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  1. Article: Treatment response to esketamine nasal spray in patients with major depressive disorder and acute suicidal ideation or behavior without evidence of early response: a pooled post hoc analysis of ASPIRE.

    Turkoz, Ibrahim / Lopena, Oliver / Salvadore, Giacomo / Sanacora, Gerard / Shelton, Richard / Fu, Dong-Jing

    CNS spectrums

    2022  , Page(s) 1–7

    Abstract: Objective: To assess the likelihood of attaining response/remission of depressive symptoms with esketamine nasal spray (ESK) plus standard of care (SoC) vs placebo nasal spray (PBO) plus SoC at 4 weeks in patients with major depressive disorder and ... ...

    Abstract Objective: To assess the likelihood of attaining response/remission of depressive symptoms with esketamine nasal spray (ESK) plus standard of care (SoC) vs placebo nasal spray (PBO) plus SoC at 4 weeks in patients with major depressive disorder and active suicidal ideation with intent (MDSI) without early response.
    Methods: A post hoc analysis of pooled data from ASPIRE I and ASPIRE II evaluated ESK plus SoC vs PBO plus SoC in adults with MDSI without response (≥50% improvement from baseline in Montgomery-Åsberg Depression Rating Scale [MADRS] score) at 24 hours after the first dose or at week 1 after the first two doses (ie, 24-hour and week 1 nonresponders). Response and remission (MADRS score ≤ 12) rates were assessed on day 25.
    Results: The analysis included 362 patients (n = 182, ESK plus SoC; n = 180, PBO plus SoC). Among 24-hour nonresponders, more patients receiving ESK plus SoC vs PBO plus SoC achieved response (63.9% vs 48.0%,
    Conclusions: Patients with MDSI not responding within the first week of treatment with ESK plus SoC may still benefit from a full 4-week treatment course.
    Language English
    Publishing date 2022-07-29
    Publishing country United States
    Document type Journal Article
    ZDB-ID 2008418-3
    ISSN 2165-6509 ; 1092-8529
    ISSN (online) 2165-6509
    ISSN 1092-8529
    DOI 10.1017/S1092852922000931
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  2. Article ; Online: Predictors of response and remission in patients with treatment-resistant depression: A post hoc pooled analysis of two acute trials of esketamine nasal spray.

    Turkoz, Ibrahim / Nelson, J Craig / Wilkinson, Samuel T / Borentain, Stephane / Macaluso, Matthew / Trivedi, Madhukar H / Williamson, David / Sheehan, John J / Salvadore, Giacomo / Singh, Jaskaran / Daly, Ella

    Psychiatry research

    2023  Volume 323, Page(s) 115165

    Abstract: 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 oral AD plus ... ...

    Abstract 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 oral AD plus placebo nasal spray (AD+PBO; n = 208) in patients with treatment-resistant depression (TRD) examined baseline patient demographic and psychiatric characteristics as potential predictors of response (≥50% reduction from baseline in Montgomery-Åsberg Depression Rating Scale [MADRS] total score) and remission (MADRS total score ≤12) at day 28. Overall, younger age, any employment, fewer failed ADs in the current depressive episode, and reduction in Clinical Global Impression-Severity (CGI-S) score at day 8 were significant positive predictors of response and remission at day 28. Treatment assignment was an important predictor of both response and remission. Patients treated with ESK+AD had 68% and 55% increased odds of achieving response and remission, respectively, versus those treated with AD+PBO. In the ESK+AD group, attainment of response and remission was more likely in patients who were employed, without significant anxiety at baseline, and who experienced a reduction in CGI-S score at day 8. Identification of predictors of response and remission may facilitate identification of those patients with TRD most likely to benefit from ESK+AD. Trial Registration: ClinicalTrials.gov: NCT02417064 (clinicaltrials.gov/ct2/show/NCT02417064) and NCT02418585 (clinicaltrials.gov/ct2/show/NCT02418585).
    MeSH term(s) Humans ; Antidepressive Agents ; Depression ; Depressive Disorder, Major/psychology ; Depressive Disorder, Treatment-Resistant/drug therapy ; Double-Blind Method ; Nasal Sprays ; Treatment Outcome
    Chemical Substances Antidepressive Agents ; Esketamine (50LFG02TXD) ; Nasal Sprays
    Language English
    Publishing date 2023-03-16
    Publishing country Ireland
    Document type Clinical Trial, Phase III ; Journal Article ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
    ZDB-ID 445361-x
    ISSN 1872-7123 ; 1872-7506 ; 0925-4927 ; 0165-1781
    ISSN (online) 1872-7123 ; 1872-7506
    ISSN 0925-4927 ; 0165-1781
    DOI 10.1016/j.psychres.2023.115165
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  3. Article ; Online: Ketamine as a fast acting antidepressant: current knowledge and open questions.

    Salvadore, Giacomo / Singh, Jaskaran B

    CNS neuroscience & therapeutics

    2013  Volume 19, Issue 6, Page(s) 428–436

    Abstract: Several recent studies have shown that a single intravenous subanesthetic dose of ketamine, a NMDA receptor antagonist, exerts rapid antidepressant effects in patients with treatment refractory mood disorders and reduces suicidal ideation. Those insights ...

    Abstract Several recent studies have shown that a single intravenous subanesthetic dose of ketamine, a NMDA receptor antagonist, exerts rapid antidepressant effects in patients with treatment refractory mood disorders and reduces suicidal ideation. Those insights have fueled tremendous excitement in the efforts to elucidate the mechanism underlying ketamine's antidepressant properties in animal models of depression, as well as in humans through the use of brain imaging as well as peripheral blood measurements. For example, there is emerging evidence that ketamine's antidepressant properties rely on increasing AMPA signaling and rapidly inducing synaptogenesis. While pilot clinical studies are promising, a number of critical questions still remain unanswered. They relate to the safe and effective use of ketamine in patients with mood disorders regarding the optimal dose range, modality and method of administration for acute and long-term maintenance of effect, and the biomarkers associated with response/nonresponse. In this review article, we first summarize the clinical evidence about the use of ketamine in mood disorders, as well as preclinical and humans studies which investigated the mechanisms of action of ketamine, and predictors of antidepressant response in clinical populations. We then provide a critical overview of the knowledge gaps about the use of ketamine in depression and suggest some future research directions for the investigation of ketamine as a promising tool to develop novel more effective and fast acting antidepressants.
    MeSH term(s) Animals ; Antidepressive Agents/therapeutic use ; Clinical Trials as Topic ; Depression/drug therapy ; Drug Evaluation, Preclinical ; Glutamic Acid/metabolism ; Humans ; Ketamine/therapeutic use
    Chemical Substances Antidepressive Agents ; Glutamic Acid (3KX376GY7L) ; Ketamine (690G0D6V8H)
    Language English
    Publishing date 2013-04-12
    Publishing country England
    Document type Journal Article ; Review
    ZDB-ID 2423461-8
    ISSN 1755-5949 ; 1755-5930
    ISSN (online) 1755-5949
    ISSN 1755-5930
    DOI 10.1111/cns.12103
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  4. Article ; Online: Treatment Response With Esketamine Nasal Spray Plus an Oral Antidepressant in Patients With Treatment-Resistant Depression Without Evidence of Early Response: A Pooled Post Hoc Analysis of the TRANSFORM Studies.

    Turkoz, Ibrahim / Daly, Ella / Singh, Jaskaran / Lin, Xiwu / Tymofyeyev, Yevgen / Williamson, David / Salvadore, Giacomo / Nash, Abigail I / Macaluso, Matthew / Wilkinson, Samuel T / Nelson, J Craig

    The Journal of clinical psychiatry

    2021  Volume 82, Issue 4

    Abstract: Objective:: Methods:: Results:: Conclusions:: Trial Registration: ...

    Abstract Objective:
    Methods:
    Results:
    Conclusions:
    Trial Registration:
    MeSH term(s) Administration, Intranasal ; Administration, Oral ; Adult ; Antidepressive Agents/administration & dosage ; Depressive Disorder, Major/drug therapy ; Depressive Disorder, Treatment-Resistant/drug therapy ; Double-Blind Method ; Drug Administration Schedule ; Drug Therapy, Combination ; Female ; Humans ; Ketamine/administration & dosage ; Male ; Middle Aged ; Nasal Sprays
    Chemical Substances Antidepressive Agents ; Nasal Sprays ; Esketamine (50LFG02TXD) ; Ketamine (690G0D6V8H)
    Language English
    Publishing date 2021-07-20
    Publishing country United States
    Document type Clinical Trial, Phase III ; Journal Article ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
    ZDB-ID 716287-x
    ISSN 1555-2101 ; 0160-6689
    ISSN (online) 1555-2101
    ISSN 0160-6689
    DOI 10.4088/JCP.20m13800
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  5. Article ; Online: Magnetic resonance spectroscopy studies of the glutamatergic system in mood disorders: a pathway to diagnosis, novel therapeutics, and personalized medicine?

    Salvadore, Giacomo / Zarate, Carlos A

    Biological psychiatry

    2010  Volume 68, Issue 9, Page(s) 780–782

    MeSH term(s) Biomarkers/metabolism ; Drug Delivery Systems/methods ; Glutamic Acid/metabolism ; Humans ; Magnetic Resonance Spectroscopy/methods ; Models, Neurological ; Mood Disorders/diagnosis ; Mood Disorders/drug therapy ; Precision Medicine/methods
    Chemical Substances Biomarkers ; Glutamic Acid (3KX376GY7L)
    Language English
    Publishing date 2010-10-12
    Publishing country United States
    Document type Comment ; Journal Article ; Research Support, N.I.H., Intramural
    ZDB-ID 209434-4
    ISSN 1873-2402 ; 0006-3223
    ISSN (online) 1873-2402
    ISSN 0006-3223
    DOI 10.1016/j.biopsych.2010.09.011
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  6. Article ; Online: Motor cortical excitability and paired-associative stimulation-induced plasticity in amnestic mild cognitive impairment and Alzheimer's disease.

    Meder, Adam / Liepelt-Scarfone, Inga / Sulzer, Patricia / Berg, Daniela / Laske, Christoph / Preische, Oliver / Desideri, Debora / Zipser, Carl M / Salvadore, Giacomo / Tatikola, Kanaka / Timmers, Maarten / Ziemann, Ulf

    Clinical neurophysiology : official journal of the International Federation of Clinical Neurophysiology

    2021  Volume 132, Issue 9, Page(s) 2264–2273

    Abstract: Objective: Synaptopathy including alterations of synaptic plasticity (long-term potentiation, LTP) may precede neurodegeneration in Alzheimer's disease (AD). We studied LTP-like corticospinal plasticity induced by paired-associative stimulation (PAS: ... ...

    Abstract Objective: Synaptopathy including alterations of synaptic plasticity (long-term potentiation, LTP) may precede neurodegeneration in Alzheimer's disease (AD). We studied LTP-like corticospinal plasticity induced by paired-associative stimulation (PAS
    Methods: 15 AD and 15 aMCI patients, and 23 demographically matched healthy controls (HC) were included. Resting motor threshold (RMT) and stimulus intensity needed to evoke motor evoked potentials (MEP) of 1 mV (SI1mV) were obtained as single-pulse transcranial magnetic stimulation (TMS) measures of corticospinal excitability in a hand muscle at baseline, followed by PAS
    Results: SI1mV were lower in aMCI compared to HC, while there was no difference between AD and HC. RMT and SI1mV showed excellent test-retest reliability in all groups. PAS
    Conclusions: aMCI shows corticospinal hyperexcitability, consistent with glutamatergic excitotoxicity in early-stage AD. Possible abnormalities of LTP-like plasticity could not be reliably tested with the standard PAS
    Significance: Findings indicate corticospinal hyperexcitability in prodromal AD, and reliability of single-pulse TMS measures for identifying such abnormality. In contrast, the standard PAS
    MeSH term(s) Aged ; Aged, 80 and over ; Alzheimer Disease/physiopathology ; Cognitive Dysfunction/physiopathology ; Evoked Potentials, Motor ; Female ; Humans ; Long-Term Potentiation ; Male ; Middle Aged ; Motor Cortex/physiopathology ; Transcranial Magnetic Stimulation
    Language English
    Publishing date 2021-02-03
    Publishing country Netherlands
    Document type Journal Article
    ZDB-ID 1463630-x
    ISSN 1872-8952 ; 0921-884X ; 1388-2457
    ISSN (online) 1872-8952
    ISSN 0921-884X ; 1388-2457
    DOI 10.1016/j.clinph.2021.01.011
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  7. Article ; Online: The effect of esketamine in patients with treatment-resistant depression with and without comorbid anxiety symptoms or disorder.

    Daly, Ella J / Turkoz, Ibrahim / Salvadore, Giacomo / Fedgchin, Maggie / Ionescu, Dawn F / Starr, H Lynn / Borentain, Stephane / Trivedi, Madhukar H / Thase, Michael E / Singh, Jaskaran B

    Depression and anxiety

    2021  Volume 38, Issue 11, Page(s) 1120–1130

    Abstract: Background: Comorbid anxiety is generally associated with poorer response to antidepressant treatment. This post hoc analysis explored the efficacy of esketamine plus an antidepressant in patients with treatment-resistant depression (TRD) with or ... ...

    Abstract Background: Comorbid anxiety is generally associated with poorer response to antidepressant treatment. This post hoc analysis explored the efficacy of esketamine plus an antidepressant in patients with treatment-resistant depression (TRD) with or without comorbid anxiety.
    Methods: TRANSFORM-2, a double-blind, flexible-dose, 4-week study (NCT02418585), randomized adults with TRD to placebo or esketamine nasal spray, each with a newly-initiated oral antidepressant. Comorbid anxiety was defined as clinically noteworthy anxiety symptoms (7-item Generalized Anxiety Disorder scale [GAD-7] score ≥10) at screening and baseline or comorbid anxiety disorder diagnosis at screening. Treatment effect based on change in Montgomery-Åsberg Depression Rating Scale (MADRS) total score, and response and remission were examined by presence/absence of comorbid anxiety using analysis of covariance and logistic regression models.
    Results: Approximately 72% (162/223) of patients had baseline comorbid anxiety. Esketamine-treated patients with and without anxiety demonstrated significant reductions in MADRS (mean [SD] change from baseline at day 28: -21.0 [12.51] and -22.7 [11.98], respectively). Higher rates of response and remission, and a significantly greater decrease in MADRS score at day 28 were observed compared to antidepressant/placebo, regardless of comorbid anxiety (with anxiety: difference in LS means [95% CI] -4.2 [-8.1, -0.3]; without anxiety: -7.5 [-13.7, -1.3]). There was no significant interaction of treatment and comorbid anxiety (p = .371). Notably, in the antidepressant/placebo group improvement was similar in those with and without comorbid anxiety.
    Conclusion: Post hoc data support efficacy of esketamine plus an oral antidepressant in patients with TRD, regardless of comorbid anxiety.
    MeSH term(s) Adult ; Anxiety ; Depression ; Depressive Disorder, Treatment-Resistant/drug therapy ; Depressive Disorder, Treatment-Resistant/epidemiology ; Double-Blind Method ; Drug Therapy, Combination ; Humans ; Ketamine ; Treatment Outcome
    Chemical Substances Esketamine (50LFG02TXD) ; Ketamine (690G0D6V8H)
    Language English
    Publishing date 2021-07-22
    Publishing country United States
    Document type Journal Article ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
    ZDB-ID 1378635-0
    ISSN 1520-6394 ; 1091-4269
    ISSN (online) 1520-6394
    ISSN 1091-4269
    DOI 10.1002/da.23193
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  8. Article: Executive Function Is Related to the Urinary Urgency in Non-demented Patients With Parkinson's Disease.

    Tkaczynska, Zuzanna / Becker, Sara / Maetzler, Walter / Timmers, Maarten / Van Nueten, Luc / Sulzer, Patricia / Salvadore, Giacomo / Schäffer, Eva / Brockmann, Kathrin / Streffer, Johannes / Berg, Daniela / Liepelt-Scarfone, Inga

    Frontiers in aging neuroscience

    2020  Volume 12, Page(s) 55

    Abstract: ... ...

    Abstract Introduction
    Language English
    Publishing date 2020-03-06
    Publishing country Switzerland
    Document type Journal Article
    ZDB-ID 2558898-9
    ISSN 1663-4365
    ISSN 1663-4365
    DOI 10.3389/fnagi.2020.00055
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  9. Article ; Online: Association of cognitive activities of daily living (ADL) function and nonmotor burden in nondemented Parkinson's disease patients.

    Becker, Sara / Bäumer, Alena / Maetzler, Walter / Nussbaum, Susanne / Tkaczynska, Zuzanna / Sulzer, Patricia / Timmers, Maarten / Van Nueten, Luc / Salvadore, Giacomo / Brockmann, Kathrin / Streffer, Johannes / Berg, Daniela / Liepelt-Scarfone, Inga

    Neuropsychology

    2020  Volume 34, Issue 4, Page(s) 447–455

    Abstract: Objective: In Parkinson's disease (PD), nonmotor symptoms (NMS) considerably influence disease progression and cognitive decline. Depression, anxiety, sleep disturbances, and hallucinations (DASH), may indicate a risk for dementia (PDD). Mild ... ...

    Abstract Objective: In Parkinson's disease (PD), nonmotor symptoms (NMS) considerably influence disease progression and cognitive decline. Depression, anxiety, sleep disturbances, and hallucinations (DASH), may indicate a risk for dementia (PDD). Mild impairments in activities of daily living (ADL) caused by cognitive dysfunction are also present in the prodromal stage of PDD. The association of both factors has been sparsely investigated. Aim was to evaluate these specific NMS in a large nondemented PD cohort and their co-occurrence with cognitive dysfunction and ADL impairments.
    Method: Data of 226 PD patients was analyzed. Using corresponding items, two DASH scores were constructed from the NMS-Scale and Parkinson's disease Questionnaire (PDQ-39). Correlations between DASH scores and PDD risk factors were examined. PD patients with mild cognitive impairment (PD-MCI) were additionally split into patients with low and high DASH burden, the latter group additionally stratified by presence of cognitive-driven ADL impairment.
    Results: DASH-NMS scores differed significantly between PD-MCI and cognitively normal (PD-CN) patients (
    Conclusion: Our results show that the DASH-NMS is superior to the DASH-PDQ score, related to the severity of cognitive impairment, and strongly influenced by cognitive-driven ADL impairment. Presence of DASH symptoms and cognitive-ADL in PD-MCI patients may define a risk group for PDD conversion. (PsycInfo Database Record (c) 2020 APA, all rights reserved).
    MeSH term(s) Activities of Daily Living/psychology ; Age of Onset ; Aged ; Aged, 80 and over ; Cognition ; Cognitive Dysfunction/etiology ; Cognitive Dysfunction/psychology ; Cohort Studies ; Demography ; Disease Progression ; Female ; Humans ; Male ; Middle Aged ; Neuropsychological Tests ; Parkinson Disease/complications ; Parkinson Disease/psychology ; Surveys and Questionnaires
    Language English
    Publishing date 2020-03-19
    Publishing country United States
    Document type Journal Article
    ZDB-ID 1042412-x
    ISSN 1931-1559 ; 0894-4105
    ISSN (online) 1931-1559
    ISSN 0894-4105
    DOI 10.1037/neu0000627
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  10. Article ; Online: Association of Hippocampal Subfields, CSF Biomarkers, and Cognition in Patients With Parkinson Disease Without Dementia.

    Becker, Sara / Granert, Oliver / Timmers, Maarten / Pilotto, Andrea / Van Nueten, Luc / Roeben, Benjamin / Salvadore, Giacomo / Galpern, Wendy R / Streffer, Johannes / Scheffler, Klaus / Maetzler, Walter / Berg, Daniela / Liepelt-Scarfone, Inga

    Neurology

    2020  Volume 96, Issue 6, Page(s) e904–e915

    Abstract: Objective: To examine whether hippocampal volume loss is primarily associated with cognitive status or pathologic β-amyloid 1-42 (Aβ42) levels, this study compared hippocampal subfield volumes between patients with Parkinson disease (PD) with mild ... ...

    Abstract Objective: To examine whether hippocampal volume loss is primarily associated with cognitive status or pathologic β-amyloid 1-42 (Aβ42) levels, this study compared hippocampal subfield volumes between patients with Parkinson disease (PD) with mild cognitive impairment (PD-MCI) and without cognitive impairment (PD-CN) and between patients with low and high Aβ42 levels, in addition exploring the relationship among hippocampal subfield volumes, CSF biomarkers (Aβ42, phosphorylated and total tau), neuropsychological tests, and activities of daily living.
    Methods: Forty-five patients with PD without dementia underwent CSF analyses and MRI as well as comprehensive motor and neuropsychological examinations. Hippocampal segmentation was conducted using FreeSurfer image analysis suite 6.0. Regression models were used to compare hippocampal subfield volumes between groups, and partial correlations defined the association between variables while controlling for intracranial volume (ICV).
    Results: Linear regressions revealed cognitive group as a statistically significant predictor of both the hippocampal-amygdaloid transition area (HATA; β = -0.23, 95% CI -0.44 to -0.02) and the cornu ammonis 1 region (CA1; β = -0.28, 95% confidence interval [CI] -0.56 to -0.02), independent of disease duration and ICV, with patients with PD-MCI showing significantly smaller volumes than PD-CN. In contrast, no subfields were predicted by Aβ42 levels. Smaller hippocampal volumes were associated with worse performance on memory, language, spatial working memory, and executive functioning tests. The subiculum was negatively correlated with total tau levels (
    Conclusion: Cognitive status, but not CSF Aβ42, predicted hippocampal volumes, specifically the CA1 and HATA. Hippocampal subfields were associated with various cognitive domains, as well as with tau pathology.
    MeSH term(s) Activities of Daily Living ; Aged ; Amyloid beta-Peptides/cerebrospinal fluid ; Biomarkers/cerebrospinal fluid ; CA1 Region, Hippocampal/diagnostic imaging ; CA1 Region, Hippocampal/pathology ; Cognitive Dysfunction/etiology ; Cognitive Dysfunction/physiopathology ; Female ; Follow-Up Studies ; Hippocampus/diagnostic imaging ; Hippocampus/pathology ; Humans ; Magnetic Resonance Imaging ; Male ; Middle Aged ; Neuropsychological Tests ; Parkinson Disease/cerebrospinal fluid ; Parkinson Disease/complications ; Parkinson Disease/pathology ; Parkinson Disease/physiopathology ; Peptide Fragments/cerebrospinal fluid ; tau Proteins/cerebrospinal fluid
    Chemical Substances Amyloid beta-Peptides ; Biomarkers ; MAPT protein, human ; Peptide Fragments ; amyloid beta-protein (1-42) ; tau Proteins
    Language English
    Publishing date 2020-11-20
    Publishing country United States
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 207147-2
    ISSN 1526-632X ; 0028-3878
    ISSN (online) 1526-632X
    ISSN 0028-3878
    DOI 10.1212/WNL.0000000000011224
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