disorder (ADHD) symptoms before and after lisdexamfetamine dimesylate (LDX) treatment in children with and without EF deficit.

Methods: In post-hoc analyses of children with ADHD who participated in a 7 week open-label, dose-optimized (LDX 20-70 mg/day) trial, ADHD Rating Scale-IV (ADHD-RS-IV) change scores were compared (using two-sample t tests) between youth with and without clinically significant EF impairment at baseline. Clinically significant impairment was defined as parent-rated Behavior Rating Inventory of EF (BRIEF) Global Executive Composite (GEC) t scores ≥65.

L-methylfolate Plus SSRI or SNRI from Treatment Initiation Compared to SSRI or SNRI Monotherapy in a Major Depressive Episode.

Objective: Evaluate the efficacy of L-methylfolate in combination with SSRI or SNRI compared to SSRI or SNRI monotherapy in a major depressive episode.

Design: A retrospective analysis of L-methylfolate plus SSRI/SNRI at treatment initiation (n=95) and SSRI/SNRI monotherapy (n=147) from patient charts.

Setting: Outpatient, private psychiatric clinic/practice.

Impact of drug tolerability on the selection of antidepressant treatment in patients with major depressive disorder.

Despite significant progress in the development of antidepressant therapies, tolerability remains an important factor associated with the selection of appropriate antidepressant treatment. Side effects commonly reported by depressed patients taking antidepressants include weight gain, sexual dysfunction, and gastrointestinal effects.Tolerability issues associated with antidepressants can negatively impact treatment outcomes for patients with major depressive disorder.

Effectiveness, safety, and tolerability of lisdexamfetamine dimesylate in children with attention-deficit/hyperactivity disorder: an open-label, dose-optimization study.

Objective: The aim of this study was to assess the effectiveness and safety of lisdexamfetamine dimesylate (LDX) in children with attention-deficit/hyperactivity disorder (ADHD).

Method: This was a 7-week, open-label study evaluating 20, 30, 40, 50, 60, or 70 mg/day LDX in 318 children aged 6-12 years with ADHD. The ADHD Rating Scale IV (ADHD-RS-IV) was the primary efficacy assessment.

Safety and effectiveness of coadministration of guanfacine extended release and psychostimulants in children and adolescents with attention-deficit/hyperactivity disorder.

Objective: The aim of this study was to evaluate the safety and effectiveness of guanfacine extended release (GXR) administered concomitantly with psychostimulants in children and adolescents with attention-deficit/hyperactivity disorder (ADHD) and suboptimal response to a psychostimulant alone.

Design And Methods: This was a multicenter, open-label, 9-week, dose-escalation study of 75 subjects with ADHD treated with methylphenidate (MPH) or amphetamine (AMP) alone for at least 1 month, yet with suboptimal control of ADHD symptoms. Sixty-three subjects (84.

Effect of lisdexamfetamine dimesylate on parent-rated measures in children aged 6 to 12 years with attention-deficit/hyperactivity disorder: a secondary analysis.

Unlabelled: To evaluate the efficacy of lisdexamfetamine dimesylate (LDX) in school-aged children with attention-deficit/hyperactivity disorder (ADHD), using the Conners' Parent Rating Scale, Revised Short Version (CPRS-R:S) and its subscales.

Methods: This was a secondary post hoc analysis of data from a placebo-controlled, double-blind, parallel-group, forced dose-escalation trial. Boys and girls aged 6 to 12 years with a primary diagnosis of ADHD were randomly assigned to LDX (30, 50, or 70 mg/d) or placebo.

Bipolar II disorder: current and future treatment options.

Background: Bipolar II (BPII) disorder is a significant public health problem in the United States, and there is a dearth of studies of effective treatment modalities to deal with the recurrent major depressive episodes that accompany the disorder. This review attempts to summarize available data on agents useful in treating patients with the disease.

Methods: English language controlled clinical trials involving BPII patients obtained from an extensive Medline search were critically reviewed.

A retrospective analysis of changing from alternative agents to carbamazepine extended-release capsules in bipolar disorder.

Background: Patients with bipolar disorder do not respond to the same therapy in the same way. This potentially necessitates the trial of various treatment modalities in a patient until the illness can be successfully controlled.

Methods: Medical histories from 187 patients were reviewed to obtain information on efficacy when patients were switched from their initial drug therapy-immediate-release (IR) or extended-release (ER) carbamazepine (CBZ) tablets, valproic acid, lamotrigine, lithium, olanzapine, and oxcarbazepine-to beaded CBZ extended-release capsules (CBZ-ERC) (Shire, Wayne, PA, USA).

Safety and efficacy of carbamazepine extended-release capsules in patients with bipolar disorder: QD vs BID.

Background: Adherence to prescribed pharmacotherapy is an important factor in the success of a selected treatment regimen. Because the dosing frequency of a particular medication can affect adherence rates, this important aspect of treatment must be taken into account. This report presents results from a retrospective assessment of the charts of 23 patients who received once-daily (qd) carbamazepine extended-release capsules (CBZ-ERC) (Shire, Wayne, PA, USA) for the treatment of bipolar disorder.

Predictors of response to carbamazepine extended-release capsules treatment in bipolar disorder.

Background: Predictors of response to psychoactive drugs are valuable in providing practical guidance and in optimizing a treatment regimen. Here we used linear regression analysis to identify treatment-specific predictors of response to therapy with beaded extended-release carbamazepine capsules (CBZ-ERC) (Shire, Wayne, PA, USA) in 600 outpatients with bipolar disorder.

Methods: Data were obtained from medical charts of subjects who received CBZ-ERC in a private practice setting.

Safety of carbamazepine extended-release capsules in bipolar disorder polypharmacy.

Background: This analysis is a retrospective chart review evaluating the safety of carbamazepine (CBZ) extended-release capsules (CBZ-ERC) (Shire, Wayne, PA, USA) when used in combination with other agents as part of a polypharmacy regimen in the treatment of patients with bipolar disorder. The safety of CBZ-ERC was determined by comparing the adverse event profiles of patients on monotherapy versus those of patients on polytherapy.

Methods: The medical records of 300 adult patients (aged 18-70) treated in a private practice setting with CBZ (monotherapy or polytherapy) who met the DSM-IV criteria for bipolar disorder were examined.

Outcomes and length of treatment with carbamazepine extended-release capsules in bipolar disorder.

Background: This analysis was a retrospective chart review evaluating the relationship between outcomes and length of treatment with carbamazepine extended-release capsules (CBZ-ERC) (Shire, Wayne, PA, USA) in bipolar disorder.

Methods: The medical records of adult patients (>or=18 years) meeting DSM-IV criteria for bipolar disorder who were treated with CBZ-ERC for 30 days or less, 31 to 180 days, and more than 180 days were reviewed in this study.

Results: There were significant differences in mean Clinical Global Impression-Improvement (CGI-I) scores at the best office visit among the three treatment groups.

Carbamazepine extended-release capsules use in bipolar disorder: efficacy and safety in adult patients.

Background: Safety, tolerability, and efficacy of carbamazepine (CBZ) have been demonstrated in numerous studies over the last three decades. Until recently, CBZ studies largely involved immediate-release formulations, while long-term studies have been few in number. The recent development of beaded CBZ extended-release capsules (CBZ-ERC) (Shire, Wayne, PA, USA) provides a new formulation with potential advantages in safety, tolerability, and efficacy over earlier formulations.

Carbamazepine extended-release capsules: a retrospective review of its use in children and adolescents.

Background: Bipolar disorder occurs in 1% of children and adolescents, but few clinical trials address treatment of this population. This retrospective chart review evaluated the long-term safety and tolerability of carbamazepine extended-release capsules (CBZ-ERC) (Shire, Wayne, PA, USA) in 300 children and adolescent patients who had been treated for bipolar disorder in a private psychiatric practice.

Methods: Data were collected from the medical records of all young and adolescent (4-17 years old) patients who met the DSM-IV criteria for a diagnosis of bipolar disorder type I, type II, or bipolar not otherwise specified who had been treated with CBZ-ERC either as add-on or monotherapy between October 1998 and November 2003 at Red Oak Psychiatry Associates, Houston, TX.

Efficacy and safety of lamotrigine for adults with bipolar disorder in a private practice setting.

Introduction: Lamotrigine is approved by the Food and Drug Administration for maintenance therapy in patients with bipolar I disorder. However, several studies of acute-phase and maintenance treatment support the efficacy of lamotrigine for bipolar I and bipolar II disorders. This chart review was performed to assess the efficacy and safety of lamotrigine in the treatment of bipolar disorder in a private psychiatric practice setting and to investigate differences in response among patients with different diagnostic subtypes of bipolar disorder.

Effect of lamotrigine on cognitive complaints in patients with bipolar I disorder.

Background: This analysis describes the effects of bipolar I disorder on self-reported neurocognitive measures and remediation of these deficits with lamotrigine therapy.

Method: Data were derived from 2 clinical trials designed to assess the efficacy of lamotrigine as maintenance therapy for recently manic (N = 349) or depressed (N = 966) patients (DSM-IV criteria). During the 8- to 16-week open stabilization phase, patients received lamotrigine as monotherapy or as adjunctive therapy (target dose = 200 mg/day, minimum dose = 100 mg/day) while other psychotropic drugs were discontinued.

Safety and tolerability of lamotrigine for bipolar disorder.

Tolerability and safety are important considerations in optimising pharmacotherapy for bipolar disorder. This paper reviews the tolerability and safety of lamotrigine, an anticonvulsant recommended in the 2002 American Psychiatric Association guidelines as a first-line treatment for acute depression in bipolar disorder and one of several options for maintenance therapy. This paper reviews the tolerability and safety of lamotrigine using data available from a large programme of eight placebo-controlled clinical trials of lamotrigine enrolling a total of nearly 1800 patients with bipolar disorder.

GW320659 for the treatment of attention-deficit/hyperactivity disorder in children.

Objective: To assess the safety, tolerability, and efficacy of GW320659, a chemically novel inhibitor of norepinephrine and dopamine reuptake, in pediatric attention-deficit/hyperactivity disorder (ADHD).

Method: This was a multicenter, open-label, dose-titration study of seven daily dose levels of GW320659: 1.25, 2.