Alkermes Expands Planned New Drug Application for ALKS 3831 to Include Treatment of Bipolar I Disorder

Following Pre-NDA Meeting With FDA, Company Plans to Submit New Drug Application for Schizophrenia and Bipolar I Disorder Indications in the Fourth Quarter of 2019 DUBLIN, July 15, 2019 -- (Healthcare Sales &Marketing Network) -- Alkermes plc (Nasdaq:... Biopharmaceuticals, FDA Alkermes, ALKS 3831, olanzapine, samidorphan
Source: HSMN NewsFeed - Category: Pharmaceuticals Source Type: news

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Did the movie Joker portray mental illness correctly and does it matter? We passionately go over the movie Joker from the lense of people living with mental illness and discuss whether or not there are implications of making a movie like this. Does it help us or hurt us? What if it does both? Listen in to hear Gabe’s freakishly good recollection of scenes from the movie as Jackie struggles to separate entertainment from reality.  Spoiler Alert: You don’t need to see Joker to appreciate this conversation but we do go over the plot and reveal some important scenes from the movie. (Transcript Available Below)...
Source: World of Psychology - Category: Psychiatry & Psychology Authors: Tags: A Bipolar, A Schizophrenic, and a Podcast Antidepressant Antipsychotic Depression Minding the Media Not Crazy Podcast Source Type: blogs
We examined the concentrations of chemokines and related substances in the brain tissue from these two groups using the Bio-Plex Pro™ Human Chemokine Panel 40-Plex. We performed multiple regression analysis with covariates. The levels of CCL1, CCL8, CCL13, CCL15, CCL17, CCL19, CCL20, CXCL11, and IL-10 were significantly decreased, whereas the IL-16 levels were significantly increased in the suicide completers after adjustment with the Benjamini-Hochberg method to control for type Ⅰ errors (Q 
Source: Journal of Psychiatric Research - Category: Psychiatry Source Type: research
This study determines the relationship between cognition and vascular burden in patients with SMD. Methods: Sixty SMD patients (61% men, mean age: 46) attending a psychosocial rehabilitation centre were included. We evaluated sociodemographic, clinical, laboratory, quality of life and functionality characteristics. And we analysed the association between cognitive performance and vascular burden. Results: SMD diagnoses were: 41.7% schizophrenia, 20.0% bipolar, 5.0% schizoaffective, 21.7% depressive and 11.7% other. Cognitive impairment was present in 55% of the cases. The average vascular burden was 3.2. Patients with cogn...
Source: Cognitive Neuropsychiatry - Category: Psychiatry Tags: Cogn Neuropsychiatry Source Type: research
ConclusionThis case highlights the importance of maintaining a high index of suspicion when encountering psychiatric patients with nonspecific lower abdominal or anorectal pain with inconsistent presentations. Controversy exists regarding the type of surgical treatment in case of anorectal perforation. More research is needed to provide surgeons with evidence-based standardized methods for dealing with these rare pathologies.
Source: Annals of Medicine and Surgery - Category: General Medicine Source Type: research
This article suggests that systems biology, emphasizing the epigenetic component of systems biology, could help identify clinically useful biomarkers in neuropsychiatric disorders like SZ, BD, and MDD.
Source: Frontiers in Genetics - Category: Genetics & Stem Cells Source Type: research
In this study we aimed to evaluate the pleiotropic nature of SLC6A4 alterations and their association with the overall risk of brain diseases rather than disorder-specific. SLC6A4 variants, namely 5HTTLPR, STin2, rs2066713, rs25531, rs4251417, rs6354 and rs7224199 were investigated in 4 independent cohorts of subjects with specific psychiatric disorders, including Alcohol dependence disorder (ALC), Alzheimer disease (ALZ), Schizophrenia (SCZ) and Bipolar disorder (BPD). Other variables (biochemical parameters and Psychiatric scales scores) were also tested for association. SLC6A4 polymorphisms are not associated with the r...
Source: Molecular Biology Reports - Category: Molecular Biology Authors: Tags: Mol Biol Rep Source Type: research
AbstractOlanzapine, a second ‐generation atypical antipsychotic drug, is widely used for schizophrenia and moderate to severe mania associated with bipolar disorders. This open‐label, randomized, single‐dose, 2‐sequence, 2‐period crossover, comparative pharmacokinetic study assessed the bioequivalence of 5 mg of olan zapine administered in tablet (R) or disintegrating tablet (T) formulation in healthy Chinese volunteers under both fasting and fed conditions. Numbers of enrolled subjects were 30 and 24 for fasting and fed treatments, respectively. Blood samples were drawn and collected predose as well as up t...
Source: Clinical Pharmacology in Drug Development - Category: Drugs & Pharmacology Authors: Tags: Original Manuscript Source Type: research
CONCLUSION: Our results implicated that even though each group has different predictors of social functioning, early traumatic events and HRV could be important indicators of functional outcome irrespective of what group they are. PMID: 31587532 [PubMed - as supplied by publisher]
Source: Psychiatry Investigation - Category: Psychiatry Tags: Psychiatry Investig Source Type: research
This study aims to investigate if sleep disturbances are related to cognitive impairments in schizophrenia spectrum (SCZ) and bipolar disorders (BD), if this relationship varies between different sleep disturbances (insomnia, hypersomnia or delayed sleep phase (DSP)) and lastly, if this relationship differs between clinical groups and healthy controls (HC). We included 797 patients (SCZ = 457, BD = 340) from the Norwegian Centre for Mental Disorders Research (NORMENT) study in Norway. Sleep disturbances were based on items from the Inventory of Depressive Symptoms-Clinician rated scale (IDS-C). ...
Source: European Archives of Psychiatry and Clinical Neuroscience - Category: Psychiatry Tags: Eur Arch Psychiatry Clin Neurosci Source Type: research
Abstract BACKGROUND: Bipolar disorder (BD) is a highly heritable mood disorder with complex genetic architecture and poorly understood etiology. Previous transcriptomic BD studies have had inconsistent findings due to issues such as small sample sizes and difficulty in adequately accounting for confounders like medication use. METHODS: We performed a differential expression analysis in a well-characterized BD case-control sample (Nsubjects = 480) by RNA sequencing of whole blood. We further performed co-expression network analysis, functional enrichment, and cell type decomposition, and integrated differentia...
Source: Psychological Medicine - Category: Psychiatry Authors: Tags: Psychol Med Source Type: research
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