ziprasidone ER / Lipocine - LARVOL DELTA

Lurasidone compared to other atypical antipsychotic monotherapies for adolescent schizophrenia: a systematic literature review and network meta-analysis. (PubMed, Eur Child Adolesc Psychiatry) - "A Bayesian network meta-analysis compared lurasidone to aripiprazole, asenapine, clozapine, olanzapine, paliperidone extended-release (ER), quetiapine, risperidone, and ziprasidone. Rates of EPS and akathisia were similar for lurasidone and other atypical antipsychotics. In this network meta-analysis of atypical antipsychotics in adolescent schizophrenia, lurasidone was associated with similar efficacy, less weight gain, and lower risk of all-cause discontinuation compared to other oral atypical antipsychotics."

Journal • Retrospective data • CNS Disorders • Psychiatry • Schizophrenia

[VIRTUAL] The Comparative Pharmacoeconomic Analysis of Using Tetrabenazine for Patients with Huntington's Disease in Russia (ISPOR-EU 2020) - " Analysis of the published clinical trials was conducted to evaluate comparative efficacy and safety of using different types of drugs for the treatment of chorea in HD used in Russia – tetrabenazine and neuroleptics (tiapride, olanzapine, risperidone, aripiprazole, ziprasidone and quetiapine). Using tetrabenazine for treating chorea in patients with HD was effective and economically justified treatment option in Russia."

Clinical • HEOR • CNS Disorders • Cognitive Disorders • Huntington's Disease • Mental Retardation • Movement Disorders • Psychiatry

Extension Study Evaluating The Safety And Tolerability Of Flexible Doses Of Oral Ziprasidone In Children And Adolescents With Bipolar I Disorder (clinicaltrials.gov) - P3; N=23; Terminated; Sponsor: Pfizer; N=55 ➔ 23; Recruiting ➔ Terminated; Pfizer has decided to perform the pre-specified final analysis at the current enrollment using a re-estimation of the sample size.

Clinical • Enrollment change • Trial termination • Bipolar Disorder • CNS Disorders • Mood Disorders • Psychiatry

Extension Study Evaluating The Safety And Tolerability Of Flexible Doses Of Oral Ziprasidone In Children And Adolescents With Bipolar I Disorder (clinicaltrials.gov) - P3; N=55; Recruiting; Sponsor: Pfizer; Trial completion date: Jul 2021 ➔ Aug 2020; Trial primary completion date: Jul 2021 ➔ Aug 2020

Clinical • Trial completion date • Trial primary completion date • Bipolar Disorder • CNS Disorders • Mood Disorders

PERSPECTIVES: Insurance markets, labor markets, and the mental health services delivery system. (PubMed, J Ment Health Policy Econ) - "This work demonstrated, using a price adjustment process, that there is no viable price that would make aripiprazole cost-effective for incorporation in the Brazilian public health system in the first-line of treatment of schizophrenia. The drug can be useful in specific cases, since individual variability of response to antipsychotic drugs is important."

Journal • Reimbursement • CNS Disorders • Psychiatry • Schizophrenia

Efficacy and Safety Trial of Flexible Doses of Oral Ziprasidone in Children and Adolescents With Bipolar I Disorder (clinicaltrials.gov) - P3; N=194; Terminated; Sponsor: Pfizer; Trial completion date: Jan 2021 ➔ May 2020; Recruiting ➔ Terminated; Trial primary completion date: Nov 2020 ➔ May 2020; Based on recent input from FDA, the pre-specified final analysis will be performed at the current enrollment using a re-estimation of the sample size.

Clinical • Trial completion date • Trial primary completion date • Trial termination • Bipolar Disorder • CNS Disorders • Mood Disorders

Validation and Clinical Utility of the hERG IC50/Cmax Ratio to Determine the Risk of Drug Induced Torsades de Pointes: A Meta-Analysis. (PubMed, Pharmacotherapy) - "The hERG IC50/Cmax ratio was correlated with TdP incidence for culprit drugs. This validation provides support for the potential use of the hERG IC50/Cmax ratio for clinical decision making in instances of drug selection where TdP risk is a concern."

Journal • Retrospective data • Biosimilar • CNS Disorders

Quetiapine-Induced Thrombocytopenia Leading to Subarachnoid Hemorrhage: Case Report (APA 2017) - "...The primary team decided to wean the patient off quetiapine and start her on ziprasidone, with a goal dosage of 80mg twice daily...found two cases who demonstrated transient thrombocytopenia that resolved on stopping quetiapine. There are few other case reports of blood dyscrasias associated with quetiapine use like pancytopenia, leucopenia and neutropenia."

Adverse drug reaction • Clinical • Biosimilar • Bipolar Disorder • CNS Disorders • Demo Pain • Depression • Hematological Malignancies • Immunology • Oncology • Pain • Venous Thromboembolism

Physiologically-based pharmacokinetics of ziprasidone in pregnant women. (PubMed, Br J Clin Pharmacol) - "The PBPK model predicted the impact of physiological changes during pregnancy on PK and exposure of ziprasidone, suggesting that dose adjustment is not necessary in this special population."

Clinical • Journal • PK/PD data

Comparative efficacy and tolerability of pharmacological treatments for the treatment of acute bipolar depression: A systematic review and network meta-analysis. (PubMed, J Affect Disord) - "These results could serve evidence-based practice and inform patients, physicians, guideline developers, and policymakers on the relative benefits of the different antidepressants, antipsychotics, and mood-stabilizing agents for the treatment of bipolar depression."

Journal • Retrospective data • Review • Bipolar Disorder • CNS Disorders • Depression • Mood Disorders • Psychiatry

Akathisia and Atypical antipsychotics: Exploring Associations to Suicidality and Agitation (SIRS 2020) - "Methods This study is a sub-study of the Bergen Psychosis Project (BPP), a pragmatic, rater-blind, randomized trial comparing head-to-head ziprasidone, olanzapine, risperidone and quetiapine. Conclusion Akathisia is still a prevalent phenomenon in a substantial proportion of patients treated with atypical antipsychotics. Special attention is called for regarding the association towards suicidality."

Clinical Pharmacokinetics of Atypical Antipsychotics: An Update. (PubMed, Clin Pharmacokinet) - "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."

Clinical • Journal • PK/PD data • Review

Comparative efficacy and tolerability of 32 oral antipsychotics for the acute treatment of adults with multi-episode schizophrenia: a systematic review and network meta-analysis. (PubMed, Lancet) - "There are some efficacy differences between antipsychotics, but most of them are gradual rather than discrete. Differences in side-effects are more marked. These findings will aid clinicians in balancing risks versus benefits of those drugs available in their countries. They should consider the importance of each outcome, the patients' medical problems, and preferences."

Journal • Retrospective data • Review

Efficacy and Safety Trial of Flexible Doses of Oral Ziprasidone in Children and Adolescents With Bipolar I Disorder (clinicaltrials.gov) - P3; N=194; Recruiting; Sponsor: Pfizer; Trial completion date: Oct 2020 ➔ Jan 2021

Clinical • Trial completion date

Extension Study Evaluating The Safety And Tolerability Of Flexible Doses Of Oral Ziprasidone In Children And Adolescents With Bipolar I Disorder (clinicaltrials.gov) - P3; N=55; Recruiting; Sponsor: Pfizer; Trial completion date: Apr 2021 ➔ Jul 2021; Trial primary completion date: Apr 2021 ➔ Jul 2021

Clinical • Trial completion date • Trial primary completion date

Chronical treatment with sertindole, but not clozapine and ziprasidone, afects the activity of antioxidative enzymes in rat brain (Neuroscience 2019) - "Since both CAT and GPx catalyze decomposition of H2O2, increased activity of these enzymes in SER group suggests an elevated concentration of their substrate in brain. Furthermore, the activity of SOD can be decreased by elevated concentration of H2O2 which additionally indicates the presence of increased quantities of this reactive oxygen species. These suggest that SER could cause a redox imbalance in brain with possible negative effects on mitochondrial respiration and neural tissue metabolism."

Preclinical

Ziprasidone-loaded arabic gum modified montmorillonite-tailor-made pectin based gastroretentive composites. (PubMed, Int J Biol Macromol) - "The SEM studies revealed the spherical morphology of the composites. Thus, the newly developed DGP-AG-MMT composites are appropriate for gastroretentive ZIP delivery over an extended period of time."

Journal

Extension Study Evaluating The Safety And Tolerability Of Flexible Doses Of Oral Ziprasidone In Children And Adolescents With Bipolar I Disorder (clinicaltrials.gov) - P3; N=55; Recruiting; Sponsor: Pfizer; Trial completion date: Sep 2020 ➔ Apr 2021; Trial primary completion date: Sep 2020 ➔ Apr 2021

Clinical • Trial completion date • Trial primary completion date

Lurasidone compared to other atypical antipsychotic monotherapies for bipolar depression: A systematic review and network meta-analysis. (PubMed) - World J Biol Psychiatry - "In this network meta-analysis, lurasidone was found to be more efficacious than aripiprazole and ziprasidone, and was associated with less weight gain than quetiapine and olanzapine and less somnolence than quetiapine and ziprasidone."

Journal • Retrospective data • Review

Extension Study Evaluating The Safety And Tolerability Of Flexible Doses Of Oral Ziprasidone In Children And Adolescents With Bipolar I Disorder (clinicaltrials.gov) - P3; N=55; Recruiting; Sponsor: Pfizer; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open