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.

scholarly journals Somatic Comorbidities and Cardiovascular Safety in Ketamine Use for Treatment-Resistant Depression

Medicina ◽  
2021 ◽  
Vol 57 (3) ◽  
pp. 274
Author(s):  
Joanna Szarmach ◽  
Wiesław Jerzy Cubała ◽  
Adam Włodarczyk ◽  
Maria Gałuszko-Węgielnik
Keyword(s):  
Diabetes Mellitus ◽  
Blood Pressure ◽  
Heart Rate ◽  
Small Sample ◽  
Tolerability Profile ◽  
Acute Administration ◽  
Treatment Resistant Depression ◽  
Treatment Resistant ◽  
Somatic Comorbidities ◽  
Resistant Depression

Background and Objectives: There is evidence for ketamine efficacy in treatment-resistant depression (TRD). Several safety and tolerability concerns arise that some psychotropic agents may provide blood pressure or/and heart rate alterations. The aim of this study is to review blood pressure measurements in course of the treatment with ketamine on treatment refractory inpatients with somatic comorbidities in the course of MDD and BP. Materials and Methods: The study population of 49 patients comprised MDD and BP subjects treated with ketamine registered in the naturalistic observational protocol of treatment-resistant mood disorders (NCT04226963). Results: The conducted analysis showed that among people suffering from hypertension there is a higher increase in systolic blood pressure (RR) after infusion 2 (p = 0.004) than among people who do not suffer from hypertension. Patients with hypertension have a higher increase in diastolic RR compared to those not suffering from hypertension (p = 0,038). Among the subjects with diabetes mellitus, significant differences occurred for infusions 2 (p = 0.020), 7 (p = 0.020), and 8 (p = 0.035) for heart rate (HR), compared to subjects without diabetes mellitus. A higher increase in diastolic RR was noted in the group of subjects suffering from diabetes mellitus (p = 0.010) compared to those who did not. In the hyperlipidemic patients studied, a significantly greater decrease in HR after infusion 5 (p = 0.031) and systolic RR after infusion 4 (p = 0.036) was noted compared to nonpatients. People after a stroke had significantly higher increases in diastolic RR after infusions 4 (p = 0.021) and 6 (p = 0.001) than those who did not have a stroke. Patients suffering from epilepsy had a significantly greater decrease in systolic RR after the 8th infusion (p = 0.017) compared to those without epilepsy. Limitations: The study may be underpowered due to the small sample size. The observations apply to inhomogeneous TRD population in a single-site with no blinding and are limited to the acute administration. Conclusions: This study supports evidence for good safety and tolerability profile for short-term IV ketamine use in TRD treatment. However, risk mitigation measures are to be considered in patients with metabolic and cardiovascular comorbidities.

scholarly journals Role of the Pharmacist in Managing Treatment-Resistant Depression: A Focus on Ketamine

Pharmacy ◽  
2021 ◽  
Vol 9 (3) ◽  
pp. 118
Author(s):  
Linda Xing Yu Liu ◽  
Marina Golts ◽  
Virginia Fernandes
Keyword(s):  
Current Practice ◽  
Quality Care ◽  
Treatment Options ◽  
Critical Role ◽  
Transitions Of Care ◽  
Treatment Resistant Depression ◽  
Treatment Resistant ◽  
Resistant Depression ◽  
Multiple Treatments ◽  
The Impact

The impact of depression is well described in the literature, and it is most prominent in patients who have trialed multiple treatments. Treatment-resistant depression (TRD) is particularly debilitating, and it is associated with significant morbidity and mortality. Despite this, there seems to be therapeutic inertia in adopting novel therapies in current practice. Ketamine is an N-methyl-D-aspartate receptor antagonist and anesthetic agent which has recently been shown to be effective in the management of TRD when administered intravenously or intranasally. The treatments, however, are not easily accessible due to restrictions in prescribing and dispensing, high costs, and the slow uptake of evidence-based practice involving ketamine within the Canadian healthcare system. Given the limited treatment options for TRD, novel approaches should be considered and adopted into practice, and facilitated by a multi-disciplinary approach. Pharmacists play a critical role in ensuring access to quality care. This includes dissemination of evidence supporting pharmacological treatments and facilitating translation into current practice. Pharmacists are uniquely positioned to collaborate with prescribers and assess novel treatment options, such as ketamine, address modifiable barriers to treatment, and triage access to medications during transitions of care. Extending the reach of these novel psychiatric treatments in both tertiary and primary care settings creates an emerging role for pharmacists in the collaborative effort to better manage treatment-resistant depression.

scholarly journals Comparative Study of Heart Rate, Blood Pressure and Selective Attention of Subjects Before and After Music

2019 ◽  
Vol 4 (1) ◽  
pp. 625-628
Author(s):  
Nisha Ghimire ◽  
Renu Yadav ◽  
Soumitra Mukhopadhyay
Keyword(s):  
Blood Pressure ◽  
Heart Rate ◽  
Reaction Time ◽  
Comparative Study ◽  
Error Correction ◽  
Vital Signs ◽  
Stroop Test ◽  
Before And After ◽  
Paired T Test ◽  
After Error

Introduction: Studies have shown different views regarding the effect of music in vitals e.g Heart rate (HR), Blood pressure (BP) and atiention. The effect of preferred music with lyrics in vitals and reaction time in stroop test has not been performed in Nepalese students so, we conducted the study. Objective: To find out the change in HR, BP and reaction time in Stroop test before and after their preferred music with lyrics. Methodology Thirty male medical and paramedical students aged 25.27 ± 2.0 participated in study. The vital signs and reaction time in Stroop test before and after music was taken. Results Paired-t test was used to compare means before and after exposure to music. The means are expressed as Mean ± SD. Heart rate (HR) increased after exposure to music (66.33±9.51 Vs 67.2±8.44) (p<.05). The error in Stroop test was less after music (.66±.49 Vs.63±.66) (p<.05). The reaction time after error correction decreased post exposure to music (24.117±4.61Vs23.29±4.45) (p<.05). Conclusion The heart rate increased after exposure to music. The errors decreased after listening to music which also decreased reaction time.

scholarly journals Safety and efficacy of extended release ketamine tablets in patients with treatment-resistant depression and anxiety: open label pilot study

2020 ◽  
Vol 10 ◽  
pp. 204512532092247 ◽  
Author(s):  
Paul Glue ◽  
Natalie J. Medlicott ◽  
Shona Neehoff ◽  
Peter Surman ◽  
Fred Lam ◽  
...  
Keyword(s):  
Extended Release ◽  
Vital Signs ◽  
Oral Formulation ◽  
Depression And Anxiety ◽  
Treatment Resistant Depression ◽  
Treatment Resistant ◽  
Open Label ◽  
Oral Ketamine ◽  
Tolerability Data ◽  
Resistant Depression

Background: Ketamine’s defining side effects are dissociation and increased blood pressure/heart rate. An oral formulation with delayed absorption could minimize these effects. We recently reported safety and tolerability data for an extended release ketamine tablet in healthy volunteers. Methods: To assess safety, tolerability, efficacy, and pharmacokinetics of an extended release oral ketamine tablet in patients with treatment-resistant depression/anxiety. This was a multiple dose open-label flexible dose uncontrolled study in seven patients with treatment-resistant depression/anxiety, who had all previously demonstrated mood improvement to subcutaneous ketamine. Assessments included ratings of anxiety, depression and dissociation, safety and tolerability, and blood samples for ketamine pharmacokinetics and brain-derived neurotrophic factor (BDNF) concentrations. Results: Improvements in anxiety and depression ratings occurred gradually over 96 h; all patients had >50% improvements in mood ratings. Ketamine was safe and well tolerated, with no changes in vital signs, and a single brief report of dissociation. Ketamine may induce its own metabolism, as the ratio of norketamine to ketamine increased out to 96 h. Serum BDNF concentrations did not change during the study. Conclusion: Ketamine’s safety/tolerability may be improved with an extended release oral formulation. Onset of mood improvement is slightly delayed compared with parenteral dosing. These data support the further development of extended release ketamine tablets for treatment of resistant depression and anxiety disorders.

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.

scholarly journals Managing Esketamine Treatment Frequency Toward Successful Outcomes: Analysis of Phase 3 Data

2020 ◽  
Vol 23 (7) ◽  
pp. 426-433 ◽  
Author(s):  
Michel Nijs ◽  
Ewa Wajs ◽  
Leah Aluisio ◽  
Ibrahim Turkoz ◽  
Ella Daly ◽  
...  
Keyword(s):  
Nasal Spray ◽  
Rating Scale ◽  
Maintenance Phase ◽  
Induction Phase ◽  
Treatment Resistant Depression ◽  
Treatment Resistant ◽  
Open Label ◽  
Treatment Frequency ◽  
Resistant Depression ◽  
The Impact

Abstract Background Esketamine nasal spray was recently approved for treatment-resistant depression. The current analysis evaluated the impact of symptom-based treatment frequency changes during esketamine treatment on clinical outcomes. Methods This is a post-hoc analysis of an open-label, long-term (up to 1 year) study of esketamine in patients with treatment-resistant depression (SUSTAIN 2). During a 4-week induction phase, 778 patients self-administered esketamine twice weekly plus a new oral antidepressant daily. In responders (≥50% reduction in Montgomery-Åsberg Depression Rating Scale total score from baseline), esketamine treatment frequency was thereafter decreased during an optimization/maintenance phase to weekly for 4 weeks and then adjusted to the lowest frequency (weekly or every other week) that maintained remission (Montgomery-Åsberg Depression Rating Scale ≤ 12) based on a study-defined algorithm. The relationship between treatment frequency and symptom response, based on clinically meaningful change in Clinical Global Impression–Severity score, was subsequently evaluated 4 weeks after treatment frequency adjustments in the optimization/maintenance phase. Results Among 580 responders treated with weekly esketamine for the first 4 weeks in the optimization/maintenance phase (per protocol), 26% continued to improve, 50% maintained clinical benefit, and 24% worsened. Thereafter, when treatment frequency could be reduced from weekly to every other week, 19% further improved, 49% maintained benefit, and 32% worsened. For patients no longer in remission after treatment frequency reduction, an increase (every other week to weekly) resulted in 47% improved, 43% remained unchanged, and 10% worsened. Conclusions These findings support individualization of esketamine nasal spray treatment frequency to optimize treatment response in real-world clinical practice. Trial Registration ClinicalTrials.gov identifier: NCT02497287

The impact of childhood adversity on suicidality and clinical course in treatment-resistant depression

2014 ◽  
Vol 152-154 ◽  
pp. 122-130 ◽  
Author(s):  
Catherine Tunnard ◽  
Lena J. Rane ◽  
Sarah C. Wooderson ◽  
Kalypso Markopoulou ◽  
Lucia Poon ◽  
...  
Keyword(s):  
Clinical Course ◽  
Childhood Adversity ◽  
Treatment Resistant Depression ◽  
Treatment Resistant ◽  
Resistant Depression ◽  
The Impact

scholarly journals Cardiovascular, lactate and appetite response to light and spicy music tempo after an endurance swimming protocol in young girls

2020 ◽  
Vol 24 (4) ◽  
pp. 195-202
Author(s):  
Javad Mehrabani ◽  
Soodabeh Bagherzadeh ◽  
Abuzar Jorbonian ◽  
Eisa Khaleghi-Mamaghani ◽  
Maryam Taghdiri ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Heart Rate ◽  
Recovery Period ◽  
Young Girls ◽  
Significant Difference ◽  
Before And After ◽  
Lactate Levels ◽  
The Impact

Background and Study Aim. During exercise, the effects of music on the performance have been previously evaluated. However, the superiority of the type of music and during recovery is not yet clear. Therefore the aim of this study was to determine the impact of music with a spicy and light beat on changes in lactate levels, blood pressure, heart rate, and appetite during the recovery period after the endurance swimming. Material and Methods. Thirteen healthy young girls participate in three control and experimental sessions. The participants performed a swimming. Immediately after swimming, they listened to music. Also, evaluations before and after (several times) swimming were performed.Results. Five minutes after swimming there was also a significant difference between the non-sound group with the music groups (p<0.05). Two and 5 minutes after swimming, there was a significant difference between the spicy and light music groups compared to the non-sound group. There was a significant difference between spicy and light music groups at time 10, 15 and 25 minutes. In the 25 minutes after the swim, reducing the heart rate in light music was more than spicy. Also, 10 minutes after swimming, the spicy music group could not cope with the increase in heart rate (p<0.05). There was a significant difference between the two music groups in minutes 5, 10 and 15 after swimming (p<0.05).Conclusions. listening to light music during recovery from endurance swimming was associated with decreased lactate levels and heart rate, but listening to spicy music increased heart rate and desire for food.

scholarly journals A Clinical Rationale for Assessing the Impact of Childhood Sexual Abuse on Adjunctive Subcutaneous Esketamine for Treatment-Resistant Depression

2021 ◽  
Vol 12 ◽  
Author(s):  
Eduardo Jorge Muniz Magalhães ◽  
Luciana Maria Sarin ◽  
Lorena Catarina Del Sant ◽  
Ana Cecília Lucchese ◽  
Carolina Nakahira ◽  
...  
Keyword(s):  
Sexual Abuse ◽  
Adult Population ◽  
Positive Family History ◽  
Poor Response ◽  
Depression Symptom ◽  
Treatment Resistant Depression ◽  
Treatment Resistant ◽  
History Of ◽  
Resistant Depression ◽  
The Impact

Background: A history of child sexual abuse (CSA) is related to higher suicide rates and poor treatment outcomes in depressed adult patients. Twenty years after the first study investigating the effects of ketamine/esketamine on depression and suicide, there is a lack of data on the CSA effects on this emerging treatment. Here, we assess the impact of CSA on adjunctive subcutaneous (SC) esketamine for treatment-resistant depression (TRD).Methods: A directed acyclic graphic (DAG) was designed to identify clinical confounders between CSA and esketamine predictors of response. The confounders were applied in a statistical model to predict depression symptom trajectory in a sample of 67 TRD outpatients.Results: The patient sample had a relatively high prevalence rate of CSA (35.82%). Positive family history of first-degree relatives with alcohol use disorder and sex were clinical mediators of the effects of esketamine in a CSA adult population. Overall, the presence of at least one CSA event was unrelated to esketamine symptom reduction.Conclusions: Unlike responses to conventional antidepressants and psychotherapy, CSA does not appear to predict poor response to esketamine.

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