scholarly journals Off-label use of ketamine for treatment-resistant depression in clinical practice: European perspective

2019 ◽  
Vol 215 (2) ◽  
pp. 447-448 ◽  
Author(s):  
Álvaro López-Díaz ◽  
Manuel Murillo-Izquierdo ◽  
Elisa Moreno-Mellado
Keyword(s):  
Clinical Practice ◽  
Public Healthcare ◽  
Evidence Based ◽  
European Perspective ◽  
Treatment Resistant Depression ◽  
Off Label Use ◽  
Treatment Resistant ◽  
Off Label ◽  
Resistant Depression ◽  
Label Use

SummaryKetamine therapy for treatment-resistant depression in European national health systems may only be considered after attempting all evidence-based antidepressant strategies outlined in clinical guidelines. This paper seeks to explain the ethical, regulatory and procedural framework for the off-label use of ketamine for treatment-resistant depression within a public healthcare system.Declaration of interestNone.

scholarly journals Off Label Use of Suboxone for Treatment Resistant Depression

2016 ◽  
Vol 2 (1) ◽  
Author(s):  
George Kamajian ◽  
Robert Cable ◽  
Jonathan Greco ◽  
Brady Laughlin ◽  
Tanya deGroot
Keyword(s):  
Treatment Resistant Depression ◽  
Off Label Use ◽  
Treatment Resistant ◽  
Off Label ◽  
Resistant Depression ◽  
Label Use

scholarly journals Esketamine for treatment resistant depression: a trick of smoke and mirrors?

2019 ◽  
Vol 29 ◽  
Author(s):  
C. Gastaldon ◽  
D. Papola ◽  
G. Ostuzzi ◽  
C. Barbui
Keyword(s):  
Clinical Practice ◽  
Severe Depression ◽  
Practice Research ◽  
Treatment Resistant Depression ◽  
Treatment Resistant ◽  
Off Label ◽  
The Us ◽  
The Usa ◽  
Resistant Depression ◽  
Spray Formulation

Abstract In March 2019, the US Food and Drug Administration (FDA) approved a nasal spray formulation of esketamine for the treatment of resistant depression in adults. Esketamine is the S-enantiomer of ketamine, an FDA-approved anaesthetic, known to cause dissociation and, occasionally, hallucinations. While ketamine has not been approved for depression in the USA or in any other country, it has been used off-label in cases of severe depression. This commentary critically reviewed the evidence on esketamine submitted to the FDA, aiming to draw implications for clinical practice, research and regulatory science.

scholarly journals Epidemiology and current treatment patterns of treatment-resistant depression in Scotland: a CPRD study

BJPsych Open ◽  
2021 ◽  
Vol 7 (S1) ◽  
pp. S334-S334
Author(s):  
Timothy Ming ◽  
Tom Denee ◽  
Gemma Scott ◽  
Joachim Morrens ◽  
Christopher Weatherburn
Keyword(s):  
Clinical Practice ◽  
Incidence Rates ◽  
Practice Research ◽  
Clinical Practice Research Datalink ◽  
Treatment Resistant Depression ◽  
Augmentation Therapy ◽  
Treatment Resistant ◽  
First Line ◽  
Resistant Depression

AimsTo assess the incidence and treatments currently used in clinical practice for the treatment of treatment-resistant depression (TRD) in Scotland.BackgroundPatients with major depressive disorder (MDD) who have not responded to at least two successive antidepressant (AD) treatments in a single episode are described as having Treatment-Resistant Depression (TRD). Epidemiological data on TRD in Scotland is lacking. Furthermore, there is no data to our knowledge on therapies prescribed in Scottish clinical practice to treat TRD.MethodA retrospective, longitudinal cohort study was conducted using Clinical Practice Research Datalink (CPRD) medical records. Adult patients were indexed on AD prescription, requiring MDD diagnosis within 90 days, from Jan 2011-May 2018 with 360-day baseline and 180-day minimum follow-up periods. Failure of ≥2 adequate oral AD regimens following indexing constituted TRD classification. Incidence rates of MDD and TRD (within the MDD cohort) and treatment lines following TRD classification were derived.ResultThe analysis included 20,059 patients with MDD (mean age 44 years, 63% female, median follow-up 59 months); 1,374 (6.8%) were classified as TRD. Median time-to-TRD classification was 25 months. The incidence rate of MDD was 15.9 per 1,000 patient-years and for TRD was 14.7 per 1,000 MDD-patient-years. For all first four post-TRD treatment lines, SSRI monotherapy was the most commonly prescribed therapy, followed by combination (dual/triple) therapy and augmentation therapy (at least one oral AD supplemented with lithium, an antipsychotic or an anticonvulsant therapy). At first-line of TRD treatment, 1,050 (76.4%) patients received monotherapy AD, 212 (15.4%) received combination AD therapy and 112 (8.2%) received augmentation therapy. The most common monotherapy treatments at first-line TRD were sertraline (15.6%), mirtazapine (13.8%), fluoxetine (12.2%) and venlafaxine (11.6%). Among combination therapies, mirtazapine, venlafaxine, sertraline and amitriptyline were frequently used. Among the TRD and MDD cohort, no somatic treatments were coded in CPRD, although the use of these treatments was likely underestimated.ConclusionMonotherapy AD treatment was the most common therapy type for all four post-TRD treatment lines. These data support the need for new treatments that can achieve and maintain therapeutic response, and avoid continuous cycling through similar AD therapies.This study was sponsored by Janssen Cilag Ltd.

scholarly journals Pharmacological Augmentation in Unipolar Depression: A Guide to the Guidelines

2020 ◽  
Vol 23 (9) ◽  
pp. 587-625 ◽  
Author(s):  
Rachael W Taylor ◽  
Lindsey Marwood ◽  
Emanuella Oprea ◽  
Valeria DeAngel ◽  
Sarah Mather ◽  
...  
Keyword(s):  
Treatment Guidelines ◽  
Evidence Based ◽  
Treatment Resistant Depression ◽  
Treatment Resistant ◽  
Comprehensive Overview ◽  
Objective Evidence ◽  
Resistant Depression ◽  
Evidence Based Care ◽  
Guidelines For Depression

Abstract Background Pharmacological augmentation is a recommended strategy for patients with treatment-resistant depression. A range of guidelines provide advice on treatment selection, prescription, monitoring and discontinuation, but variation in the content and quality of guidelines may limit the provision of objective, evidence-based care. This is of importance given the side effect burden and poorer long-term outcomes associated with polypharmacy and treatment-resistant depression. This review provides a definitive overview of pharmacological augmentation recommendations by assessing the quality of guidelines for depression and comparing the recommendations made. Methods A systematic literature search identified current treatment guidelines for depression published in English. Guidelines were quality assessed using the Appraisal of Guidelines for Research and Evaluation II tool. Data relating to the prescription of pharmacological augmenters were extracted from those developed with sufficient rigor, and the included recommendations compared. Results Total of 1696 records were identified, 19 guidelines were assessed for quality, and 10 were included. Guidelines differed in their quality, the stage at which augmentation was recommended, the agents included, and the evidence base cited. Lithium and atypical antipsychotics were recommended by all 10, though the specific advice was not consistent. Of the 15 augmenters identified, no others were universally recommended. Conclusions This review provides a comprehensive overview of current pharmacological augmentation recommendations for major depression and will support clinicians in selecting appropriate treatment guidance. Although some variation can be accounted for by date of guideline publication, and limited evidence from clinical trials, there is a clear need for greater consistency across guidelines to ensure patients receive consistent evidence-based care.

scholarly journals Apixaban for Stroke Prevention in Atrial Fibrillation: Why are Event Rates Higher in Clinical Practice than in Randomized Trials?—A Systematic Review

2020 ◽  
Vol 120 (09) ◽  
pp. 1323-1329 ◽  
Author(s):  
Tim A. C. de Vries ◽  
Jack Hirsh ◽  
Ke Xu ◽  
Imaad Mallick ◽  
Vinai C. Bhagirath ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Practice ◽  
Thromboembolic Event ◽  
Meta Analysis ◽  
Patient Characteristics ◽  
Thromboembolic Events ◽  
Off Label Use ◽  
Off Label ◽  
Event Rates ◽  
Label Use

Abstract Background Recent reports suggest an important contribution from frequent off-label use of apixaban 2.5 mg twice daily to the higher rates of thromboembolic events observed in observational studies (OSs) relative to in randomized controlled trials (RCTs), and consequently, advocate against such use in all patients. Objectives To examine factors contributing to the higher thromboembolic event rates, we estimated the prevalence of off-label use in contemporary practice, and compared patient characteristics and rates of stroke/systemic embolism, major bleeding, and mortality by apixaban dose and by study design in a systematic review and meta-analysis. Results and Discussion We identified 18 OSs and 2 RCTs that included 155,228 and 11,928 patients, respectively. Patients in OSs more often received apixaban 2.5 mg twice daily (31.3% vs. 5.1%), were older (mean age 73.8 vs. 69.8 years), and had higher CHA2DS2-VASc scores (mean 3.6 vs. 2.9) versus those in RCTs. We observed a consistent pattern of higher rates of thromboembolic events, bleeding, and mortality in patients treated with 2.5 versus 5 mg twice daily apixaban in both OSs and RCTs. Conclusion The higher risk profiles of patients in OSs versus RCTs, and higher rates of both bleeding and mortality not attributable to thromboembolism in patients treated with apixaban 2.5 versus 5 mg twice daily suggest that differences in patient characteristics are additional important contributors to the higher than expected thromboembolic event rates in clinical practice.

Efficacy and Safety of SGLT2 Inhibitors in Type 1 Diabetes After the Introduction of an Off-Label Use Protocol for Clinical Practice

2020 ◽  
Vol 22 (3) ◽  
pp. 208-215 ◽  
Author(s):  
Ane Bayona Cebada ◽  
Lía Nattero-Chávez ◽  
Sara Alonso Díaz ◽  
Héctor F. Escobar-Morreale ◽  
Manuel Luque-Ramírez
Keyword(s):  
Type 1 Diabetes ◽  
Clinical Practice ◽  
Sglt2 Inhibitors ◽  
Efficacy And Safety ◽  
Off Label Use ◽  
Off Label ◽  
Label Use

Treatment-resistant depression: From pseudo-resistance to full resistance

2011 ◽  
Vol 26 (S2) ◽  
pp. 638-638
Author(s):  
E. Millet ◽  
R. Icick ◽  
J.P. Lépine
Keyword(s):  
Clinical Practice ◽  
Substance Dependence ◽  
Clinical Sample ◽  
Cognitive Status ◽  
University Hospital ◽  
Treatment Resistant Depression ◽  
Treatment Resistant ◽  
Resistant Depression ◽  
Number Of Publications ◽  
Larger Sample

IntroductionTreatment-resistant depression (TRD) has been a controversial issue for more than 35 years. Despite a large number of publications, clinicians and researchers still know few about the prevalence of TRD since no staging method has been validated.ObjectivesWe sought to assess similarities and differences between the 4 TRD-staging methods published to date and assess TRD prevalence in a clinical sample. We also wanted to look for clinical factors associated with TRD.MethodsWe conducted a clinical study in a psychiatric unit of a university hospital. We designed a hetero-questionnaire to stage TRD according to the 4 methods. Psychiatric diagnosis, depression severity and cognitive status were assessed using standardized tools. Patients were not included in the study if they suffer from schizophrenia, bipolar disorder, current substance dependence or major cognitive impairment.ResultsWe recruited 37 inpatients. Twenty-four had received an inadequate treatment, four had not responded after one adequate antidepressant trial and 9 after two trials. Only 7 were resistant according to the 4 staging methods, which showed several differences. The Massachussetts General Hospital (MGH) method appeared as the most specific and easy-to-use. Complete TRD seemed much less frequent than pseudo-resistance and relative resistance with untreated comorbidity. Chronic depression and comorbidity were frequent in the TRD subgroup.ConclusionThe concept of “difficult-to-treat” depression might be more appropriate for clinical practice than TRD. The MGH tool seems to fit best to clinical practice. Further research is needed to confirm these descriptive findings in a larger sample.

scholarly journals Use of 30-Hz Accelerated iTBS in Drug-Resistant Unipolar and Bipolar Depression in a Public Healthcare Setting: A Case Series

2022 ◽  
Vol 12 ◽  
Author(s):  
Filippo Cantù ◽  
Giandomenico Schiena ◽  
Domenico Sciortino ◽  
Lorena Di Consoli ◽  
Giuseppe Delvecchio ◽  
...  
Keyword(s):  
Rating Scale ◽  
Bipolar Depression ◽  
Case Series ◽  
Healthcare Setting ◽  
Public Healthcare ◽  
Treatment Resistant Depression ◽  
Treatment Resistant ◽  
Resistant Depression ◽  
Depressive Episodes ◽  
Hamilton Rating Scale

Background: Depressive episodes, especially when resistant to pharmacotherapy, are a hard challenge to face for clinicians and a leading cause of disability worldwide. Neuromodulation has emerged as a potential therapeutic option for treatment-resistant depression (TRD), in particular transcranial magnetic stimulation (TMS). In this article, we present a case series of six patients who received TMS with an accelerated intermittent theta-burst stimulation (iTBS) protocol in a public healthcare setting.Methods: We enrolled a total number of six participants, affected by a treatment-resistant depressive episode, in either Major Depressive Disorder (MDD) or Bipolar Disorder (BD). Patients underwent an accelerated iTBS protocol, targeted to the left dorsolateral prefrontal cortex (DLPFC), 3-week-long, with a total of 6 days of overall stimulation. On each stimulation day, the participants received 3 iTBS sessions, with a 15-min pause between them. Patients were assessed by the Hamilton Rating Scale for Depression (HAM-D), the Montgomery-Asberg Depression Rating Scale (MADRS), the Hamilton Rating Scale for Anxiety (HAM-A), and the Mania Rating Scale (MRS). At baseline (T0), at the end of the second week (T1), and at the end of the cycle of stimulation (T2).Results: The rANOVA (repeated Analysis of Variance) statistics showed no significant effect of time on the rating scale scores, with a slight decrease in MADRS scores and a very slight increase in HAM-A and HAM-D scores. No manic symptoms emerged during the entire protocol.Conclusions: Although accelerated iTBS might be considered a less time-consuming strategy for TMS administration, useful in a public healthcare setting, our results in a real-word six-patient population with TRD did not show a significant effect. Further studies on wider samples are needed to fully elucidate the potential of accelerated iTBS protocols in treatment-resistant depression.

scholarly journals Contrasting evidence to reimbursement reality for off-label use (OLU) of drug treatments in cancer care: rationale and design of the CEIT-OLU project

ESMO Open ◽  
2019 ◽  
Vol 4 (6) ◽  
pp. e000596
Author(s):  
Amanda Katherina Herbrand ◽  
Andreas Michael Schmitt ◽  
Matthias Briel ◽  
Stefan Diem ◽  
Hannah Ewald ◽  
...  
Keyword(s):  
Cancer Care ◽  
Clinical Evidence ◽  
Patient Characteristics ◽  
Evidence Based ◽  
Cancer Drugs ◽  
Off Label Use ◽  
Level Of Evidence ◽  
Treatment Benefit ◽  
Off Label ◽  
Label Use

BackgroundOff-label use (OLU) of a drug reflects a perceived unmet medical need, which is common in oncology. Cancer drugs are often highly expensive and their reimbursement is a challenge for many healthcare systems. OLU is frequently regulated by reimbursement restrictions. For evidence-based healthcare, treatment ought to be reimbursed if there is sufficient clinical evidence for treatment benefit independently of patient factors not related to the treatment indication. However, little is known about the reality of OLU reimbursement and its association with the underlying clinical evidence. Here, we aim to investigate the relationship of reimbursement decisions with the underlying clinical evidence.Methods/ designWe will extract patient characteristics and details on treatment and reimbursement of cancer drugs from over 3000 patients treated in three Swiss hospitals. We will systematically search for clinical trial evidence on benefits associated with OLU in the most common indications. We will describe the prevalence of OLU in Switzerland and its reimbursement in cancer care, and use multivariable logistic regression techniques to investigate the association of approval/rejection of a reimbursement requests to the evidence on treatment effects and to further factors, including type of drug, molecular predictive markers and the health insurer.DiscussionOur study will provide a systematic overview and assessment of OLU and its reimbursement reality in Switzerland. We may provide a better understanding of the access to cancer care that is regulated by health insurers and we hope to identify factors that determine the level of evidence-based cancer care in a highly diverse western healthcare system.

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