Intranasal esketamine: A novel drug for treatment-resistant depression

2020 ◽  
Vol 77 (17) ◽  
pp. 1382-1388
Author(s):  
Farah Khorassani ◽  
Om Talreja
Keyword(s):  
Blood Pressure ◽  
English Language ◽  
Severe Depression ◽  
Antidepressant Therapy ◽  
Inadequate Response ◽  
Treatment Resistant Depression ◽  
Treatment Resistant ◽  
Included Review ◽  
Resistant Depression ◽  
Novel Drug

Abstract Purpose To review the efficacy, safety, and place in therapy of intranasal esketamine, a treatment modality for treatment-resistant depression. Summary An electronic literature search of PubMed, MEDLINE, and the ClinicalTrials.gov and Food and Drug Administration (FDA) websites covering the period April 2015 through June 2020 was performed using the following search terms: esketamine, intranasal esketamine, depression, and treatment-resistant depression. Other resources included review articles and the manufacturer’s product labeling. All relevant English-language articles and reports on clinical trials conducted in humans were included. Esketamine (Spravato, Janssen Pharmaceuticals) is an intranasal antidepressant approved by FDA for management of treatment-resistant depression (TRD) in patients with inadequate response to traditional antidepressant therapy. Esketamine is self-administered under the supervision of a healthcare provider and is used as an adjunct to oral antidepressant therapy. Patients are supervised for 2 hours after self-administering the medication to monitor for sedation, dizziness, dissociation reactions, and increased blood pressure. Esketamine has a favorable risk-to-benefit profile, with demonstrated efficacy in reducing depressive symptoms more rapidly than monotherapy with traditional oral antidepressants. Reported adverse effects include sedation, dizziness, dissociation reactions, and blood pressure elevations, but these effects are primarily confined to the 2-hour postdose monitoring window. Conclusion Patients with moderate to severe depression who are not sufficiently responsive to traditional strategies for managing TRD may benefit from adjunctive esketamine therapy.

Ketamine: Safe and Effective Treatment for Severe Depression

2021 ◽  
pp. 107839032110330
Author(s):  
Thomas Bradley Koss
Keyword(s):  
Low Dose ◽  
Alternative Therapy ◽  
Severe Depression ◽  
Infusion Therapy ◽  
Depression Treatment ◽  
Educational Video ◽  
Treatment Resistant Depression ◽  
Treatment Resistant ◽  
Safety And Efficacy ◽  
Resistant Depression

OBJECTIVE Depression resistant to standard treatment is devastating to an individual’s quality of life. Ketamine offers a safe and effective alternative to standard depression treatment, but many patients and providers are often unaware of this option. The American Association of Nurse Anesthetists and the American Psychiatric Nurses Association partnered in developing a collaborative approach to providing ketamine infusion therapy for psychiatric disorders. The purpose of this project was to disseminate information through an educational video about the safety and efficacy of outpatient low-dose ketamine infusions as an alternative therapy for treatment-resistant depression. METHODS A thorough literature review was conducted in PubMed, PsychINFO, CINAHL, and Google Scholar for articles describing the safety and efficacy of ketamine use in treatment-resistant depression. Based on the current research, an educational video reporting the benefits and safety of ketamine was developed and launched on two social media platforms—YouTube and Facebook—for individuals to view. The effectiveness of the video was evaluated through the number of views, likes, shares, and comments recorded. RESULTS At 9 months, 156 views, 60 likes, 8 shares, and 4 comments were recorded in both platforms. Comments indicated that viewers found the video informative and encouraging. CONCLUSIONS A short evidence-based educational video provides individuals with information regarding the safety and efficacy of low-dose ketamine infusions as an option for depression treatment. Ketamine outpatient clinics support and treat depressed patients who do not benefit from conventional pharmacologic medications.

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.

Esketamine: A Novel Option for Treatment-Resistant Depression

2019 ◽  
Vol 54 (6) ◽  
pp. 567-576 ◽  
Author(s):  
Kevin M. Bozymski ◽  
Ericka L. Crouse ◽  
Erika N. Titus-Lay ◽  
Carol A. Ott ◽  
Jill L. Nofziger ◽  
...  
Keyword(s):  
English Language ◽  
Rating Scale ◽  
Data Extraction ◽  
Fixed Dose ◽  
Depression Symptoms ◽  
Treatment Resistant Depression ◽  
Treatment Resistant ◽  
Pubmed Search ◽  
Resistant Depression ◽  
Suicidal Thoughts And Behaviors

Objective:To review the pharmacology, pharmacokinetics, efficacy, safety, use requirements, and place in therapy of esketamine for treatment-resistant depression (TRD). Data Sources: A comprehensive PubMed search (1966 to October 2019) was conducted using the search terms depression, treatment-resistant, suicide, intranasal, esketamine, and JNJ-54135419. Additional data were obtained from references of identified articles, governmental sources, manufacturer product labeling, and Clinicaltrials.gov . Study Selection and Data Extraction: All English-language trials evaluating intranasal esketamine for TRD were included and discussed. Data Synthesis: Intranasal esketamine was approved by the US Food and Drug Administration, in conjunction with an oral antidepressant, for treating TRD in adults. Two short-term trials (TRANSFORM-1 and -2) found statistically significant reduction in the Montgomery-Asberg Depression Rating Scale score at day 28 for the fixed 56-mg dose (−4.1; 95% CI = −7.69 to −0.49; P = 0.027 [exploratory]) and flexible-dosed arms (−4.0; 95% CI = −7.31 to −0.64; P = 0.02), though the fixed-dose 84-mg arm (−3.2; 95% CI = −6.88 to 0.45; P = 0.088) of TRANSFORM-1 and TRANSFORM-3 did not (−3.6; 95% CI = −7.2 to 0.07; P = 0.059). Two long-term trials (SUSTAIN-1 and -2) suggested maintenance of response with continued use. Esketamine’s adverse effects include dizziness, dysgeusia, somnolence, dissociation, suicidal thoughts and behaviors, and increased heart rate and blood pressure. Relevance to Patient Care and Clinical Practice: Although providing a novel antidepressant mechanism and formulation for TRD, esketamine’s role in treatment will likely be limited by cost, administration, and diversion concerns. Conclusion: Intranasal esketamine significantly reduced depression symptoms in TRD, though with tolerability issues.

scholarly journals Novel drug developmental strategies for treatment‐resistant depression

2021 ◽  
Author(s):  
Éva Borbély ◽  
Mária Simon ◽  
Eberhard Fuchs ◽  
Ove Wiborg ◽  
Boldizsár Czéh ◽  
...  
Keyword(s):  
Treatment Resistant Depression ◽  
Treatment Resistant ◽  
Resistant Depression ◽  
Novel Drug

Effects of subcutaneous esketamine on blood pressure and heart rate in treatment-resistant depression

2020 ◽  
Vol 34 (10) ◽  
pp. 1155-1162
Author(s):  
Lorena Catarina Del Sant ◽  
Luciana Maria Sarin ◽  
Eduardo Jorge Muniz Magalhães ◽  
Ana Cecília Lucchese ◽  
Marco Aurélio Tuena ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Heart Rate ◽  
Vital Signs ◽  
Response To Treatment ◽  
Treatment Resistant Depression ◽  
Treatment Resistant ◽  
Post Dose ◽  
Before And After ◽  
Resistant Depression ◽  
The Impact

Introduction and objectives: The impact of multiple subcutaneous (s.c.) esketamine injections on the blood pressure (BP) and heart rate (HR) of patients with unipolar and bipolar treatment-resistant depression (TRD) is poorly understood. This study aimed to assess the cardiovascular safety of multiple s.c. doses of esketamine in patients with TRD. Methods: Seventy TRD patients received 394 weekly s.c. esketamine injections in conjunction with oral antidepressant therapy for up to six weeks. Weekly esketamine doses were 0.5, 0.75 or 1.0 mg/kg according to each patient’s response to treatment. Participants were monitored before each treatment and every 15 minutes thereafter for 120 minutes. We assessed systolic blood pressure (SBP), diastolic blood pressure (DBP), and HR measurements for the entire treatment course. Results: BP increased after the first s.c. esketamine injection, reaching maximum mean SBP/DBP levels of 4.87/5.54 mmHg within 30–45 minutes. At the end of monitoring, 120 minutes post dose, vital signs returned to pretreatment levels. We did not detect significant differences in BP between doses of 0.5, 0.75, and 1 mg/kg esketamine. Mean HR did not differ significantly between doses or before and after s.c. esketamine injection. Conclusions: The BP changes observed with repeated s.c. esketamine injections were mild and well tolerated for doses up to 1 mg/kg. The s.c. route is a simple and safe method of esketamine administration, even for patients with clinical comorbidities, including obesity, hypertension, diabetes, and dyslipidemia. However, 14/70 patients experienced treatment-emergent transient hypertension (SBP >180 mmHg and/or a DBP >110 mmHg). Therefore, we strongly recommend monitoring BP for 90 minutes after esketamine dosing. Since s.c. esketamine is cheap, requires less frequent dosing (once a week), and is a simpler procedure compared to intravenous infusions, it might have an impact on public health.

Therapeutic Strategies for Treatment-resistant Depression: State of the Art and Future Perspectives

2020 ◽  
Vol 26 (2) ◽  
pp. 244-252
Author(s):  
Kah K. Goh ◽  
Shen-Chieh Chang ◽  
Chun-Hsin Chen ◽  
Mong-Liang Lu
Keyword(s):  
Antidepressant Treatment ◽  
Repetitive Transcranial Magnetic Stimulation ◽  
Treatment Options ◽  
Therapeutic Strategies ◽  
Evidence Based ◽  
Inadequate Response ◽  
Treatment Resistant Depression ◽  
Treatment Resistant ◽  
Treatment Choices ◽  
Resistant Depression

In this narrative review, we intended to summarize the evidence of pharmacological and somatic treatment choices for treatment-resistant depression (TRD). There are several types of therapeutic strategies to improve inadequate response to antidepressant treatment. The first step for patients with TRD is to optimize the dosage and duration of antidepressants as well as to ensure their drug compliance. The shift to antidepressant and antidepressant combination therapy for patients with TRD cannot be regarded as an evidence-based strategy. Only the combination of a monoamine reuptake inhibitor with a presynaptic α2-autoreceptor antagonist might have better efficacy than other antidepressant combinations. Currently, the most evidence-based treatment options for TRD are augmentation strategies. Among augmentative agents, second-generation antipsychotics and lithium have the strongest evidence for the management of TRD. Further studies are needed to evaluate the augmentative efficacy of anticonvulsants, thyroid hormone, glutamatergic agents, anti-inflammatory agents, and nutraceuticals for TRD. Among somatic therapies, electroconvulsive therapy and repetitive transcranial magnetic stimulation are effective for TRD. Further studies are warranted to provide clinicians with a better recommendation in making treatment choices in patients with TRD.

scholarly journals Oral S-ketamine effective after deep brain stimulation in severe treatment-resistant depression and extensive comorbidities

2021 ◽  
Vol 14 (1) ◽  
pp. e238135
Author(s):  
Jolien K E Veraart ◽  
Jeanine Kamphuis ◽  
Mathis Schlegel ◽  
Robert A Schoevers
Keyword(s):  
Deep Brain Stimulation ◽  
Brain Stimulation ◽  
Maintenance Treatment ◽  
Severe Depression ◽  
Treatment Resistant Depression ◽  
Treatment Resistant ◽  
Obsessive Compulsive ◽  
Obsessive Compulsive Symptoms ◽  
Resistant Depression ◽  
Deep Brain

This case report describes successful maintenance treatment with oral S-ketamine in a patient with severe depression, who previously was resistant to electroconvulsive therapy and deep brain stimulation, and who also had comorbid psychotic and obsessive compulsive symptoms.

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