- |||||||||| Latuda (lurasidone oral) / Sumitomo Dainippon
Does the Time of Drug Administration Alter the Adverse Event Risk of lurasidone? (Spadolini - Ground Floor) - Jan 17, 2020 - Abstract #SIRS2020SIRS_76;
Unlike with AM administration, the dose-dependence in the risks of these adverse events were not observed in lurasidone PM administration. The timing of lurasidone administration could be considered in effort to minimize potential adverse events.
- |||||||||| carbamazepine / Generic mfg., Latuda (lurasidone oral) / Sumitomo Dainippon, quetiapine / Generic mfg.
Clinical, Review, Journal: Pharmacological treatment of adult bipolar disorder. (Pubmed Central) - Jan 9, 2020
Treatment of BD-depression remains unsatisfactory but includes some modern antipsychotics (particularly lurasidone, olanzapine + fluoxetine, and quetiapine) and the anticonvulsant lamotrigine; value and safety of antidepressants remain controversial...Long-term treatment of BD also is limited by access to, and support of expert, comprehensive clinical programs. Pursuit of improved, rationally designed pharmacological treatments for BD, as for most psychiatric disorders, is fundamentally limited by lack of coherent pathophysiology or etiology.
- |||||||||| Review, Journal: Bipolar depression: a major unsolved challenge. (Pubmed Central) - Jan 7, 2020
Evidence of efficacy of lithium and anticonvulsants for bipolar depression is very limited; lamotrigine has long-term benefit, but valproate and carbamazepine are inadequately tested and carry high teratogenic risks. Evidence is emerging of short-term efficacy of several modern antipsychotics (including cariprazine, lurasidone, olanzapine-fluoxetine, and quetiapine) for bipolar depression, including with mixed features, though they risk adverse metabolic and neurological effects.
- |||||||||| Clinical, Journal: Hospitalization Risk in Bipolar Disorder Patients Treated with Lurasidone versus Other Atypical Antipsychotics. (Pubmed Central) - Jan 1, 2020
In this claims database analysis, lurasidone-treated patients with bipolar disorder had a significantly lower risk of psychiatric hospitalization compared to quetiapine, olanzapine, and risperidone, but not aripiprazole or ziprasidone. Lurasidone-treated patients had a significantly lower risk of all-cause hospitalization compared to quetiapine, olanzapine, risperidone, and aripiprazole, but not ziprasidone.
- |||||||||| Trial completion, Enrollment change, Trial completion date, Trial primary completion date: PTN_POPS: Pharmacokinetics of Understudied Drugs Administered to Children Per Standard of Care (clinicaltrials.gov) - Dec 12, 2019
P=N/A, N=3520, Completed,
It was concluded that oral administration of LH-SLNs in rats improved the bioavailability of LH via lymphatic uptake along with improved therapeutic effect in MK-801 induced schizophrenia model in rats. Recruiting --> Completed | N=10000 --> 3520 | Trial completion date: Feb 2020 --> Nov 2019 | Trial primary completion date: Feb 2020 --> Nov 2019
- |||||||||| Latuda (lurasidone oral) / Sumitomo Dainippon
Clinical, Journal: Sleep-Related Orgasms in a 57-Year-Old Woman: A Case Report. (Pubmed Central) - Nov 24, 2019
Sleep architecture was disturbed, with 96.4% of sleep spent in stage N2 sleep. Bedtime clonazepam therapy (1.5 mg) was effective in suppressing the sleep-related orgasms and hypnic jerks.
- |||||||||| Biomarker, Journal: Knowledge of the Pharmacology of Antidepressants and Antipsychotics Yields Results Comparable With Pharmacogenetic Testing. (Pubmed Central) - Nov 23, 2019
What was common among those drugs almost always in the green bin versus those almost never in the green bin were newer versus older marketed drugs and those not dependent versus dependent on oxidative metabolism for their clearance. The authors concluded that the results of this pharmacogenetic testing could be predicted on the basis of knowledge of the pharmacology of the drugs, particularly whether their clearance was dependent on oxidative drug metabolism.
- |||||||||| Clinical, PK/PD data, Review, Journal: Clinical Pharmacokinetics of Atypical Antipsychotics: An Update. (Pubmed Central) - Nov 2, 2019
This review concentrates on the clinical pharmacokinetic data related to clozapine, risperidone, paliperidone, olanzapine, quetiapine, amisulpride, ziprasidone, aripiprazole, sertindole, asenapine, iloperidone, lurasidone, brexpiprazole and cariprazine and briefly considers the main aspects of their pharmacodynamics. Optimal plasma concentration ranges are proposed for clozapine, risperidone, paliperidone and olanzapine because the studies of quetiapine, amisulpride, asenapine, iloperidone and lurasidone provide only limited information and there is no direct evidence concerning ziprasidone, aripiprazole, sertindole, brexpiprazole and cariprazine: the few reported investigations need to be confirmed and extended.
- |||||||||| Latuda (lurasidone oral) / Sumitomo Dainippon
miRNA30a-Related Changes in the Prenatal Stress Model and Modulation by Lurasidone Treatment: Implications for Psychiatric Disorders (Floridian Ballroom) - Oct 17, 2019 - Abstract #ACNP2019ACNP_1127;
This miRNA may represent a master regulator for the increased susceptibility to psychiatric disorders as a long-lasting consequence of early life stress exposure, by affecting pathways related to axon guidance and neurotrophin signaling. Moreover, chronic treatment with the antipsychotic drug lurasidone was able to prevent some of the changes produced by PNS with a major effect on miRNA30a levels as well as on its target genes LIMK, MAP2K2, and PIK3CA.
- |||||||||| Clinical, Review, Journal: Lurasidone in Children and Adolescents: Systematic Review and Case Report. (Pubmed Central) - Oct 9, 2019
There is increasing evidence that lurasidone may be moderately effective and well tolerated for the treatment of BD and psychosis in youth and may have procognitive effects. Our case report suggests that future RCTs should assess the efficacy and tolerability of high doses (>80 mg/day) of lurasidone in youth.
- |||||||||| Clinical, Journal: A Focused Review on the Treatment of Pediatric Patients with Atypical Antipsychotics. (Pubmed Central) - Oct 8, 2019
Maladaptive aggression in children, often treated with antipsychotics, is one such area in which there is a dearth of actual information available to the clinician. It is to be hoped that additional, longer-term studies of these medications will further inform evidence-based practice in clinical settings.
- |||||||||| lurasidone / Generic mfg.
Trial completion date, Trial primary completion date: A Study of Lurasidone HCl in Subjects With Schizophrenia (clinicaltrials.gov) - Sep 25, 2019
P4, N=62, Recruiting,
These findings were consistent across both structured assessments using a validated sexual functioning questionnaire (CSFQ) as well as adverse event reporting. Trial completion date: Aug 2019 --> Dec 2019 | Trial primary completion date: Aug 2019 --> Dec 2019
- |||||||||| Latuda (lurasidone oral) / Sumitomo Dainippon
Clinical, Journal: Clinical Relevance Versus Statistical Significance: DelBello and Colleagues Respond to Editorial. (Pubmed Central) - Aug 23, 2019
Special focus on long-term maintenance trials is required to further identify long-term AEs in this population. We would like to respond to some concerns raised by Dr. McClellan in his editorial comment on our article that reported the results of a placebo-controlled study of lurasidone for the treatment of children and adolescents with bipolar I depression..
- |||||||||| Clinical, Review, Journal: Efficacy and Tolerability of Atypical Antipsychotics in the Treatment of Delirium: A Systematic Review of the Literature. (Pubmed Central) - Aug 17, 2019
Although the current evidence of the efficacy and tolerability of AAPs in the treatment of delirium is limited and the heterogeneity of the data precluded a meta-analysis, olanzapine and quetiapine seem to be adequate alternatives to haloperidol, especially in patients who are vulnerable for extrapyramidal symptoms, who require sedation or who have a history of haloperidol intolerance. Evidently, larger-scale RCTs are urgently required.
- |||||||||| Latuda (lurasidone oral) / Sumitomo Dainippon
Biomarker, Clinical, Journal: C-reactive protein and response to lurasidone in patients with bipolar depression. (Pubmed Central) - Aug 3, 2019
Elevated CRP level prior to treatment was associated with an enhanced clinical response to lurasidone in patients with bipolar I depression. If confirmed in future studies, CRP may represent a clinically useful diagnostic and predictive biomarker supporting a precision medicine approach to the treatment of bipolar depression.
- |||||||||| ASP4345 / Astellas
Enrollment closed: A Study to Assess the Safety and Efficacy of ASP4345 as Add-on Treatment for Cognitive Impairment in Subjects With Schizophrenia on Stable Doses of Antipsychotic Medication (clinicaltrials.gov) - Jul 26, 2019
P2a, N=233, Active, not recruiting,
Moreover, we provide new insights on the mechanism of action of lurasidone, demonstrating that its chronic treatment normalizes CMS-induced PVB alterations, possibly by potentiating antioxidant mechanisms, which may ameliorate specific functions that are deteriorated in psychiatric patients. Recruiting --> Active, not recruiting
- |||||||||| Saphris (asenapine) / Allergan, Lundbeck, Meiji Seika, Latuda (lurasidone oral) / Sumitomo Dainippon
Clinical, Retrospective data, Journal: Asenapine, iloperidone and lurasidone exposures in young children reported to U.S. poison centers. (Pubmed Central) - Jul 5, 2019
These findings suggest that in children under 6 years of age, lurasidone exposures were least serious and iloperidone exposures were most serious based on clinical effects, management sites and coded outcomes. Observation of symptomatic children in the ED for 8 h should be sufficient to make triage decisions based on persistence or resolution of clinical effects.
- |||||||||| Latuda (lurasidone oral) / Sumitomo Dainippon
Clinical, Journal: Augmentation of phenelzine with aripiprazole and quetiapine in a treatment-resistant patient with psychotic unipolar depression: case report and literature review. (Pubmed Central) - Jul 4, 2019
In addition to the limited publication history on SGA-MAOI treatment, clinicians may also be deterred by uncertainty regarding SGA mechanisms and the risk of serotonin syndrome or other adverse outcomes. This paper describes the case of a 54-year-old male with a history of psychotic unipolar depression treated with a combination of phenelzine, aripiprazole, and quetiapine, and reviews the 12 published cases of SGA-MAOI combination therapy with a focus on the pharmacological basis for serotonin syndrome, and the SGA mechanisms that should not be associated with a risk for this syndrome.
- |||||||||| Latuda (lurasidone oral) / Sumitomo Dainippon
Journal: Lurasidone: A New Option for Older Adults with Bipolar Disorder? (Pubmed Central) - Jul 1, 2019
This paper describes the case of a 54-year-old male with a history of psychotic unipolar depression treated with a combination of phenelzine, aripiprazole, and quetiapine, and reviews the 12 published cases of SGA-MAOI combination therapy with a focus on the pharmacological basis for serotonin syndrome, and the SGA mechanisms that should not be associated with a risk for this syndrome. No abstract available
- |||||||||| Valdoxan (agomelatine) / Servier, Novartis, Edronax (reboxetine) / Pfizer, Latuda (lurasidone oral) / Sumitomo Dainippon
Clinical, Review, Journal: The emergence of new antidepressants for clinical use: Agomelatine paradox versus other novel agents. (Pubmed Central) - Jun 21, 2019
...The emerging antidepressants are: selective monoamine oxidase inhibitors (MAOIs) such as bifemelane, pirlindole, toloxatone, selegiline, rasagiline and safinamide; serotonin-norepinephrine reuptake inhibitors (SNRIs) such as ansofaxine, nefopam and levomilnacipran; norepinephrine reuptake inhibitors (NRIs) such as Reboxetine, viloxazine, teniloxazine (also known as sulfoxazine or sufoxazine), and atomoxetine; Vilazodone (a serotonin 5-HT autoreceptor partial agonist with serotonin reuptake inhibition [SPARI]); Vortioxetine (a serotonin receptors antagonist with serotonin reuptake inhibition [SARI]); atypical antipsychotics such as olanzapine, quetiapine, risperidone, lurasidone, aripiprazole and brexpiprazole; N-methyl-d-aspartate (NMDA)-glutamatergic neurotransmission system blockers such as ketamine, CP-101,606 (traxoprodil), GLYX-13 (rapastinel), NRX-1074 (Apimostinel) and Riluzole...receptors antagonist [MASSA]) remains a paradoxical agent that doesn't fit into any of the currently available classes of antidepressant agents and its pharmacological properties also deemed it unfit and inappropriate to be classified into another separate novel class of antidepressants contrary to the reports published in previous reference literatures. Lastly, this review remarkably advocates for the incorporation of the atypical antipsychotics and NMDA-glutamatergic ionoceptor blockers as new member classes of the antidepressant agents because of their clinically significant roles in the management of depression disorders.
- |||||||||| Cyclurad (cycloserine/lurasidone) / NeuroRx
Enrollment closed, Trial completion date, Trial primary completion date: SBD-ASIB: NRX-101 for Maintenance of Remission From Severe Bipolar Depression in Patients With Suicidal Ideation (clinicaltrials.gov) - Jun 19, 2019
P2/3, N=72, Active, not recruiting,
Lastly, this review remarkably advocates for the incorporation of the atypical antipsychotics and NMDA-glutamatergic ionoceptor blockers as new member classes of the antidepressant agents because of their clinically significant roles in the management of depression disorders. Not yet recruiting --> Active, not recruiting | Trial completion date: Mar 2020 --> Dec 2020 | Trial primary completion date: Dec 2019 --> Sep 2020
- |||||||||| Cyclurad (cycloserine/lurasidone) / NeuroRx
Biomarker, Enrollment closed: NRX-GLX: NRX101 Glx Biomarker Validation Study (clinicaltrials.gov) - Jun 18, 2019
P2/3, N=24, Active, not recruiting,
Not yet recruiting --> Active, not recruiting | Trial completion date: Mar 2020 --> Dec 2020 | Trial primary completion date: Dec 2019 --> Sep 2020 Recruiting --> Active, not recruiting
- |||||||||| Saphris (asenapine) / Allergan, Lundbeck, Meiji Seika, Latuda (lurasidone oral) / Sumitomo Dainippon, Geodon (ziprasidone) / RaQualia, Meiji Seika, Pfizer
Clinical, Review, Journal: The Safety of Second-Generation Antipsychotics During Pregnancy: A Clinically Focused Review. (Pubmed Central) - May 31, 2019
No or minimal safety data are available for amisulpride, asenapine, lurasidone, and sertindole...Furthermore, for neonatal adaption and childhood neurodevelopment, the data do not allow for a meaningful risk assessment. It is imperative that factors in addition to safety data, e.g. individual disease history, characteristics and treatment response, adverse reaction profile, and patient preferences, be considered for the individual patient when choosing specific SGA treatment during pregnancy.
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