Phase 2, randomized dose-finding study of tapinarof (GSK2894512 cream) for the treatment of plaque psoriasis.

Background: There is a significant need for novel, safe, and efficacious topical treatments for psoriasis.

Objective: We assessed the safety and efficacy of tapinarof in a new cream formulation at 2 concentrations and with 2 application frequencies in adults with psoriasis.

Methods: Double-blind, vehicle-controlled, randomized, 6-arm trial (1:1:1:1:1:1) in adults, with psoriasis with body surface involvement ≥1% and ≤15% and Physician Global Assessment (PGA) score ≥2 at baseline.

A phase 2, randomized dose-finding study of tapinarof (GSK2894512 cream) for the treatment of atopic dermatitis.

Background: Safe and efficacious topical treatments are needed for atopic dermatitis (AD).

Objective: We assessed the safety and efficacy of tapinarof cream (2 concentrations and 2 application frequencies) in patients with AD.

Methods: A double-blind, vehicle-controlled, randomized, 6-arm trial (1:1:1:1:1:1) in patients age 12 to 65 years, with body surface area involvement of at least 5% to 35% and an Investigator's Global Assessment score of 3 or higher (moderate to severe) at baseline.

A randomized placebo-controlled phase 3 trial of an antisense oligonucleotide, drisapersen, in Duchenne muscular dystrophy.

This 48-week, randomized, placebo-controlled phase 3 study (DMD114044; NCT01254019) evaluated efficacy and safety of subcutaneous drisapersen 6 mg/kg/week in 186 ambulant boys aged ≥5 years, with Duchenne muscular dystrophy (DMD) resulting from an exon 51 skipping amenable mutation. Drisapersen was generally well tolerated, with injection-site reactions and renal events as most commonly reported adverse events. A nonsignificant treatment difference (P = 0.

Adjunctive Maintenance Lamotrigine for Pediatric Bipolar I Disorder: A Placebo-Controlled, Randomized Withdrawal Study.

Objective: This study aimed to compare the efficacy of lamotrigine versus placebo in 10- to 17-year-olds with bipolar I disorder (BP-I) who were receiving conventional bipolar disorder treatment.

Method: In this randomized withdrawal trial, patients with BP-I of at least moderate severity received lamotrigine during an ≤18-week open-label phase. Patients who maintained a stable lamotrigine dose for ≥2 weeks and Clinical Global Impression-Bipolar Severity of Illness (CGI-BP[S]) score of ≤3 for ≥6 consecutive weeks were randomized to double-blind lamotrigine or placebo for ≤36 weeks.

Safety and efficacy of drisapersen for the treatment of Duchenne muscular dystrophy (DEMAND II): an exploratory, randomised, placebo-controlled phase 2 study.

Background: Duchenne muscular dystrophy is caused by dystrophin deficiency and muscle deterioration and preferentially affects boys. Antisense-oligonucleotide-induced exon skipping allows synthesis of partially functional dystrophin. We investigated the efficacy and safety of drisapersen, a 2'-O-methyl-phosphorothioate antisense oligonucleotide, given for 48 weeks.

Pharmacokinetics and safety of single doses of drisapersen in non-ambulant subjects with Duchenne muscular dystrophy: results of a double-blind randomized clinical trial.

Duchenne muscular dystrophy (DMD) is a progressive, lethal neuromuscular disorder caused by the absence of dystrophin protein due to mutations of the dystrophin gene. Drisapersen is a 2'-O-methyl-phosphorothioate oligonucleotide designed to skip exon 51 in dystrophin pre-mRNA to restore the reading frame of the mRNA. This study assessed safety, tolerability, and pharmacokinetics of drisapersen after a single subcutaneous administration in non-ambulatory subjects.

Multimodal study of secondary interactions in Cp*Ir complexes of imidazolylphosphines bearing an NH group.

Hydrogen bonding phenomena are explored using a combination of X-ray diffraction, NMR and IR spectroscopy, and DFT calculations. Three imidazolylphosphines R(2)PImH (ImH = imidazol-2-yl, R = t-butyl, i-propyl, phenyl, 1a-1c) and control phosphine (i-Pr)(2)PhP (1d) lacking an imidazole were used to make a series of complexes of the form Cp*Ir(L(1))(L(2))(phosphine). In addition, in order to suppress intermolecular interactions with either imidazole nitrogen, 1e, a di(isopropyl)imidazolyl analogue of 1b was made along with its doubly (15)N-labeled isotopomer to explore bonding interactions at each imidazole nitrogen.

Differences in medication adherence and healthcare resource utilization patterns: older versus newer antidepressant agents in patients with depression and/or anxiety disorders.

Background: Given the number of antidepressants available and their rising costs, healthcare payers have initiated restrictive reimbursement policies for newer antidepressants, without consideration for differences in their effectiveness or tolerability.

Objective: The objective of this study was to comprehensively compare medication adherence rates and associated healthcare utilization costs for patients using later-generation versus earlier-generation antidepressants in a managed care setting. Antidepressants launched after 2002 were deemed third-generation antidepressants, while antidepressants available prior to 2002 were deemed first-generation (TCAs and MAOIs) and second-generation (serotonin and noradrenaline [norepinephrine]-dopamine reuptake inhibitors).

Managing treatment resistant violent adolescents: a step forward by substituting seclusion for mechanical restraint?

Despite a growing consensus that seclusion or restraint should never be used with children or adolescents, there are a few patients who are resistant to treatment, and are persistently violent. The purpose of this study was to measure the efficacy of installing a padded seclusion room to decrease the use of mechanical restraints, a potentially more emotionally traumatic and dangerous intervention than seclusion. After padded room installation, the number of monthly mechanical restraint events per 1000 patient days decreased by 93.

Olanzapine versus risperidone in newly admitted acutely ill psychotic patients.

Objective: Risperidone and olanzapine are the 2 most widely prescribed second-generation anti-psychotics. The purpose of this study was to compare the efficacy of risperidone and olanzapine using duration of hospitalization as the primary outcome measure. This outcome was selected as it is an indirect measure of how well patients are responding to the medication and represents a "real world" endpoint relevant to practicing hospital psychiatrists.

Implementing a smoking ban in an acute psychiatric admissions unit.

In contrast to general medical hospitals, psychiatric hospitals often allow patients to smoke cigarettes. In addition to obvious health concerns, smoking can also interfere with clinical assessments and therapeutic activities, Implementation of a smoking ban on an acute male admissions unit did not result in any increase in aggressive behaviors. In addition, staff attitudes following the ban improved, and most staff members believed the ban was both ethical and beneficial to patients.

Clozapine reduces violent behavior in heterogeneous diagnostic groups.

Violent behavior is a significant problem in the psychiatric hospital setting. Persistently violent patients often require seclusion and/or restraints and typically receive high doses of medication and polypharmacy. Clozapine has been found to be effective in reducing aggression in patients with psychosis.

Neurosyphilis in newly admitted psychiatric patients: three case reports.

Background: Neurosyphilis, also known as "general paresis of the insane," at one time accounted for a large portion of admissions to state psychiatric facilities. With the introduction of antibiotics, neurosyphilis is now considered very rare.

Method: Chart review was performed on patients diagnosed with neurosyphilis who were admitted to a state psychiatric hospital in Raleigh, N.

Characteristics of violent behavior in a large state psychiatric hospital.

Violent behavior is a significant problem in psychiatric hospitals. The authors reviewed hospital incident reports to identify the characteristics of violent behavior in a large state psychiatric hospital. They found that a very small percentage of patients accounted for a majority of violent episodes, that rates of violent behavior varied among hospital units, that assaultive behavior was more common than self-harm in the long-term units, and that most commonly the assault victims were other patients.

Effects of topiramate on aggressive, self-injurious, and disruptive/destructive behaviors in the intellectually disabled: an open-label retrospective study.

This study reviews the treatment response to the antiepileptic drug topiramate (Topamax-mean dose 202 mg/d, range 150-350 mg/d) of a group of 22 institutionalized intellectually disabled adults (8 males, 14 females, mean age 46.5 years, age range 25-70 years). These individuals were predominantly classified as having severe or profound intellectual disability and as having a mood disorder.