Robert Riesenberg
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View article: Cariprazine for the Adjunctive Treatment of Major Depressive Disorder in Patients With Inadequate Response to Antidepressant Therapy
Cariprazine for the Adjunctive Treatment of Major Depressive Disorder in Patients With Inadequate Response to Antidepressant Therapy Open
Clinical Trials Registration: ClinicalTrials.gov identifier NCT03739203.
View article: Cariprazine in Pediatric Patients with Autism Spectrum Disorder: Results of a Pharmacokinetic, Safety and Tolerability Study
Cariprazine in Pediatric Patients with Autism Spectrum Disorder: Results of a Pharmacokinetic, Safety and Tolerability Study Open
Objective: Cariprazine is a dopamine D3-preferring D3/D2 and serotonin 5-HT1A receptor partial agonist approved to treat adults with schizophrenia and manic/mixed or depressive episodes associated with bipolar I disorder. This study, which…
View article: Evaluation of BNT162b2 Covid-19 Vaccine in Children Younger than 5 Years of Age
Evaluation of BNT162b2 Covid-19 Vaccine in Children Younger than 5 Years of Age Open
A three-dose primary series of 3-μg BNT162b2 was safe, immunogenic, and efficacious in children 6 months to 4 years of age. (Funded by BioNTech and Pfizer; ClinicalTrials.gov number, NCT04816643.).
View article: Oral ENT-01 Targets Enteric Neurons to Treat Constipation in Parkinson Disease
Oral ENT-01 Targets Enteric Neurons to Treat Constipation in Parkinson Disease Open
Enterin, Inc.
View article: Pharmacokinetics, Safety, and Tolerability of Cariprazine in Pediatric Patients with Bipolar I Disorder or Schizophrenia
Pharmacokinetics, Safety, and Tolerability of Cariprazine in Pediatric Patients with Bipolar I Disorder or Schizophrenia Open
Objective: Cariprazine is a dopamine D3-preferring D3/D2 and serotonin 5-HT1A receptor partial agonist approved to treat adults with schizophrenia and manic/mixed or depressive episodes associated with bipolar I disorder. This sequential-c…
View article: Effect of brexanolone on depressive symptoms, anxiety, and insomnia in women with postpartum depression: Pooled analyses from 3 double-blind, randomized, placebo-controlled clinical trials in the HUMMINGBIRD clinical program
Effect of brexanolone on depressive symptoms, anxiety, and insomnia in women with postpartum depression: Pooled analyses from 3 double-blind, randomized, placebo-controlled clinical trials in the HUMMINGBIRD clinical program Open
Brexanolone was associated with rapid improvement in depressive symptoms and symptoms of anxiety and insomnia compared with placebo in women with PPD. These data continue to support the use of brexanolone to treat adults with PPD.
View article: Efficacy and Safety of NVX-CoV2373 in Adults in the United States and Mexico
Efficacy and Safety of NVX-CoV2373 in Adults in the United States and Mexico Open
NVX-CoV2373 was safe and effective for the prevention of Covid-19. Most breakthrough cases were caused by contemporary variant strains. (Funded by Novavax and others; PREVENT-19 ClinicalTrials.gov number, NCT04611802.).
View article: Efficacy and Safety of NVX-CoV2373 in Adults in the United States and Mexico
Efficacy and Safety of NVX-CoV2373 in Adults in the United States and Mexico Open
BACKGROUND Vaccination using severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike (S) protein antigen has been effective in the prevention of coronavirus disease 2019 (Covid-19). NVX-CoV2373 is an adjuvanted, recombinant S pr…
View article: Treatment Outcomes in Patients Treated With Galcanezumab vs Placebo: Post Hoc Analyses From a Phase 3 Randomized Study in Patients With Episodic Cluster Headache
Treatment Outcomes in Patients Treated With Galcanezumab vs Placebo: Post Hoc Analyses From a Phase 3 Randomized Study in Patients With Episodic Cluster Headache Open
Background Cluster headache (CH) is a highly disabling primary headache disorder. To date, characterization of outcomes in the preventive treatment of episodic CH, including precise definitions of clinically meaningful attack frequency red…
View article: PF-06649751 efficacy and safety in early Parkinson’s disease: a randomized, placebo-controlled trial
PF-06649751 efficacy and safety in early Parkinson’s disease: a randomized, placebo-controlled trial Open
Background: PF-06649751 is a novel, oral, non-catechol-based, D1/D5 dopamine receptor partial agonist under investigation for the treatment of motor symptoms associated with Parkinson’s disease. Methods: A 15-week, phase II, double-blind, …
View article: Trial of SAGE-217 in Patients with Major Depressive Disorder
Trial of SAGE-217 in Patients with Major Depressive Disorder Open
Administration of SAGE-217 daily for 14 days resulted in a reduction in depressive symptoms at day 15. Adverse events were more common in the SAGE-217 group than in the placebo group. Further trials are needed to determine the durability a…
View article: Liraglutide effects in a paediatric (7‐11 y) population with obesity: A randomized, double‐blind, placebo‐controlled, short‐term trial to assess safety, tolerability, pharmacokinetics, and pharmacodynamics
Liraglutide effects in a paediatric (7‐11 y) population with obesity: A randomized, double‐blind, placebo‐controlled, short‐term trial to assess safety, tolerability, pharmacokinetics, and pharmacodynamics Open
Summary Background Childhood obesity is a major public health concern with limited treatment options. Objective The aim of this study was to assess safety, tolerability, pharmacokinetics, and pharmacodynamics during short‐term treatment wi…
View article: Lasmiditan is an effective acute treatment for migraine
Lasmiditan is an effective acute treatment for migraine Open
This study provides Class I evidence that for adult patients with migraine, lasmiditan increases the proportion of subjects who are headache pain free at 2 hours after treating a migraine attack.
View article: Asenapine pharmacokinetics and tolerability in a pediatric population
Asenapine pharmacokinetics and tolerability in a pediatric population Open
Asenapine was generally safe and well tolerated in pediatric patients aged 10-17 years. PK and safety data were similar to that observed in the adult population. Intrinsic factors had no significant impact on asenapine exposure, indicating…
View article: Evaluation of the Efficacy, Safety, and Tolerability of BI 409306, a Novel Phosphodiesterase 9 Inhibitor, in Cognitive Impairment in Schizophrenia: A Randomized, Double-Blind, Placebo-Controlled, Phase II Trial
Evaluation of the Efficacy, Safety, and Tolerability of BI 409306, a Novel Phosphodiesterase 9 Inhibitor, in Cognitive Impairment in Schizophrenia: A Randomized, Double-Blind, Placebo-Controlled, Phase II Trial Open
The primary endpoint of cognitive function improvement was not met. BI 409306 was well-tolerated, with an acceptable safety profile.
View article: 21. Evaluation of the Efficacy, Safety, and Tolerability of BI 409306, a Novel Phosphodiesterase 9 Inhibitor, in Cognitive Impairment in Schizophrenia: A Randomized, Double-Blind, Placebo-Controlled, Phase II Study
21. Evaluation of the Efficacy, Safety, and Tolerability of BI 409306, a Novel Phosphodiesterase 9 Inhibitor, in Cognitive Impairment in Schizophrenia: A Randomized, Double-Blind, Placebo-Controlled, Phase II Study Open
\nBackground: Currently approved antipsychotics have not demonstrated efficacy in cognitive impairment associated with schizophrenia (CIAS). This study evaluated the efficacy, safety, and tolerability of BI 409306, a potent and selective p…
View article: Multiple dose pharmacokinetics of inhaled loxapine in subjects on chronic, stable antipsychotic regimens
Multiple dose pharmacokinetics of inhaled loxapine in subjects on chronic, stable antipsychotic regimens Open
This randomized, double‐blind, placebo‐controlled, parallel‐group study was to determine the pharmacokinetic characteristics, safety, and tolerability of multiple doses of inhaled loxapine aerosol in subjects on a stable, oral, chronic ant…