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View article: Effect of Esketamine Nasal Spray on Cognition in Patients With Treatment-Resistant Depression: Results From Four Phase 3 Studies
Effect of Esketamine Nasal Spray on Cognition in Patients With Treatment-Resistant Depression: Results From Four Phase 3 Studies Open
Background While esketamine is effective in treatment-resistant depression (TRD), detailed information about the effect of esketamine on cognition is relatively scarce. This analysis assessed the effect of short-term (3 double-blind [DB] s…
View article: Suicide‐specific mortality among patients with treatment‐resistant major depressive disorder, major depressive disorder with prior suicidal ideation or suicide attempts, or major depressive disorder alone
Suicide‐specific mortality among patients with treatment‐resistant major depressive disorder, major depressive disorder with prior suicidal ideation or suicide attempts, or major depressive disorder alone Open
Background The impact of treatment‐resistant depression (TRD) or prior suicidal ideation/suicide attempt (SI/SA) on mortality by suicide among patients with major depressive disorder (MDD) is not well known. This retrospective, observation…
View article: Assessment of health-related quality of life and health status in patients with treatment-resistant depression treated with esketamine nasal spray plus an oral antidepressant
Assessment of health-related quality of life and health status in patients with treatment-resistant depression treated with esketamine nasal spray plus an oral antidepressant Open
Background Patients with treatment-resistant depression (TRD) report significant deficits in physical and mental health, as well as severely impaired health-related quality of life (HRQoL) and functioning. Esketamine effectively enhances t…
View article: Predictors of response and remission in patients with treatment-resistant depression: A post hoc pooled analysis of two acute trials of esketamine nasal spray
Predictors of response and remission in patients with treatment-resistant depression: A post hoc pooled analysis of two acute trials of esketamine nasal spray Open
This exploratory post hoc analysis of two pooled 4-week, phase 3, double-blind, placebo- and active-controlled studies that compared esketamine nasal spray plus a newly initiated oral antidepressant (ESK+AD; n = 310) with a newly initiated…
View article: Intranasal esketamine effectively treats treatment-resistant depression in adults regardless of baseline irritability
Intranasal esketamine effectively treats treatment-resistant depression in adults regardless of baseline irritability Open
ClinicalTrials.gov identifiers: NCT02417064 (TRANSFORM-1), NCT02418585 (TRANSFORM-2).
View article: Longitudinal Course of Adverse Events With Esketamine Nasal Spray
Longitudinal Course of Adverse Events With Esketamine Nasal Spray Open
Trial Registration: ClinicalTrials.gov identifiers: NCT02493868; NCT02497287.
View article: Montgomery‐Åsberg Depression Rating Scale factors in treatment‐resistant depression at onset of treatment: Derivation, replication, and change over time during treatment with esketamine
Montgomery‐Åsberg Depression Rating Scale factors in treatment‐resistant depression at onset of treatment: Derivation, replication, and change over time during treatment with esketamine Open
Objective Derive and confirm factor structure of the Montgomery‐Åsberg Depression Rating Scale (MADRS) in patients with treatment‐resistant depression (TRD) and evaluate how the factors evident at baseline change over 4 weeks of esketamine…
View article: Clinical consensus regarding the importance of rapid reduction in depressive symptoms in major depressive disorder with acute suicidal ideation or behavior (MDSI)
Clinical consensus regarding the importance of rapid reduction in depressive symptoms in major depressive disorder with acute suicidal ideation or behavior (MDSI) Open
Introduction Patients with major depressive disorder (MDD) with acute suicidal ideation or behavior (MDSI) require immediate intervention. Though oral antidepressants can be effective at reducing depressive symptoms, they can take 4–6 week…
View article: Efficacy and safety of esketamine nasal spray by sex in patients with treatment-resistant depression: findings from short-term randomized, controlled trials
Efficacy and safety of esketamine nasal spray by sex in patients with treatment-resistant depression: findings from short-term randomized, controlled trials Open
The objective of this analysis was to determine if there are sex differences with esketamine for treatment-resistant depression (TRD). Post hoc analyses of three randomized, controlled studies of esketamine in patients with TRD (TRANSFORM-…
View article: A Choice-Based Conjoint Analysis of the Psychiatrist Decision-Making Process Used in Determining When to Discharge Adults With Major Depressive Disorder Hospitalized for Active Suicidal Ideation With Intent
A Choice-Based Conjoint Analysis of the Psychiatrist Decision-Making Process Used in Determining When to Discharge Adults With Major Depressive Disorder Hospitalized for Active Suicidal Ideation With Intent Open
To ascertain the relative importance of attributes considered when deciding to discharge patients hospitalized with major depressive disorder (MDD) and active suicidal ideation with intent, a choice-based conjoint analysis was conducted vi…
View article: Mental Health Care Resource Utilization and Barriers to Receiving Mental Health Services Among US Adults With a Major Depressive Episode and Suicidal Ideation or Behavior With Intent
Mental Health Care Resource Utilization and Barriers to Receiving Mental Health Services Among US Adults With a Major Depressive Episode and Suicidal Ideation or Behavior With Intent Open
Conclusions: Although respondents in the MDSI cohort reported substantially higher MHRU across all categories, they also reported greater barriers to receiving care than those in the MDE cohort. This study documents the extensive burden an…
View article: The effect of esketamine in patients with treatment‐resistant depression with and without comorbid anxiety symptoms or disorder
The effect of esketamine in patients with treatment‐resistant depression with and without comorbid anxiety symptoms or disorder Open
Post hoc data support efficacy of esketamine plus an oral antidepressant in patients with TRD, regardless of comorbid anxiety.
View article: Treatment Response With Esketamine Nasal Spray Plus an Oral Antidepressant in Patients With Treatment-Resistant Depression Without Evidence of Early Response
Treatment Response With Esketamine Nasal Spray Plus an Oral Antidepressant in Patients With Treatment-Resistant Depression Without Evidence of Early Response Open
Trial Registration: ClinicalTrials.gov identifiers NCT02417064 and NCT02418585.
View article: Effect of Esketamine Nasal Spray on Olfactory Function and Nasal Tolerability in Patients with Treatment-Resistant Depression: Results from Four Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase III Studies
Effect of Esketamine Nasal Spray on Olfactory Function and Nasal Tolerability in Patients with Treatment-Resistant Depression: Results from Four Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase III Studies Open
TRANSFORM-1: NCT02417064, date of registration: 15/04/2015; TRANSFORM-2: NCT02418585, date of registration: 16/04/2015; TRANSFORM-3: NCT02422186, date of registration: 21/04/2015; SUSTAIN-1: NCT02493868, date of registration: 10/07/2015.
View article: Association of depression symptom severity with short-term risk of an initial hospital encounter in adults with major depressive disorder
Association of depression symptom severity with short-term risk of an initial hospital encounter in adults with major depressive disorder Open
Background Despite the availability of pharmacologic and nonpharmacologic treatment options, depression continues to be one of the leading causes of disability worldwide. This study evaluated whether depression symptom severity, as measure…
View article: Comments to Drs. Bahji, Vazquez, and Zarate
Comments to Drs. Bahji, Vazquez, and Zarate Open
In the absence of head-to-head studies directly comparing the efficacy of intranasal esketamine to that of intravenous ketamine, valid conclusions regarding comparative efficacy cannot be made based on the existing data from trials using m…
View article: How well do clinical and demographic characteristics predict Patient Health Questionnaire‐9 scores among patients with treatment‐resistant major depressive disorder in a real‐world setting?
How well do clinical and demographic characteristics predict Patient Health Questionnaire‐9 scores among patients with treatment‐resistant major depressive disorder in a real‐world setting? Open
Objectives To create and validate a model to predict depression symptom severity among patients with treatment‐resistant depression (TRD) using commonly recorded variables within medical claims databases. Methods Adults with TRD (here defi…
View article: Association of depression symptom severity with short-term risk of an initial hospital encounter in adults with major depressive disorder
Association of depression symptom severity with short-term risk of an initial hospital encounter in adults with major depressive disorder Open
Background: Despite the availability of pharmacologic and nonpharmacologic treatment options, depression continues to be one of the leading causes of disability worldwide. This study evaluated whether depression symptom severity, as measur…
View article: Clinically meaningful changes on depressive symptom measures and patient‐reported outcomes in patients with treatment‐resistant depression
Clinically meaningful changes on depressive symptom measures and patient‐reported outcomes in patients with treatment‐resistant depression Open
Objective To use the Clinical Global Impression‐Severity (CGI‐S) scale to estimate clinically meaningful and clinically substantial changes as measured using the Montgomery‐Åsberg Depression Rating Scale (MADRS), the Sheehan Disability Sca…
View article: Association of depression symptom severity with short-term risk of an initial hospital encounter in adults with major depressive disorder
Association of depression symptom severity with short-term risk of an initial hospital encounter in adults with major depressive disorder Open
BackgroundDespite the availability of pharmacologic and nonpharmacologic treatment options, depression continues to be one of the leading causes of disability worldwide. The impact of depression symptom severity on short-term risk of hospi…
View article: Self-reported review of the value of esketamine in patients with treatment-resistant depression: Understanding the patient experience in the STRIVE Study
Self-reported review of the value of esketamine in patients with treatment-resistant depression: Understanding the patient experience in the STRIVE Study Open
Esketamine nasal spray (ESK) is indicated, in conjunction with an oral antidepressant (OAD), for the management of treatment-resistant depression (TRD) in adults. Select US-based patients from an open-label, long-term extension safety stud…
View article: Economic Burden of Treatment-Resistant Depression in Privately Insured U.S. Patients with Physical Conditions
Economic Burden of Treatment-Resistant Depression in Privately Insured U.S. Patients with Physical Conditions Open
This study was sponsored by Janssen Scientific Affairs (JSA), which was involved in all aspects of the research, including the design of the study; the collection, analysis, and interpretation of data; writing of the report; and the decisi…
View article: Esketamine Nasal Spray Plus Oral Antidepressant in Patients With Treatment-Resistant Depression
Esketamine Nasal Spray Plus Oral Antidepressant in Patients With Treatment-Resistant Depression Open
ClinicalTrials.gov identifier: NCT02497287.
View article: Managing Esketamine Treatment Frequency Toward Successful Outcomes: Analysis of Phase 3 Data
Managing Esketamine Treatment Frequency Toward Successful Outcomes: Analysis of Phase 3 Data Open
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 Th…
View article: 119 Assessment of Health-Related Quality of Life and Health Status in Patients with Treatment-resistant Depression
119 Assessment of Health-Related Quality of Life and Health Status in Patients with Treatment-resistant Depression Open
Objective: To assess health-related quality of life (HRQoL) and health status of patients with treatment resistant depression (TRD), treated with esketamine nasal spray+oral antidepressant (ESK+AD) vs oral antidepressant+placebo nasal spra…