Cariprazine in Bipolar Depression and Mania: State of the Art

2018 ◽  
Vol 17 (10) ◽  
pp. 723-727 ◽  
Author(s):  
Marianna Mazza ◽  
Giuseppe Marano ◽  
Gianandrea Traversi ◽  
Valentina Carocci ◽  
Benedetta Romano ◽  
...  
Keyword(s):  
Bipolar Disorder ◽  
Clinical Trials ◽  
Randomized Clinical Trials ◽  
State Of The Art ◽  
Bipolar Depression ◽  
Therapeutic Option ◽  
Pharmacological Profile ◽  
High Affinity ◽  
Bipolar Mania ◽  
Additional Option

Background & Objective: Cariprazine is a piprazine derivative approved by the FDA in 2015 for the treatment of schizophrenia and bipolar manic or mixed episodes in adults. High affinity for D3 dopamine receptors and observed actions on 5HT1A, 5HT2A and alpha 1B receptors differentiate it pharmacologically from other antipsychotics. This review is a comprehensive and thorough summary of the most important findings on cariprazine use in bipolar mania and depression. Pharmacokinetics, pharmacogenetics, tolerability and safety adverse effects are discussed in this paper. Results & Conclusion: Moreover, the results from pivotal clinical trials are presented. Cariprazine represents an additional option for clinicians to treat patients with bipolar disorder. It shows a unique pharmacological profile and has demonstrated in randomized clinical trials efficacy and general tolerability compared to placebo in bipolar mania and seem to be a promising therapeutic option for bipolar depression.

scholarly journals Opportunities for selective reporting of harms in randomized clinical trials: Selection criteria for nonsystematic adverse events

2019 ◽  
Author(s):  
Evan Mayo-Wilson ◽  
Nicole Fusco ◽  
Hwanhee Hong ◽  
Tianjing Li ◽  
Joseph K. Canner ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Adverse Events ◽  
Selection Criteria ◽  
Randomized Clinical Trials ◽  
Bipolar Depression ◽  
Selective Reporting ◽  
Journal Articles ◽  
Multiple Sources ◽  
Study Results ◽  
Meta Analyses

Abstract Background: Adverse events (AEs) in randomized clinical trials may be reported in multiple sources. Different methods for reporting adverse events across trials, or across sources for a single trial, may produce inconsistent and confusing information about the adverse events associated with interventions Methods: We sought to compare the methods authors use to decide which AEs to include in a particular source (i.e., “selection criteria”) and to determine how selection criteria could impact the AEs reported. We compared sources (e.g., journal articles, clinical study reports [CSRs]) of trials for two drug-indications: gabapentin for neuropathic pain and quetiapine for bipolar depression. We identified selection criteria and assessed how criteria affected AE reporting. Results: We identified 21 gabapentin trials and 7 quetiapine trials. All CSRs (6 gabapentin, 2 quetiapine) reported all AEs without applying selection criteria; by comparison, no other source reported all AEs, and 15/68 (22%) gabapentin sources and 19/48 (40%) quetiapine sources reported using selection criteria. Selection criteria greatly affected the number of AEs that would be reported. For example, 67/316 (21%) AEs in one quetiapine trial met the criterion “occurring in ≥2% of participants in any treatment group,” while only 5/316 (2%) AEs met the criterion, “occurring in ≥10% of quetiapine-treated patients and twice as frequent in the quetiapine group as the placebo group.” Conclusions: Selection criteria for reporting AEs vary across trials and across sources for individual trials. If investigators do not pre-specify selection criteria, they might “cherry-pick” AEs based on study results. Even if investigators pre-specify selection criteria, selective reporting of AEs will produce biased meta-analyses and clinical practice guidelines. Data about all AEs identified in clinical trials should be publicly available; however, sharing data will not solve all the problems we identified in this study. Keywords: Harms, adverse events, clinical trials, reporting bias, selective outcome reporting, data sharing, trial registration

scholarly journals Acupuncture as a therapeutic option for tension-type headache: A Systematic Review

2021 ◽  
Author(s):  
Camila Puton, Caio de Almeida Lellis ◽  
Caio Reis Borges ◽  
Giovanna Garcia de Oliveira
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Relaxation Training ◽  
Randomized Clinical Trials ◽  
Therapeutic Option ◽  
Control Process ◽  
Tension Headache ◽  
Primary Headache ◽  
Tension Type Headache ◽  
Type Headache

Introduction: Tension headache (TTS), the most common type of primary headache, is characterized by tightness pain, typically bilateral, lasting hours or days, significantly impairing daily activities. Objectives: To review the literature on the use of acupuncture in the management of TTS, evaluating its safety and efficacy. Design and setting: A systematic review conducted at the Pontifical Catholic University of Goiás. Methods: A systematic literature review was performed in the PubMed, EMBASE and Virtual Health Library databases, with the terms: “Tension-Type Headache AND Acupuncture”. Randomized studies and clinical trials published in the last 10 years were selected. Results: Two studies, one clinical trial and one randomized trial, concluded that combining acupuncture with another therapy involving movement, such as stretching, physical therapy techniques, or relaxation training, led to reduced pain intensity and improved quality of life in patients with TTS. In contrast, other randomized clinical trials concluded that relaxation training decreased the intensity, frequency of attacks, and adjunctive symptoms of headache (sleep and vitality) more than acupuncture. Finally, acupuncture was compared with the simulated control process in the prevention of TTS, but there were no statistically significant differences between the two groups evaluated. Conclusion: The literature indicated that the combination of acupuncture with other therapeutic options was safe and effective in the management and prevention of TTS. Studies with greater scientific rigor should be conducted for a better understanding of this therapeutic option.

Novel Neurological and Anti-epileptic Drug of Combined Valproic acid and Topiramate (TopVal).

2021 ◽  
Author(s):  
Mina Kelleni
Keyword(s):  
Valproic Acid ◽  
Clinical Trials ◽  
Safety Profile ◽  
Randomized Clinical Trials ◽  
Refractory Epilepsy ◽  
Neurological Diseases ◽  
Therapeutic Option ◽  
Anti Epileptic Drug

In this communication we demonstrate the development of a novel neurological compound of combined valproic acid and topiramate (TopVal) which might offer a potential therapeutic option for epilepsy, refractory epilepsy as well as other neurological diseases currently managed by either drug. A lower administered dose might help to achieve a higher safety profile when enrolled for randomized clinical trials against either drug.

Stability and treatment outcome of distinct classes of mania

2008 ◽  
Vol 23 (5) ◽  
pp. 360-367 ◽  
Author(s):  
Inge van Rossum ◽  
Josep Maria Haro ◽  
Diederik Tenback ◽  
Maarten Boomsma ◽  
Iris Goetz ◽  
...  
Keyword(s):  
Bipolar Disorder ◽  
Clinical Trials ◽  
Treatment Outcome ◽  
Randomized Clinical Trials ◽  
Differential Treatment ◽  
Social Outcomes ◽  
Acute Mania ◽  
Regression Analyses ◽  
Multilevel Regression ◽  
Class Differences

AbstractBackgroundPsychopathological heterogeneity in manic syndromes may in part reflect underlying latent classes with characteristic outcome patterns. Differential treatment course and outcome after 12 weeks of treatment were examined for three distinct classes of patients with acute mania in bipolar disorder.Subjects and methodsThree thousand four hundred and twenty-five patients with acute mania were divided into three distinct mania classes: ‘Typical’, ‘Psychotic’ and ‘Dual’ (i.e. comorbid substance use) mania. Persistence of class differences and social outcomes were examined, using multilevel regression analyses and odds ratios.ResultsThe three classes showed substantial stability post-baseline in the pattern of associations with class-characteristic variables. Psychotic and Dual mania predicted poorer outcome in terms of psychosis comorbidity and overall bipolar and mania severity, while Dual mania additionally predicted poorer outcome of alcohol and substance abuse. Worse social outcomes were observed for both Dual and Psychotic mania.ConclusionThe identified distinct classes are stable and associated with differential treatment outcome. Overall, Dual and Psychotic mania show less favourable outcomes compared to Typical mania. These findings additionally give rise to concern on the generalisability of randomized clinical trials RCTs.

Randomized clinical trials in US hospices: challenges and the current state of the art

2015 ◽  
Vol 5 (11) ◽  
pp. 839-846 ◽  
Author(s):  
Robin L Kruse ◽  
Lauren Ashley Gage ◽  
Karla T Washington ◽  
Debra Parker Oliver
Keyword(s):  
Clinical Trials ◽  
Randomized Clinical Trials ◽  
State Of The Art ◽  
Current State

scholarly journals The Role of Niacin in Cardiovascular Disease Prevention: A Systematic Review and Meta-analysis

2019 ◽  
Vol 29 (Supplement_4) ◽  
Author(s):  
E D’Andrea ◽  
S Hey ◽  
C L Ramirez ◽  
A Kesselheim
Keyword(s):  
Systematic Review ◽  
Cardiovascular Disease ◽  
Clinical Trials ◽  
Secondary Prevention ◽  
Randomized Clinical Trials ◽  
Therapeutic Option ◽  
Meta Analysis ◽  
Long Term Outcome ◽  
Coronary Syndrome ◽  
Cardiovascular Secondary Prevention

Abstract Background Niacin remains a therapeutic option for patients with cardiovascular disease, but recent studies have called into question the effectiveness of other HDL-C-raising drugs. We evaluated the evidence supporting current FDA-approved uses of niacin in cardiovascular prevention settings. Methods The systematic review included clinical trials involving niacin as a treatment for cardiovascular disease. The meta-analysis included randomized clinical trials reporting niacin’s effect on at least one long-term outcome: cardiovascular disease, coronary heart disease mortality, acute coronary syndrome, stroke, revascularization, major adverse cardiac events (MACE). Databases were searched up to October 2017. Study-level data were extracted and inverse-variance weighted methods were used to produce pooled risk ratios using random-effects models for between-study heterogeneity. Meta-regression analysis was used to assess the association between change in HDL-C and the log risk ratio of the pooled results. Results Out of 119 clinical trials, 17 documented niacin’s effect on at least one cardiovascular disease outcome. The meta-analysis covered 35,760 patients with history of cardiovascular disease or dyslipidemia. Cumulative evidence found no preventive effect of niacin on cardiovascular outcomes in secondary prevention. Stratified meta-analysis showed an association between niacin monotherapy and reduction of some cardiovascular events (acute coronary events, RR 0.74, 95%CI 0.58-0.96; stroke, RR 0.74, 95%CI 0.59-0.94; revascularization, RR 0.51, 95%CI 0.37-0.72). These results were mainly driven by two trials conducted in the 1970s and 1980s. Conclusions Niacin might have some use in lipid control for secondary prevention as monotherapy, perhaps in patients intolerant to statins, but evidence is from older studies on a population potentially not representative of current-day patients. Key messages Niacin might have some use for cardiovascular secondary prevention in patients intolerant to statins, but evidence is from older studies on a population not representative of current-day patients. The FDA has to review the approved indications for Niacin in cardiovascular secondary prevention.

scholarly journals Cannabinoids in the Treatment of Parkinson’s Disease

2017 ◽  
Vol 01 (04) ◽  
pp. E307-E311 ◽  
Author(s):  
Florin Gandor ◽  
Georg Ebersbach
Keyword(s):  
Parkinson’S Disease ◽  
Parkinson's Disease ◽  
Clinical Trials ◽  
Randomized Clinical Trials ◽  
Single Case ◽  
Case Reports ◽  
Therapeutic Option ◽  
Case Series ◽  
Idiopathic Parkinson’S Disease ◽  
Idiopathic Parkinson's Disease

AbstractDue to the changing legal status of medical cannabis and derivatives in numerous countries, this therapeutic option has moved into the field of public debate. Neurologists treating patients with idiopathic Parkinson’s disease are increasingly confronted with questions regarding cannabis as a treatment alternative, especially for levodopa-resistant Parkinson’s symptoms. A number of single case reports and case series suggested improvement of Parkinsonian symptoms after cannabinoid intake, but the small number of available randomized clinical trials failed to reproduce the extent of these findings. Only one trial found a reduction of levodopa-induced dyskinesia with cannabinoid treatment, the remaining three trials showed no effect on Parkinsonian symptoms. This article gives an overview on the effects of cannabis, and reviews experimental and clinical trials studying the effects of cannabinoids in idiopathic Parkinson’s disease.

scholarly journals The Role of Implantable Cardioverter Defibrillators in Ischemic and Non-Ischemic Cardiomyopathy and Effect on Mortality and Sudden Death

2016 ◽  
Vol 23 (1) ◽  
pp. 12
Author(s):  
Shervin Eshaghian
Keyword(s):  
Clinical Trials ◽  
High Risk ◽  
Ischemic Cardiomyopathy ◽  
Randomized Clinical Trials ◽  
Therapeutic Option ◽  
Implantable Cardioverter Defibrillators ◽  
High Risk Patients ◽  
Risk Patients ◽  
Life Threatening ◽  
Cardioverter Defibrillators

Implantable Cardioverter Defibrillators (ICDs) have evolved from a treatment of last resort to the current and rapidly growing use as a first line therapeutic option. Early clinical trials captured what had only been apparent in observational studies that subsequently paved the way for the utilization of ICDs as secondary prevention in patients who had survived life-threatening arrhythmias. As a result, these randomized clinical trials exhibited a benefit with ICD only in high-risk patients with ischemic cardiomyopathy. However, recent studies have been able to demonstrate a significant role for primary prevention in selected high-risk patients with non-ischemic cardiomyopathy.

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