Mohrschulz5866

those who were only taking medications subject to no or moderate GDI at week 8 were significantly less likely to experience AEs than those who were still taking at least one medication subject to significant GDI (RR 0.39, 95% CI 0.15-0.99, p=0.048). No other significant differences in risk were observed at week 8.

These data indicate that patient safety in the combinatorial pharmacogenomic test-guided care arm was no worse than TAU in the GUIDED trial. Moreover, combinatorial pharmacogenomic-guided medication selection may reduce some safety concerns. Collectively, these data demonstrate that combinatorial pharmacogenomic testing can be adopted safely into clinical practice without risking symptom degradation among patients.

Myriad Neuroscience/Assurex Health.

Myriad Neuroscience/Assurex Health.

Few studies have examined treatment response in adolescents with schizophrenia who are treatment-naive; and there is no placebo-controlled study that we are aware of in first episode treatment-naive patients with schizophrenia. The aim of this analysis was to evaluate the long-term efficacy of lurasidone in antipsychotic-naive adolescents with schizophrenia.

Patients aged 13-17 years with schizophrenia, and a PANSS total score ≥70 and <120, were randomized to 6 weeks of double-blind (DB) treatment with lurasidone (40 or 80 mg/day) or placebo. Six-week completers were eligible to enroll in a 2-year open-label extension phase receiving lurasidone flexibly dosed from 20-80 mg/day. In a post-hoc analysis, efficacy was evaluated for 2 patient groups based on treatment status prior to entering the initial 6-week DB study (treatment naïve [TN] vs. treated previously [TP]). Treatment-naïve was defined as never having received antipsychotic treatment. Efficacy measures included the PANSS total score and the Cliseline mean CGAS scores indicated significant functional impairment in both the TN and TP patients (CGAS=48 and 43, respectively). During OL treatment with lurasidone, mean change (from DB baseline) in the CGAS score at Weeks 52 and 104, respectively, was +22.0 and +22.9 in TN patients, and +21.1 and +22.9 in TP patients. During OL treatment with lurasidone, mean observed change from DB baseline in the weight (in kg,) at Weeks 52 and 104, respectively, was +4.2 and +4.8 in TN patients, and +4.0 and +5.0 in TP patients. These weight increases are consistent with expected weight gains in adolescents during a 2-year period (based on CDC growth charts).

In this post-hoc analysis of a 2-year study, adolescents with schizophrenia who had received no previous antipsychotic therapy showed greater improvement compared to previously treated patients during both short- and long-term treatment with lurasidone.

Sunovion Pharmaceuticals Inc.

Sunovion Pharmaceuticals Inc.Medical decision-making capacity (MDMC) is inherent to the legal and ethical principles of respect for autonomy and is an essential element of informed consent. Qualitative and quantitative evidence to support a final decision of capacity should be the gold standard. General hospital policies and state laws mandate that a licensed provider make the final determination of capacity, but they do not specifically mandate who is responsible for those assessments. When a patient s decisional capacity fluctuates, the role of the nurse in a hospital setting is valuable because they have the most direct contact with the patient. Objective Determine receptiveness of nursing staff to assessing capacity, to gather feedback on the Aid to Capacity Evaluation (ACE) tool, and to ascertain awareness of capacity by sixty nurses working on progressive care, trauma orthopedic, and medical/surgical units. Method This project was completed at a Midwestern academic level I trauma center. Nurses on a medical/surgical, orthopedic tra. Furthermore, providers would benefit from the extra time to gather information and complete focused assessments to make a determination of capacity with confidence.

The randomized, controlled, phase 3b ALPINE study evaluated efficacy and safety of a 2-month formulation of aripiprazole lauroxil (AL) initiated with a 1-day regimen during hospitalization for an acute exacerbation of schizophrenia; paliperidone palmitate (PP) was included as an active control. The primary efficacy outcome, within-group change from baseline in PANSS total score at 4 weeks, was previously reported. Here we report additional exploratory PANSS subscale endpoints and patient-reported outcomes (PROs).

Adults aged 18-65 years were enrolled as inpatients and randomized to AL 1064 mg q8wk or PP 156 mg q4wk and discharged after 2 weeks of study treatment if clinically stable. Patients were followed as outpatients through week 25. Exploratory efficacy endpoints were PANSS subscale (Positive, Negative, and General) and Clinical Global Impression-Severity (CGI-S) scores. The Burden Assessment Scale was administered to patients' nonprofessional caregivers (family member or friend). Exploratory PROs (Q-74.7% of AL-treated patients were somewhat or very satisfied with treatment. Mean Q-LES-Q-SF total scores were stable. With PP, PANSS subscale and CGI-S scores improved from baseline to study end (LS mean [95% CI] changes at week 25 Positive, -7.1 [-8.2, -5.9]; Negative, -3.5 [-4.6, -2.5]; General, -10.4 [-12.1, -8.6]; CGI-S, -1.2 [-1.5, -1.0]). Mean caregiver burden decreased (week 9 -8.8; week 25 -9.2). Most PP patients were satisfied or very satisfied with treatment (64.7%-69.3% at weeks 5, 9, and 17), and mean Q-LES-Q-SF total scores were stable.

In ALPINE, patients who initiated AL or PP in the hospital and continued treatment during outpatient care experienced improvement in schizophrenia symptoms and reported satisfaction with medication, decreased caregiver burden, and stable quality of life.

Alkermes, Inc.

Alkermes, Inc.

Cariprazine, a dopamine D3-preferring D3/D2 and serotonin 5-HT1A receptor partial agonist, is approved for the treatment of schizophrenia and for depressive, manic, or mixed episodes associated with bipolar I disorder. Previous post hoc analyses have demonstrated that cariprazine was effective versus placebo for improving cognitive symptoms in patients with schizophrenia or bipolar depression. This post hoc analysis evaluated the effects of cariprazine on cognitive symptoms in patients with acute manic or mixed bipolar episodes.

Data from 3 phase II/III, randomized, double-blind, placebo-controlled studies in patients with manic or mixed episodes associated with bipolar I disorder (NCT00488618, NCT01058096, NCT01058668) were pooled and analyzed. Patients were randomized to placebo or flexibly dosed cariprazine (3-12 mg/d, 3-6 mg/d, or 6-12 mg/d [1 study only]) for 3 weeks of double-blind treatment; all dose groups were combined for the pooled analysis. Cognitive symptoms were assessed using the Positive aor cariprazine- versus placebo-treated patients on YMRS total score (-16.7 vs -8.2; P<.0001) and the individual PANSS cognitive subscale items of conceptual disorganization (-1.1 vs -0.5; P=.0004), difficulty in abstract thinking (-0.8 vs -0.3; P=.0044), stereotyped thinking (-0.3 vs -0.1; P=.0350), and poor attention (-1.1 vs -0.6; P=.0043).

In patients with manic or mixed episodes associated with bipolar I disorder, cariprazine versus placebo was effective in improving cognitive symptoms in the overall patient population as well as in patients with baseline cognitive symptoms. In addition, cariprazine versus placebo also demonstrated efficacy in improving manic symptoms in patients with baseline cognitive symptoms. These results suggest that cariprazine may provide benefits for the treatment of cognitive symptoms in patients with bipolar I mania.

AbbVie Inc.

AbbVie Inc.

The delusion of being a living animate non-animal object has not heretofore been reported.

A 21-year-old right-handed cisgender female, two months prior to presentation, noted stiffness and difficulty with ambulation. One-month prior to admission, she experienced recurrent depression with myriad vegetative and nonvegetative symptoms of depression. On admission her chief complaint was I am a tree, standing motionless and minimally responding to query. After treatment with quetiapine, mirtazapine and hydroxyzine for a one-week period, her perception of being a tree fully resolved.

Abnormalities in Mental Status Examination Anxious mood repeatedly stating, I am a tree. Standing still for long periods of time, refusing blood pressure to be obtained and expressing fear of constricting flow. Neuropsychiatric Testing Beck Depression Inventory Type II 33 (severe depression).

The rapid response to risperidone is consistent with Cotard's syndrome, which has been noted to respond rapidly to neuroleptics (Sharma,icals. In Fregoli syndrome, there is an altered physical identity of others. In Reverse Fregoli syndrome, the sufferer assumes the physical but not the psychological identity of the stranger (Silva, 1990). But in this instance, the stranger is human as opposed to a plant life form. In the current case there is only altered physical identity (into a tree) not psychological identity. The current case may also be interpreted as a Botanical Variant of Interparietal Syndrome. In this condition, parts of the body are perceived to be lifeless, due to lesions of the inferior parietal lobe including supramarginalis gyrus, angular gyrus and the basalis parietalis area (Angyal, 1935). Investigation for those whom have Intermetamorphosis, Fregoli syndrome, Capgras syndrome, Interparietal syndrome, and Cotard's syndrome for the presence of delusions involving plant life is warranted.

Evaluate safety and tolerability of an aripiprazole lauroxil (AL) 2-month regimen using 1-day initiation in patients hospitalized for acute exacerbation of schizophrenia and transitioned to outpatient care.

In the 25-week, double-blind ALPINE study, adults hospitalized for an acute exacerbation of schizophrenia were randomized to AL (AL NanoCrystal Dispersion + oral aripiprazole 30 mg day 1; AL 1064 mg day 8 and q8wk) or the active control paliperidone palmitate (PP 234 mg day 1; PP 156 mg day 8 and q4wk), discharged after 2 weeks if clinically stable, and followed through the end of the study. Adverse events, including adverse events of special interest (AESIs; extrapyramidal symptoms [identified by non-mutually exclusive standardized MedDRA queries], sedation, hypotension, injection site reactions [ISRs], suicidal ideation and behavior) were monitored throughout the study.

In total, 200 patients were randomized (AL, n=99; PP, n=101); 99 patients (AL, n= 56; PP, n=43) completed the study. Rates of AESIs in AL-treated patients were akathisia, 10%; Parkinson-like events, 2%; dyskinesia, 3%; dystonia, 9%; sedation, 7%; hypotension, 6%; ISRs, 18 % (including placebo); and suicidal ideation and behavior, 2 %. Protigenin In PP-treated patients, AESI rates were akathisia, 12%; Parkinson-like events, 4%; dyskinesia, 5%; dystonia, 11%; sedation, 7%; hypotension, 4%; ISRs, 27% (including placebo); and suicidal ideation and behavior, 3%.

No unexpected safety and tolerability findings were identified in patients treated with AL or PP who were hospitalized for acute schizophrenia exacerbation and transitioned to outpatient care in ALPINE. AESI profiles were consistent with each treatment's respective known safety profile.

Alkermes, Inc.

All authors are employees of Alkermes, Inc., and may own stock/options in the company.

All authors are employees of Alkermes, Inc., and may own stock/options in the company.