Notes

Endoscopic resection of the duodenal neuroendocrine growth.
265 patients received OLZ/SAM; 167 (63.0%) completed the extension study. Common AEs (= 5%) were weight decreased (n=23; 8.7%), extra dose administered (n=21; 7.9%), headache (n=18; 6.8%), and weight increased (n=16; 6.0%). At week 52, mean (SD) change from baseline for weight and waist circumference was -0.03 (6.216) kg and -0.35 (6.115) cm, respectively. Changes in fasting lipid and glycemic parameters were generally small and remained stable over 52 weeks. PANSS total scores remained stable during the extension.

OLZ/SAM was generally well tolerated over 52 weeks. Weight, waist circumference, metabolic laboratory parameters, and schizophrenia symptoms remained stable throughout the study.

Alkermes, Inc.
Alkermes, Inc.
Bipolar disorder frequently has an early onset, with an estimated 1.8% prevalence of bipolar I disorder in children and adolescents. Childhood onset of bipolar disorder is typically associated with a chronic, severe, and disabling course of illness. Relatively few prospective studies are available that evaluate the long-term efficacy of atypical antipsychotics in achieving and sustaining response or remission in pediatric patients with bipolar depression. Lurasidone has been approved by the FDA as monotherapy for bipolar depression in pediatric patients ages 10-17 years. The aim of the current post-hoc analysis was to evaluate the long-term efficacy of lurasidone in achieving response or remission in children and adolescents with bipolar depression followed over a two-year period.

Patients 10-17 years with bipolar I depression who completed a 6-week double-blind (DB) study of lurasidone vs. placebo were eligible to enroll in a two-year, open-label (OL) extension study in which patients were continued on fxtension study; 195 (63.7%) patients completed one year of treatment and 168 (54.9%) patients completed two years of treatment. Selleckchem Finerenone Responder rates at OL baseline, one year, and two years were 51.0%, 88.4% and 91.1%, respectively; remission rates were 24.3%, 61.3%, and 75.6%, respectively; and recovery rates were 17.7%, 53.8%, and 73.8%. On a Pearson correlation analysis, there was a strong inverse relationship (r = -0.71) between CDRS-R total score, and global functioning as measured by the CGAS. Sustained remission was achieved by 37.2% of patients at one year and 57% of patients after two years.

In children and adolescents with bipolar depression, up to 2 years of treatment with lurasidone was associated with continued improvement in depressive symptoms, resulting in progressively higher rates of response, remission, recovery, and the more rigorously calculated outcome of sustained remission.

Sunovion Pharmaceuticals Inc.
Sunovion Pharmaceuticals Inc.
Deutetrabenazine, a novel vesicular monoamine transporter 2 (VMAT2) inhibitor, is approved by the FDA for treatment of tardive dyskinesia (TD) in adults. Dopamine-receptor antagonists (DRAs) are associated with worsening of metabolic parameters, including weight gain, hyperlipidemia, and elevated blood glucose. This post hoc analysis assessed the short- and long-term effects of deutetrabenazine treatment on weight and metabolic parameters in individuals treated for TD.

Two 12-week, randomized placebo-controlled trials (RCTs) of deutetrabenazine for patients with TD evaluated either fixed dosing (AIM-TD; 12, 24, or 36 mg) or dose titration (ARM-TD; max dose, 48 mg/day). Patients completing ARM-TD or AIM-TD were included in an open-label extension (OLE) study, in which all patients underwent response-driven titration of deutetrabenazine from 12 mg/day up to a maximum total dose of 48 mg/day. Weight, body mass index (BMI), serum glucose, serum total cholesterol, and serum triglycerides were evaluated at base.
Teva Pharmaceutical Industries Ltd., Petach Tikva, Israel.
The population of patients with major depressive disorder (MDD) and suicidal ideation (SI) or behaviors/attempts (SA) is not well characterized. Electronic health records (EHR) may contain useful data elements that are unavailable in other routinely used population-level databases like insurance claims. For example, the Patient Health Questionnaire (PHQ)-9 is a disease severity metric in this population which may influence treatment choices and hence, outcomes. This study sought to describe the treatments, depression severity, and health resource utilization among this population prior to, during, and following a suicide-related event.

Adult patients enrolled in an integrated delivery network with a diagnosis code indicating MDD and without a diagnosis for bipolar or related disorders, dementia, intellectual disability, schizophrenia or other non-mood psychotic disorders between 10/31/2015 and 9/30/2019 were selected from the Optum de-identified EHR database. Only patients with a diagnosis code for SI or espectively. During follow-up, the percent with ≥1 all-cause (MDD-related) hospitalization, observation stay and ED visit were 11.8% (7.0%), 5.0% (2.1%), and 33.1% (11.1%). More than half (61.0) had ≥1 outpatient visit, and about 1/3 (33.4%) had ≥1 MDD-related outpatient visit. Very few patients had PHQ-9 scores recorded pre-period 4.4% (mean [SD] 13.0 [7.5]); index period 1.3% (mean [SD] 17.0 [7.2]); and follow-up period 7.6% (mean [SD] 12.1 [7.5]).

This study documents a high level of health care resource utilization among those with MDD and suicidal thoughts and behaviors. Only a small proportion had documented PHQ-9 scores. Given that sizable proportions did not receive any antidepressant therapy or psychotherapy, even after suicidality was noted in their medical record, continued efforts in screening and treatment intensification are warranted for this vulnerable population.

Janssen Scientific Affairs, LLC.
Janssen Scientific Affairs, LLC.
Psychiatric prescribers typically assess adherence by patient or caregiver self-report. A new digital medicine (DM) technology provides objective data on adherence by using an ingestible event monitoring (IEM) sensor embedded within oral medication to track ingestion. Despite likely clinical benefit, adoption by prescribers will in part depend on attitudes toward and experience with digital health technology, learning style preference (LSP), and how the technology s utility and value are described.

is to identify attitudes, experiences, and proclivities toward DM platforms that may affect adoption of the IEM platform and provide direction on tailoring educational materials to maximize adoption. Methods A survey of prescribers treating seriously mentally ill patients was conducted to assess drivers/barriers to IEM adoption. Factor analysis was performed on 13 items representing prior experience with and attitudes toward DM. Factor scores were correlated with prescriber characteristics including attitude and experience with digital technologies, LSP, and level of focus on healthcare cost.
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