Notes

Albuminuria Is Associated with Hepatic Iron Insert inside Patients along with Non-Alcoholic Fatty Hard working liver Disease along with Metabolic Affliction.
Supporting the potential use of OLZ/SAM in BD-I, OLZ/SAM or olanzapine resulted in bioequivalent olanzapine plasma concentrations, and OLZ/SAM did not affect lithium or valproate pharmacokinetics. OLZ/SAM treatment had no clinically relevant effects on ECG parameters (including QTc interval). OLZ/SAM and olanzapine safety were similar, except for reduced weight gain with OLZ/SAM; no additional safety risks were identified.

Data across 18 OLZ/SAM studies in >1600 subjects support an antipsychotic efficacy and safety profile for OLZ/SAM that is similar to olanzapine, with significantly less weight gain than olanzapine. OLZ/SAM is a potential new treatment for schizophrenia and BD-I patients needing efficacious long-term treatment with reduced risk of weight gain.

Alkermes, Inc.
Alkermes, Inc.
Approved treatments for bipolar depression are limited and associated with a spectrum of undesirable side effects. Lumateperone (lumateperone tosylate, ITI-007), a mechanistically novel antipsychotic that simultaneously modulates serotonin, dopamine, and glutamate neurotransmission, is FDA-approved for the treatment of schizophrenia. Lumateperone is currently being investigated for the treatment of bipolar depression (major depressive episodes [MDE] associated with bipolar I and bipolar II disorder). This Phase 3 randomized, double-blind, parallel-group, placebo-controlled multinational study (NCT03249376) investigated the efficacy and safety of lumateperone in patients with bipolar I or bipolar II disorder experiencing a MDE.

Patients (18 75 years) with a clinical diagnosis of bipolar I or bipolar II disorder who were experiencing a MDE (Montgomery-Åsberg Depression Rating Scale [MADRS] Total score =20 and a Clinical Global Impression Scale-Bipolar Version-Severity [CGI-BP-S] score =4 at screening and ba1.99; ES=-0.49; P<.0001) and bipolar II (LSMD=-7.0; 95% CI=-10.92, -3.16; ES=-0.81; P=.0004). The lumateperone 42-mg group also had significantly greater mean improvement in CGI-BP-S total score compared with placebo (LSMD=-0.9; 95% CI=-1.37, -0.51; ES=-0.46; P<.001). Lumateperone compared with placebo had significantly greater MADRS response rate (51.1% vs 36.7%; odds ratio=2.98; P<.001) and remission rates (P=.02) at Day 43. Lumateperone treatment was well tolerated, with minimal risk of EPS, metabolic, and prolactin side effects.

Lumateperone 42 mg significantly improved depression symptoms in both patients with bipolar I and bipolar II depression. Lumateperone was generally well tolerated. These results suggest that lumateperone 42 mg may be a promising new treatment for bipolar depression associated with bipolar I or bipolar II disorder.

Intra-Cellular Therapies, Inc.
Intra-Cellular Therapies, Inc.
Serotonin syndrome is a potentially life-threatening condition associated with increased serotonergic activity in the central nervous system. Serotonin syndrome is underreported complication of pharmacotherapy. The Hunter Criteria for serotonin syndrome (SS) are fulfilled if the patient has taken a serotonergic agent and has one of the following symptoms 1) spontaneous clonus, 2) inducible clonus and agitation or diaphoresis, 3) ocular clonus and agitation or diaphoresis, 4) tremor and hyperreflexia, 5) hypertonia, or 6) temperature above 38 C and ocular clonus or inducible clonus.

Patient A was a 16-year-old Caucasian male with history of major depressive disorder, social anxiety and OCD who presented to the emergency room with multiple complaints twitching of bilateral cheeks, intermittent tremor of his hands and feet, mental fogginess/confusion, stuttering when attempting to speak, agitation, profuse sweating and headache. 3 weeks prior, his sertraline dose was increased from 25mg daily to 50 mg daily.rotonin syndrome. It is also vital to educate parents and caregivers about the toxicities of SSRIs, including serotonin syndrome, so they may monitor treatment and take appropriate action if needed.
The main objectives of this case study are 1. Clinicians facing symptoms that are difficult to interpret should exercise caution in diagnosing conversion disorder. 2. Increasing awareness about rare neurological conditions may appear as psychogenic illnesses. 3. Clinicians be advocate for their patients.

Conversion disorder is a mental condition in which a person present with one or more symptoms of altered voluntary motor or sensory function, or other neurologic symptoms that cannot be explained by medical evaluation. Stiff person syndrome (SPS) is a disabling autoimmune central nervous system disorder characterized by progressive muscle rigidity, gait impairment, with superimposed painful spasms. SPS is commonly associated with high anti-glutamic acid decarboxylase (GAD) antibody titers. The dominant antigen recognized by these antibodies is the GABA-synthesizing enzyme GAD.

Patient X, a 17-year-old Hispanic American female who presented to the Child and Adolescent Psychiatry Clinic with the complainton disorder. A systematic review of 27 studies found that among 1466 patients initially diagnosed with conversion symptoms, the frequency of misdiagnosis was approximately 4 percent.References. BMJ. Selleck Bcl2 inhibitor 2005;331(7523)989. Epub Oct 13. Childhood onset of stiff-man syndrome. JAMA Neurol. 2013;70(12)1531. J Neurol Neurosurg Psychiatry. 2015 Aug; 86(8)840-8. Epub 2014 Dec 15.
Objectives for this survey are to determine similarities or differences in treatment goals reported by psychiatrists, patients with schizophrenia (SCZ) and caregivers in the US, as well as whether goals differed by patients currently on an oral antipsychotic (OAP) or long-acting injectable (LAI), and whether goals differed by age.

This was a real-world, cross-sectional survey of US psychiatrists, patients =18 years old diagnosed with SCZ, and caregivers. Data was collected using the Disease Specific Programme (DSP) methodology. Psychiatrists (n=120) completed detailed record forms for next 8 outpatients and 2 inpatients matching inclusion criteria. The same patients and their caregivers, if present, were invited by their psychiatrist to voluntarily complete a separate survey.

Responses on treatment goals were collected from psychiatrists for all patients included in the analysis (n=1161), patients (n= 542) and caregivers (n=130). Among 3 top goals, psychiatrists, patients and caregivers concurred that " Commercialization, Inc.
SEP-363856 is a novel psychotropic agent without dopamine D2 receptor occupancy. Although its mechanism of action has not been fully elucidated, preclinical data suggest that agonism at trace amine receptor 1 (TAAR1) and the serotonin 5-H1A receptor contributes to its efficacy. In a double-blind (DB), placebo-controlled study, SEP-363856 demonstrated significant efficacy in the treatment of an exacerbation of schizophrenia (Koblan et al, NEJM 2020; 821497-1506). We present results of a 6-month extension study whose aim was to evaluate the safety and effectiveness of longer-term treatment with SEP-363856.

Patients with an acute exacerbation of schizophrenia who completed a 4-week, DB, placebo-controlled, flexible-dose (50 or 75 mg) study of SEP-363856 were given the option to enroll in an extension study in which they were treated, open-label (OL), with flexible doses (25/50/75 mg/d) of SEP-363856 for 26-weeks. The primary outcomes were safety measures; effectiveness outcomes were secondary and included th6 change from DB baseline in weight was -0.3 kg. No clinically meaningful median changes were observed at week 26 in metabolic laboratory parameters (total and LDL cholesterol, triglycerides, hemoglobin A1c) or in prolactin levels. During 6 months of OL treatment, one patient had an increase in QTcF =60 msec; no patients had a QTcF interval =480 msec. Treatment with SEP-363856 was associated with significant improvement from OL baseline to week 26 in PANSS total score (-22.6) and BNSS total score (-11.3).

Treatment with SEP-363856 was associated with continued improvement from open-label baseline in the PANSS total (-22.6) and BNSS total (-11.3) scores. The most frequently reported adverse events (= 5%) were schizophrenia, headache, insomnia and anxiety. SEP-363856 had minimal effects on weight, lipids, glycemic indices, prolactin, and was associated with minimal risk of extrapyramidal symptom.

Sunovion Pharmaceuticals Inc.
Sunovion Pharmaceuticals Inc.
There are no established treatment guidelines for tardive dyskinesia (TD) based on movement severity. The 12-week ARM-TD and AIM-TD studies in TD patients with baseline Abnormal Involuntary Movement Scale (AIMS) total score (items 1-7) ≥6 showed clinically significant improvements in AIMS score with deutetrabenazine versus placebo. Patients who completed these studies were eligible for the open-label extension (OLE) trial. This post-hoc analysis evaluated deutetrabenazine in TD patients with severe movements.

Subgroups were defined by upper quartile of baseline total AIMS score (local rating). Endpoints were change and percent change from baseline in AIMS score, and percent of patients achieving ≥50% AIMS reduction from baseline.

337 patients were analyzed. The upper quartile of baseline total AIMS score was 14. Subgroups were defined as >14 and ≤14 at baseline, respectively (n=64 vs 273); data are presented at Week 145 (n=40 vs 120). Mean treatment duration was 880.5 and 760.8 days. Mean±SE daily doses were 41.1±1.6mg and 38.9±1.0mg. Mean±SE change from baseline in AIMS score was -11.0±0.8 versus -5.1±0.3; percent change from baseline was -60.1%±3.6% versus -55.9%±3.0%. More patients with AIMS score >14 had ≥50% AIMS reduction (73% vs 65%). Less patients discontinued (38% vs 51%); reasons included withdrawal by subject (16% vs 25%), adverse event (3% vs 11%), and lost to follow-up (6% vs 7%). Withdrawal due to lack of efficacy was uncommon (5% vs 2%).

Patients with baseline total AIMS score >14 had clinically meaningful reductions in AIMS score, suggesting deutetrabenazine has long-term benefit in these patients.

Teva Pharmaceutical Industries Ltd., Petach Tikva, Israel.
Teva Pharmaceutical Industries Ltd., Petach Tikva, Israel.
Disease prevalence, comorbid conditions, and pharmacological treatments were examined in a large population of US commercial- or Medicaid-insured individuals with schizophrenia.

This retrospective, cross-sectional claims analysis sourced data from the IBM MarketScan Commercial and Medicare Supplemental Databases and the Multi-state Medicaid Database (01Jan2009 to 30Jun2016). Cases were defined by =1 diagnostic claim (ICD-9-CM/ICD-10-CM) for schizophrenia during the study period. Comorbidities (=1 ICD-9-CM/ICD-10-CM diagnosis code) were grouped according to Clinical Classifications Software (CCS) level 2 categories. For the per-database analysis of comorbidities, schizophrenia cases were matched with controls by demographic characteristics. Case-control comorbidity comparisons were performed using prevalence rate ratios (PRRs) and 95% CIs. Per-database medication exposure (=1 National Drug Code in outpatients grouped by Redbook classification) was also assessed.

Schizophrenia prevalence was 0.11% and 0.9kermes, Inc.
Drug-induced movement disorders (DIMDs) may occur in patients treated with antipsychotics. The CommonGround Program supports the recovery and healing of psychiatric outpatients through tools which facilitate better patient-doctor communication regarding psychiatric symptoms, DIMDs, and the effectiveness of treatment.

Patients responses to CommonGround's web-based waiting-room questionnaire were analyzed in patients who responded yes to having concerns about developing DIMDs (MD-YES) and those who responded no to this question (MD-NO). These groups were compared descriptively to assess the potential effects of DIMD concerns on self-reported functioning and beliefs about prescribed psychiatric medications.

Of 7874 responding patients, 312 (4.0%) and 7562 (96.0%) were in the MD-YES and MD-NO subgroups, respectively. A higher percentage of MD-YES patients reported poor / not so good ability to keep up with daily responsibilities (21.2% vs 15.2% vs MD-NO), along with low energy levels (37.1% vs 26.3% for MD-NO), bothersome thoughts/beliefs/fears (30.
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