Article Abstract Objective: This study evaluated the efficacy, safety, and tolerability of aripiprazole lauroxil, a novel long-acting injectable atypical antipsychotic, for treatment schizophrenia. Method: An international multicenter, randomized, double-blind, placebo-controlled trial was conducted between December 2011 March 2014. Patients (N = 623) aged 18 to 70 years with schizophrenia (DSM-IV-TR criteria), experiencing an acute exacerbation, were randomized in 1:1:1 ratio receive...

Pimavanserin is a 5-hydroxytryptamine-2A antagonist and inverse receptor agonist. This phase 2 study examined the efficacy safety of pimavanserin as adjunctive therapy in patients with major depressive disorder (MDD).This was multicenter, randomized, double-blind, placebo-controlled DSM-5-defined MDD an inadequate response to selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine (SNRI). Using 2-stage sequential parallel-comparison design, were initially randomized 3:1...

Aripiprazole lauroxil, a long-acting injectable antipsychotic, demonstrated safety and efficacy in treating symptoms of schizophrenia double-blind, placebo-controlled trial. Because the metabolic profile antipsychotics is an important feature, effects aripiprazole lauroxil on body weight, endocrine profiles, were examined secondary analysis.Patients with (DSM-IV-TR criteria) randomly assigned to 441 mg, 882 or placebo intramuscularly once monthly between December 2011 March 2014. Changes...

Inadequate response to antipsychotic treatment is common in patients with schizophrenia. This study evaluated pimavanserin, a 5-HT

This study aimed to evaluate the effects of aripiprazole lauroxil on hostility and aggressive behavior in patients with schizophrenia. Patients aged 18-70 years a diagnosis schizophrenia currently experiencing an acute exacerbation or relapse were randomized intramuscular (IM) 441 mg (n=207), 882 (n=208), placebo (n=207) for 12 weeks. In post-hoc analyses, aggression assessed by Positive Negative Syndrome Scale (PANSS) Hostility item (P7) specific antihostility effect was adjusting positive...

IntroductionPimavanserin, a selective 5-HT2A inverse agonist/antagonist, was approved for hallucinations and delusions associated with Parkinson's disease psychosis (PDP). We present durability of response pimavanserin in patients PDP an additional 4 weeks treatment.MethodsThis open-label extension (OLE) study previously completing one three double-blind, placebo-controlled (Core) studies. All received 34 mg once daily. Efficacy assessments included the Scale Assessment Positive Symptoms...

Pimavanserin is FDA-approved to treat Parkinson's disease (PD) psychosis. We analyzed the effect of pimavanserin on psychosis in PD dementia (PDD) subgroup from phase 3 HARMONY trial.

Background: Parkinson’s disease psychosis (PDP) is a common nonmotor symptom that affects up to 60% of patients. Pimavanserin, selective 5-HT2A inverse agonist/antagonist, approved for treating hallucinations and delusions associated with PDP. Objective: Evaluate the efficacy tolerability pimavanserin in an open-label extension (OLE) study. Methods: Patients completing pivotal 6-week placebo-controlled trial (Core Study) could enroll OLE. All patients 34 mg once daily, blinded previous...

Background Sexual dysfunction is common among patients with major depressive disorder (MDD). In the CLARITY study, safety and efficacy of adjunctive pimavanserin, an inverse agonist at 5-HT2A receptors, were demonstrated when added to existing treatment for MDD. This analysis provides a detailed assessment effects pimavanserin on sexual function from study. Methods Patients diagnosis MDD in episode, inadequate response ongoing antidepressant therapy, Montgomery-Åsberg Depression Rating Scale...

In a post hoc analysis, the effect of pimavanserin on anxious depression was determined from CLARITY, randomized, double-blind, placebo-controlled study in patients with major and an inadequate response to previous therapy. Patients were randomized 3:1 ratio placebo or 34 mg daily added ongoing antidepressant At 5 weeks, nonresponders rerandomized for additional weeks. Mean change baseline week Hamilton rating scale (HAMD) anxiety/somatization (AS) factor examined all those score ≥7 at...

Adjunctive pimavanserin can reduce depressive symptoms and improve function in patients with major depression inadequate antidepressant response. This analysis evaluated the effects of adjunctive on sleep/wakefulness disturbances.

Personality disorders frequently are seen among depressed psychiatric inpatients. In a group of 73 outpatients, this study identified 85% whose response to the Millon Clinical Multiaxial Inventory (MCMI) suggested personality disorder. On retest 12 weeks later, only 64% manifested style consistent with DSM-III disorders. These findings discussed in relation methodology, characteristics MCMI, and patient, which may lead an overidentification on self-report measure. Related aspects diagnostic...

Up to 15% of patients with major depressive disorder (MDD) attempt suicide and up 2% complete suicide. This was a post-hoc analysis aimed evaluate the risk ideation behavior associated adjunctive pimavanserin treatment in adults MDD.CLARITY randomized, double-blind, placebo-controlled study MDD an inadequate response selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine (SNRI). For this analysis, primary endpoint mean change from baseline for HAMD item 3 (suicide). The...

The sensitivity of personality measurement to emotional state has been indicated in several studies. This study explored the effect depressive on assessment with Millon Clinical Multiaxial Inventory II (MCMI-II). Posttreatment showed significant decrease scores schizoid, avoidant, self-defeating, and schizotypal scales when contrasted pretreatment assessment. Reduction Hamilton Rating Scale for Depression was correlated reduced schizoid self-defeating scales, increased narcissistic scale....

The Millon Clinical Multiaxial Inventory (MCMI) is a promising, yet somewhat unproven psychometric inventory developed to identify clinical syndromes and personality traits consonant with the Diagnostic Statistical Manual of Mental Disorders (3rd ed. [DSM-III]; American Psychiatric Association, 1980). stability its measures for both theoretically more stable characteristics was investigated in group depressed psychiatric outpatients. In this test-retest design 3-month interval between tests,...

Abstract Dementia-related psychosis (DRP) is common among patients with Alzheimer’s disease (AD), Parkinson’s (PD), dementia Lewy bodies (DLB), frontotemporal (FTD), and vascular (VaD) associated poor outcomes. HARMONY (NCT03325556) was a Phase 3, placebo-controlled, randomized, relapse-prevention study evaluating the efficacy safety of pimavanserin for treating hallucinations delusions DRP. Patients moderate-severe received open-label (OL) 12 weeks. sustained response (≥30% reduction in...

Abstract Dementia-related psychosis (DRP) is common among patients with Alzheimer’s disease (AD), Parkinson’s (PD), dementia Lewy bodies (DLB), frontotemporal (FTD), and vascular (VaD) associated poor outcomes. HARMONY (NCT03325556) was a Phase 3, placebo-controlled, randomized, relapse-prevention study evaluating the efficacy safety of pimavanserin for treating hallucinations delusions DRP. Patients moderate-severe received open-label (OL) 12 weeks. sustained response (≥30% reduction in...

Tuesday, April 28April 14, 2020Free AccessLong-term Evaluation of Open-label Pimavanserin Safety and Tolerability in Parkinson’s Disease Psychosis (2096)Clive Ballard, David Kreitzman, Stuart Isaacson, James Norton, George Demos, I-Yuan Liu, Hubert Fernandez, Tihomir Ilic, Jean Azulay, Joaquim Ferreira, Victor Abler, Srdjan StankovicAuthors Info & AffiliationsApril 2020 issue94 (15_supplement)https://doi.org/10.1212/WNL.94.15_supplement.2096 Letters to the Editor