Efficacy and Safety Considerations With Second-Generation Antipsychotics as Adjunctive Analgesics: A Review of Literature

2021 ◽  
pp. 875512252110041
Author(s):  
Belinda Coronado ◽  
Jacob Dunn ◽  
Michael A. Veronin ◽  
Justin P. Reinert
Keyword(s):  
Extended Release ◽  
Second Generation ◽  
Rating Scale ◽  
Data Extraction ◽  
Controlled Trial ◽  
Numeric Rating Scale ◽  
Efficacy And Safety ◽  
Study Selection ◽  
Second Generation Antipsychotics ◽  
Safety Considerations

Objective: To determine the efficacy and safety of second-generation antipsychotics (SGAs) as adjunctive analgesics. Data Sources: A comprehensive literature review was conducted between August 2020 and January 2021 on PubMed, Scopus, and ProQuest Central. Study Selection and Data Extraction: Keyword and Boolean phrase searches using the following terminology were conducted: “Quetiapine” OR “Risperidone” OR “Olanzapine” OR “Ziprasidone” AND “Analgesia” NOT “Psychosis” NOT “Psych.” Articles that involved human adult patients who received any of the SGAs mentioned in the searching filter with an opioid were included. Articles that described pediatrics, pregnant women, patients who received any of these agents for treatment of psychosis and articles that were not in English, or readily translatable to English, were excluded. Data Synthesis: Three articles were selected for inclusion in this review, with 2 articles detailing reports with olanzapine and 1 article describing a randomized, controlled trial with extended-release quetiapine. Both olanzapine and quetiapine were able to decrease pain scores on the numeric rating scale, indicating a reduction pain experienced, and additionally reduced opioid craving behavior in patients. Depression scores and quality-of-life indicators improved with quetiapine, though those metrics were not studied with olanzapine. Conclusions: Select SGAs, specifically extended-release quetiapine and olanzapine, may serve as an appropriate adjunctive analgesic choice in select patients. Further research is required in a clinical setting to determine the exact role of this drug class in pain management.

Neuroleptic Malignant Syndrome: No Longer Exclusively a “Neuroleptic” Phenomenon

2005 ◽  
Vol 21 (5) ◽  
pp. 262-270 ◽  
Author(s):  
Kurt A Wargo ◽  
Rahul Gupta
Keyword(s):  
Diagnostic Criteria ◽  
Neuroleptic Malignant Syndrome ◽  
First Generation ◽  
Second Generation ◽  
Case Reports ◽  
Data Extraction ◽  
Study Selection ◽  
Minor Criterion ◽  
Second Generation Antipsychotics ◽  
Review Reports

Objective: To review the literature concerning the incidence of neuroleptic malignant syndrome (NMS) associated with the use of atypical antipsychotics. Data Sources: Cases were identified through a search of MEDLINE (1986–March 2004) using the terms neuroleptic malignant syndrome, antipsychotic, clozapine, risperidone, olanzapine, quetiapine, ziprasidone, and aripiprazole. Study Selection and Data Extraction: Case reports of possible NMS secondary to second-generation antipsychotics were selected for review. Reports meeting the Diagnostic and Statistical Manual of Mental Disorders, 4th edition, criteria for NMS were considered. Case reports in which 1 of the 2 major diagnostic criteria was met were also included in the analysis. Furthermore, at least one minor criterion was met. Case reports in which patients received traditional antipsychotics were excluded. Data Synthesis: NMS is a rare and sometimes fatal disease. Several theories exist as to how NMS develops, and an equally large amount of diagnostic criteria are available. However, the majority of available data are based on the first-generation neuroleptics and very few exist with regard to the second-generation antipsychotics. Conclusions: Although there are numerous case reports of NMS occurring secondary to the use of second-generation antipsychotics, the incidence has never been fully elucidated. While the reasons for this remain uncertain, not all cases of second-generation–induced NMS fulfill the diagnostic criteria established for traditional neuroleptics and therefore may not be reported as such.

A Controlled Trial of Extended-Release Guanfacine and Psychostimulants on Executive Function and ADHD

2018 ◽  
Vol 24 (2) ◽  
pp. 318-325 ◽  
Author(s):  
Judy P. M. van Stralen
Keyword(s):  
Executive Function ◽  
Adverse Events ◽  
Extended Release ◽  
Rating Scale ◽  
Controlled Trial ◽  
Severity Of Illness ◽  
P Value ◽  
Serious Adverse Events ◽  
Double Blind ◽  
Stimulant Therapy

Objective: To evaluate the effectiveness of guanfacine extended-release (GXR) versus placebo as adjunct therapy to usual care stimulant therapy in improving executive function in children aged 6 to 12 years diagnosed with ADHD. Method: In this single center, double-blind placebo-controlled crossover trial, subjects continued to take their psychostimulant and were randomly assigned at baseline to receive active treatment or placebo first. Efficacy measures included Behavioural Rating Inventory of Executive Function (BRIEF-P), ADHD Rating Scale IV (ADHD-RS IV), and Clinical Global Impressions of Severity of Illness (CGI-S) and Improvement (CGI-I) scales. Safety measures included adverse events and vital signs. Results: Significant benefits of GXR plus psychostimulant were observed on BRIEF-P ( p value = .0392), ADHD-RS-IV ( p < .0001), CGI-S ( p = .0007), and CGI-I ( p = .003). There were no serious adverse events and no new safety signals. Conclusion: Use of GXR as adjunctive therapy to stimulant therapy significantly improves executive function in children with ADHD.

Decreasing the leakage of continuous femoral nerve catheter fixation using 2-octyl cyanoacrylate glue (Demabond®): A randomized controlled trial

2021 ◽  
Author(s):  
Theerawat Chalacheewa ◽  
Vanlapa Arnuntasupakul ◽  
Lisa Sangkum ◽  
Rungrawan Buachai ◽  
Jiravud Chanvitayapongs
Keyword(s):  
Peripheral Nerve ◽  
Rating Scale ◽  
Controlled Trial ◽  
Insertion Site ◽  
Femoral Nerve ◽  
Numeric Rating Scale ◽  
Catheter Removal ◽  
Cyanoacrylate Glue ◽  
Catheter Dislodgement ◽  
Peripheral Nerve Catheter

Abstract Background: Continuous peripheral nerve catheters (CPNCs) have been used for postoperative pain relief. A common problem encountered with CPNCs is pericatheter leakage, which can lead to dressing adhesive failure. Frequent dressing changes increase the risk of catheter dislodgement and infections. Adhesive glue is effective in securing the peripheral nerve catheter and decreasing leakage around the catheter insertion site. This study aimed to evaluate the incidence of pericatheter leakage with fixation using 2-octyl cyanoacrylate glue (Dermabond®) as compared to sterile strips.Methods: Thirty patients undergoing unilateral total knee arthroplasty (TKA) with continuous femoral nerve catheter for postoperative analgesia were randomized into the catheter fixation with 2-octyl cyanoacrylate glue (Dermabond®) group or the sterile strip group. The primary outcome was the incidence of pericatheter leakage. Secondary outcomes included the frequent of catheter displacement, the difficulty of catheter removal, pain score and patient satisfaction.Results: The incidence of pericatheter leakage at 24 and 48 hours was 0% versus 93% and 0% versus 100% in the Dermabond® and sterile strip groups, respectively (P < 0.001). The incidence of displacement at 24 and 48 hours was 6.7% versus 93.3% and 6.7% versus 100% in the Dermabond® and sterile strip, respectively (P < 0.001). There was no difference in numeric rating scale, difficulty of catheter removal, or satisfaction scores between groups.Conclusion: Catheter fixation with 2-octyl cyanoacrylate glue (Dermabond®) decreased the incidence of pericatheter leakage, as well as catheter displacement, over 48 hours as compared to sterile strip fixation.

scholarly journals 111 Phase 3, Randomized, Double-Blind, Placebo-Controlled Study (P301) Assessing Efficacy and Safety of Extended-Release Viloxazine in Children with ADHD

CNS Spectrums ◽  
2020 ◽  
Vol 25 (2) ◽  
pp. 272-272 ◽  
Author(s):  
Azmi Nasser ◽  
Joseph T. Hull ◽  
Fatima A. Chowdhry ◽  
Toyin Adewole ◽  
Tesfaye Liranso ◽  
...  
Keyword(s):  
Clinical Global Impression ◽  
Extended Release ◽  
Rating Scale ◽  
Controlled Study ◽  
Average Score ◽  
Efficacy And Safety ◽  
Phase 3 ◽  
Double Blind ◽  
T Score ◽  
Total Average

Abstract:Study Objective:SPN-812 (extended-release viloxazine) is a structurally distinct, bicyclic, Serotonin Norepinephrine Modulating Agent (SNMA) in development as a treatment for attention-deficit/hyperactivity disorder (ADHD) in children and adolescents. This Phase 3, randomized, double-blind study (P301) evaluated the efficacy and safety of once-daily SPN-812 at doses of 100 and 200 mg compared to placebo in children ages 6-11yrs with ADHD.Method:Inclusion criteria required subjects have a confirmed Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) ADHD diagnosis, ADHD-Rating Scale-5 (ADHD-RS-5) score ≥28, a Clinical Global Impression-Severity score ≥4, and be free of ADHD medication ≥1 week before randomization. This investigation was conducted at 34 study sites in the United States. Subjects (N=477) were randomized 1:1:1 to placebo:100 mg SPN-812:200 mg SPN-812. The 6-week treatment period included up to 1 week of titration and 5 weeks of maintenance (intent-to-treat population: N=460; placebo=155, 100 mg=147, 200 mg=158). The primary efficacy endpoint was the change from baseline (CFB) at end of study (EOS) in ADHD-RS-5 total score. Key secondary endpoints included Clinical Global Impression-Improvement (CGI-I) scores at EOS, and CFB at EOS in Conners 3-Parent Short Form (Conners 3-PS) Composite T-score and in Weiss Functional Impairment Rating Scale-Parent Version (WFIRS-P) total average score. Safety assessments included adverse events (AEs), laboratory tests, vital signs, physical exams, electrocardiograms, and the Columbia-Suicide Severity Rating Scale.Results:Compared to placebo, a significantly greater improvement in ADHD-RS-5 total score was observed in the 100 mg and 200 mg SPN-812 treatment groups beginning at week 1 (p=0.0004, p=0.0244; respectively) through EOS (p=0.0004, p<0.0001; respectively). Significant improvement at EOS for both 100 mg and 200 mg SPN-812 compared to placebo was also observed in CGI-I score (p=0.0020, p<0.0001; respectively), Connors 3-PS Composite T-score (p=0.0003, p=0.0002; respectively), and in WFIRS-P total average score (p=0.0019, p=0.0002, respectively). The most common (≥5%) treatment-related AEs reported were somnolence, decreased appetite, and headache.Conclusions:In this study, SPN-812 at 100 mg and 200 mg doses met the primary and secondary objectives with statistical significance. AE-related dropouts were ≤5%, indicating SPN-812 treatment was well tolerated.This study is an encore of a poster presentation at the 2019 Annual Meeting of the American Academy of Child and Adolescent Psychiatry (AACAP).Funding Acknowledgements:This research was funded by Supernus Pharmaceuticals, Inc., Rockville, MD.

Electroanalgesia during a carboxytherapy procedure for cellulite: a study protocol for a randomized controlled trial

2020 ◽  
Vol 10 (5) ◽  
pp. 283-290
Author(s):  
Adria Yared Sadala ◽  
Érika Patrícia Rampazo da Silva ◽  
Richard Eloin Liebano
Keyword(s):  
Pain Intensity ◽  
Study Protocol ◽  
Rating Scale ◽  
Controlled Trial ◽  
Numeric Rating Scale ◽  
Secondary Outcome ◽  
Electrical Currents ◽  
Electrical Nerve Stimulation ◽  
Interferential Current ◽  
Clinical Trials Registry

The aim of the present study is to describe a study protocol to compare different types of analgesic electrical currents on pain intensity and sensory comfort during the application of carboxytherapy for the treatment of cellulite. Seventy five women with the presence of moderate and/or severe gluteal cellulite will be randomly allocated into three groups: carboxytherapy plus transcutaneous electrical nerve stimulation, carboxytherapy plus interferential current or carboxytherapy plus Aussie current. Pain intensity, which is the primary outcome, will be measured by a numeric rating scale (0–10). The secondary outcome is sensory comfort, which will be measured using the visual analogue scale (0–10). Trial registration: Brazilian Clinical Trials Registry: ReBEC (RBR-6z82zb) www.ensaiosclinicos.gov.br/rg/RBR-6z82zb/

Studies of Carbamazepine Extended-Release Capsules in Bipolar Disorder

CNS Spectrums ◽  
2005 ◽  
Vol 10 (6) ◽  
pp. 3-5
Author(s):  
Richard H. Weisler
Keyword(s):  
Extended Release ◽  
Rating Scale ◽  
Controlled Trial ◽  
Controlled Study ◽  
Mixed States ◽  
Open Label ◽  
Young Mania ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Bipolar Patients

This discussion reviews data from two 3-week, double-blind, placebo-controlled pivotal trials of carbamazepine extended release capsules (CBZ ERC; SPD417.301 and SPD417.304); pooled results from these trials; data from a 3-week, double-blind, placebo-controlled trial in lithium non-responders or non-tolerators (SPD417.302); and additional supportive data from a 6-month, open-label, extension trial (SPD417.303). In addition, information on a retrospective chart review of 600 adolescent and adult bipolar patients on CBZ ERC is presented.In the first large double-blind, placebo-controlled study assessing CBZ ERC in acute mania, manic and mixed bipolar patients from multiple centers were hospitalized and all medications were discontinued. After reaching a stable baseline 2–5 days later, the patients were randomized to CBZ ERC (n=101; 59% with mixed states) or placebo (n=103; 47% with mixed states) for 3 weeks. An aggressive initial titration schedule was implemented, beginning with 200 mg BID and increased by 200 mg/day until good clinical response was achieved or the patient could not tolerate the dosage. Many patients were taking 1,200–1,600 mg/day by the end of week 1. Efficacy was assessed using the Young Mania Rating Scale (YMRS). The Clinical Global Impressions (CGI) scale and the Hamilton Rating Scale for Depression (HAM-D) were also followed.

Second-generation antipsychotics: are their similarities greater than their differences?

2003 ◽  
Vol 18 (S2) ◽  
pp. 38s-45s
Author(s):  
W. Wolfgang Fleischhacker
Keyword(s):  
Comparative Studies ◽  
Second Generation ◽  
Rating Scale ◽  
Scientific Evidence ◽  
Treatment Decision ◽  
Antipsychotic Agent ◽  
Generation Agent ◽  
Second Generation Antipsychotics ◽  
Psychiatric Rating ◽  
Psychiatric Rating Scale

AbstractThe move towards the use of second-generation antipsychotics for the treatment of schizophrenia has provoked much discussion over how to differentiate between the various second-generation agents available on the market. The aim of this review is to provide information that may help clinicians in the decision-making process. The results of comparative studies on general efficacy measures (such as the Positive and Negative Syndrome Scale [PANSS] and the Brief Psychiatric Rating Scale [BPRS]) and comparative studies on cognition do not clearly favour one second-generation agent over another. However, some differences between second-generation agents have become apparent from studies which have examined specific symptoms such as hostility, suicidal ideation and depression/anxiety. There are also differences between second-generation agents with regard to specific aspects of tolerability. For example, in a number of studies olanzapine is associated with fewer extrapyramidal symptoms (EPS) than risperidone, but treatment with risperidone or amisulpride is associated with less weight gain and somnolence. Some studies have investigated the results of switching patients from one antipsychotic agent to another. They have generally reported a successful switch to a second-generation agent.Overall, there is not enough scientific evidence available to clearly favour one second-generation antipsychotic agent over another in terms of general efficacy or tolerability. Therefore, clinicians must make an individualised treatment decision, and select the most appropriate antipsychotic agent for each patient.

scholarly journals 112 A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study (P302): Efficacy and Safety of Extended-Release Viloxazine in Adolescents with ADHD

CNS Spectrums ◽  
2020 ◽  
Vol 25 (2) ◽  
pp. 272-273 ◽  
Author(s):  
Azmi Nasser ◽  
Joseph T. Hull ◽  
Fatima A. Chowdhry ◽  
Toyin Adewole ◽  
Tesfaye Liranso ◽  
...  
Keyword(s):  
Clinical Global Impression ◽  
Extended Release ◽  
Rating Scale ◽  
Controlled Study ◽  
Average Score ◽  
Efficacy And Safety ◽  
Phase 3 ◽  
Double Blind ◽  
T Score ◽  
Total Average

Abstract:Study Objective:SPN-812 (extended-release viloxazine) is a structurally distinct, bicyclic, Serotonin Norepinephrine Modulating Agent (SNMA) in development as a treatment for attention-deficit/hyperactivity disorder (ADHD) in children and adolescents. This Phase 3, randomized, double-blind study (P302) evaluated the efficacy and safety of once-daily SPN-812 at doses of 200 and 400 mg compared to placebo in adolescents ages 12-17yrs with ADHD.Method:Inclusion criteria required subjects have a confirmed Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) ADHD diagnosis, ADHD-Rating Scale-5 (ADHD-RS-5) score ≥28, Clinical Global Impression-Severity score ≥4, and be free of ADHD medication ≥1 week before randomization. This investigation was conducted at 34 study sites in the United States. Subjects (N=310) were randomized 1:1:1 to placebo:200 mg SPN-812:400 mg SPN-812. The treatment period included up to 1 week of titration and 5 weeks of maintenance (intent-to-treat population: N=301; placebo=104, 200 mg=94, 400 mg=103). The primary efficacy endpoint was change from baseline (CFB) at end of study (EOS) in ADHD-RS-5 total score. Key secondary endpoints included Clinical Global Impression-Improvement (CGI-I) score at EOS, and CFB at EOS in Conners 3-Parent Short Form (Conners 3-PS) Composite T-score and Weiss Functional Impairment Rating Scale-Parent Form (WFIRS-P) total average score. Safety assessments included adverse events (AEs), laboratory tests, vital signs, physical exams, electrocardiograms, and the Columbia-Suicide Severity Rating Scale.Results:Compared to placebo, a significantly greater improvement in ADHD-RS-5 total score was observed in the 200 mg and 400 mg SPN-812 treatment group at EOS (p=0.0232, p=0.0091; respectively). Significant improvement in CGI-I score at EOS for both 200 mg and 400 mg SPN-812 compared to placebo was also observed (p=0.0042, p=0.0003; respectively). No significant change was observed at either dose compared to placebo in the Conners 3-PS Composite T-score (p=0.6854, p=0.0518; respectively), or the WFIRS-P total average score (p=0.2062, p=0.0519; respectively). The most common (≥5%) treatment-related AEs were somnolence, decreased appetite, fatigue, headache, and nausea.Conclusions:In this study, SPN-812 met the primary objective for both the 200 and 400 mg doses, and a key secondary objective (CGI-I) for both the 200 and 400 mg doses. AE-related dropouts were ≤5%, indicating SPN-812 treatment was well tolerated.This study is an encore of a poster presentation at the 2019 Annual Meeting of the American Academy of Child and Adolescent Psychiatry (AACAP).Funding Acknowledgements:This research was funded by Supernus Pharmaceuticals, Inc., Rockville, MD.

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