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3. Comparison of Long-Term Efficacy and Safety of Esketamine Nasal Spray Plus Oral Antidepressant in Younger Versus Older Patients With Treatment-Resistant Depression: Post-Hoc Analysis of SUSTAIN-2, a Long-Term Open-Label Phase 3 Safety and Efficacy Study

Author

Ochs-Ross, Rachel, Wajs, Ewa, Daly, Ella J., Zhang, Yun, Lane, Rosanne, Lim, Pilar, Drevets, Wayne C., Steffens, David C., Sanacora, Gerard, Jamieson, Carol, Hough, David, Manji, Husseini, and Singh, Jaskaran B.

Published
2022
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4. Effects of the selective AMPA modulator NBI‐1065845 on the pharmacokinetics of midazolam or ethinyl estradiol–levonorgestrel in healthy adults.

Author

Lin, Swan, Ionescu, Adrian, Maynard‐Scott, Jessica, Kennedy, Mike, Walling, David P., Furey, Maura, and Singh, Jaskaran B.

Subjects
ETHINYL estradiol, MIDAZOLAM, CYTOCHROME P-450, PHARMACOKINETICS, ADULTS, ORAL contraceptives, LEVONORGESTREL
Abstract

This parallel‐arm, phase I study investigated the potential cytochrome P450 (CYP)3A induction effect of NBI‐1065845 (TAK‐653), an investigational α‐amino‐3‐hydroxy‐5‐methyl‐4‐isoxazolepropionic acid receptor potentiator in phase II development for major depressive disorder. The midazolam treatment arm received the sensitive CYP3A substrate midazolam on Day 1, followed by NBI‐1065845 alone on Days 5–13; on Day 14, NBI‐1065845 was administered with midazolam, then NBI‐1065845 alone on Day 15. The oral contraceptive treatment arm received ethinyl estradiol–levonorgestrel on Day 1, then NBI‐1065845 alone on Days 5–13; on Day 14, NBI‐1065845 was administered with ethinyl estradiol–levonorgestrel, then NBI‐1065845 alone on Days 15–17. Blood samples were collected for pharmacokinetic analyses. The midazolam treatment arm comprised 14 men and 4 women, of whom 16 completed the study. Sixteen of the 17 healthy women completed the oral contraceptive treatment arm. After multiple daily doses of NBI‐1065845, the geometric mean ratios (GMRs) (90% confidence interval) for maximum observed concentration were: midazolam, 0.94 (0.79–1.13); ethinyl estradiol, 1.00 (0.87–1.15); and levonorgestrel, 0.99 (0.87–1.13). For area under the plasma concentration–time curve (AUC) from time 0 to infinity, the GMRs were as follows: midazolam, 0.88 (0.78–0.98); and ethinyl estradiol, 1.01 (0.88–1.15). For levonorgestrel, the GMR for AUC from time 0 to the last quantifiable concentration was 0.87 (0.78–0.96). These findings indicate that NBI‐1065845 is not a CYP3A inducer and support its administration with CYP3A substrates. NBI‐1065845 was generally well tolerated, with no new safety signals observed after coadministration of midazolam, ethinyl estradiol, or levonorgestrel. [ABSTRACT FROM AUTHOR]

Published
2024
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11. Adverse Events and Measurement of Dissociation After the First Dose of Esketamine in Patients With TRD.

Author

Williamson, David, Turkoz, Ibrahim, Wajs, Ewa, Singh, Jaskaran B, Borentain, Stephane, and Drevets, Wayne C

Subjects
TRANSCRANIAL magnetic stimulation, CLINICAL trials, ANTIDEPRESSANTS, LOGISTIC regression analysis, REGRESSION analysis, DULOXETINE, MENTAL depression, PSYCHOSES
Abstract

Background "Dissociation" comprises distinct phenomena, some of which are associated with esketamine treatment and some may overlap with positive symptoms of psychosis. Relationships between dissociation and psychotic symptoms assessed by -clinician report vs conventional rating scales were investigated in a post hoc analysis of data from the initial treatment session in an -open-label, -long-term safety, phase 3 study of esketamine plus a newly initiated oral antidepressant in patients with treatment-resistant depression. Methods Adverse events of dissociation or psychosis were examined via investigator report and the Clinician Administered Dissociative States Scale (CADSS) and Brief Psychiatric Rating Scale-Plus, respectively, 40 minutes post first esketamine dose. The range of CADSS total scores associated with investigator-reported severity of dissociation was determined by equipercentile linking. Logistic regression models and receiver operating curve analysis explored the CADSS cutoff point for determining presence/absence of dissociation. Frequency of response to specific CADSS items was examined to investigate qualitative differences in the pattern of symptoms reported across investigator-reported levels of adverse event severity. Results Dissociation was reported as an adverse event in 14.3% (109/764) of patients. Severity of most CADSS items increased with the severity of investigator-reported dissociation. No CADSS cutoff point discriminated well between the presence and absence of dissociation events. Hallucinations were reported as adverse events in 5 patients; none reported delusions. Conclusions CADSS scores and severity of dissociation adverse events move generally in the same direction; however, there is substantial variability in this relationship. No signature profile of dissociative experiences was revealed, and psychotic symptoms were uncommon. Trial Registration Clinical Trials.gov identifier: NCT02497287 [ABSTRACT FROM AUTHOR]

Published
2023
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12. Relationship Between Dissociation and Antidepressant Effects of Esketamine Nasal Spray in Patients With Treatment-Resistant Depression

Author

Chen, Guang, primary, Chen, Li, additional, Zhang, Yun, additional, Li, Xiang, additional, Lane, Rosanne, additional, Lim, Pilar, additional, Daly, Ella J, additional, Furey, Maura L, additional, Fedgchin, Maggie, additional, Popova, Vanina, additional, Singh, Jaskaran B, additional, and Drevets, Wayne C, additional

Published
2022
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15. Post hoc analyses of an open-label long-term study of esketamine nasal spray plus an oral antidepressant comparing results in older versus younger adults with treatment-resistant depression

Author

Ochs-Ross, Rachel, primary, Wajs, Ewa, additional, Daly, Ella J., additional, Zhang, Yun, additional, Lane, Rosanne, additional, Lim, Pilar, additional, Hough, David, additional, Manji, Husseini, additional, Drevets, Wayne C., additional, Steffens, David C., additional, and Singh, Jaskaran B., additional

Published
2021
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20. Esketamine Nasal Spray Plus Oral Antidepressant in Patients With Treatment-Resistant Depression

Author

Wajs, Ewa, primary, Aluisio, Leah, additional, Holder, Richard, additional, Daly, Ella J., additional, Lane, Rosanne, additional, Lim, Pilar, additional, George, Joyce E., additional, Morrison, Randall L., additional, Sanacora, Gerard, additional, Young, Allan H., additional, Kasper, Siegfried, additional, Sulaiman, Ahmad Hatim, additional, Li, Cheng-Ta, additional, Paik, Jong-Woo, additional, Manji, Husseini, additional, Hough, David, additional, Grunfeld, Jennifer, additional, Jeon, Hong Jin, additional, Wilkinson, Samuel T., additional, Drevets, Wayne C., additional, and Singh, Jaskaran B., additional

Published
2020
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27. Efficacy of Esketamine Nasal Spray Plus Oral Antidepressant Treatment for Relapse Prevention in Patients With Treatment-Resistant Depression

Author

Daly, Ella J., primary, Trivedi, Madhukar H., additional, Janik, Adam, additional, Li, Honglan, additional, Zhang, Yun, additional, Li, Xiang, additional, Lane, Rosanne, additional, Lim, Pilar, additional, Duca, Anna R., additional, Hough, David, additional, Thase, Michael E., additional, Zajecka, John, additional, Winokur, Andrew, additional, Divacka, Ilona, additional, Fagiolini, Andrea, additional, Cubala, Wieslaw J., additional, Bitter, István, additional, Blier, Pierre, additional, Shelton, Richard C., additional, Molero, Patricio, additional, Manji, Husseini, additional, Drevets, Wayne C., additional, and Singh, Jaskaran B., additional

Published
2019
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28. Efficacy and Safety of Fixed-Dose Esketamine Nasal Spray Combined With a New Oral Antidepressant in Treatment-Resistant Depression: Results of a Randomized, Double-Blind, Active-Controlled Study (TRANSFORM-1)

Author

Fedgchin, Maggie, primary, Trivedi, Madhukar, additional, Daly, Ella J, additional, Melkote, Rama, additional, Lane, Rosanne, additional, Lim, Pilar, additional, Vitagliano, Dawn, additional, Blier, Pierre, additional, Fava, Maurizio, additional, Liebowitz, Michael, additional, Ravindran, Arun, additional, Gaillard, Raphael, additional, Ameele, Hans Van Den, additional, Preskorn, Sheldon, additional, Manji, Husseini, additional, Hough, David, additional, Drevets, Wayne C, additional, and Singh, Jaskaran B, additional

Published
2019
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29. Randomized, Double-Blind Study of Fixed-Dose Intranasal Esketamine Plus Oral Antidepressant vs. Active Control in Treatment-Resistant Depression

Author

Fedgchin, Maggie, primary, Trivedi, Madhukar, additional, Daly, Ella J., additional, Melkote, Rama, additional, Lane, Rosanne, additional, Lim, Pilar, additional, Vitagliano, Dawn, additional, Blier, Pierre, additional, Fava, Maurizio, additional, Liebowitz, Michael, additional, Ravindran, Arun, additional, Gaillard, Raphael, additional, Ameele, Hans van den, additional, Manjii, Husseini, additional, Hough, David, additional, Drevets, Wayne C., additional, and Singh, Jaskaran B., additional

Published
2019
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30. Efficacy and Safety of Flexibly Dosed Esketamine Nasal Spray Combined With a Newly Initiated Oral Antidepressant in Treatment-Resistant Depression: A Randomized Double-Blind Active-Controlled Study

Author

Popova, Vanina, primary, Daly, Ella J., additional, Trivedi, Madhukar, additional, Cooper, Kimberly, additional, Lane, Rosanne, additional, Lim, Pilar, additional, Mazzucco, Christine, additional, Hough, David, additional, Thase, Michael E., additional, Shelton, Richard C., additional, Molero, Patricio, additional, Vieta, Eduard, additional, Bajbouj, Malek, additional, Manji, Husseini, additional, Drevets, Wayne C., additional, and Singh, Jaskaran B., additional

Published
2019
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31. EFFICACY AND SAFETY OF ESKETAMINE NASAL SPRAY PLUS AN ORAL ANTIDEPRESSANT IN ELDERLY PATIENTS WITH TREATMENT-RESISTANT DEPRESSION

Author

Ochs-Ross, Rachel, primary, Daly, Ella J., additional, Zhang, Yun, additional, Lane, Rosanne, additional, Lim, Pilar, additional, Foster, Karen, additional, Hough, David, additional, Manji, Husseini, additional, Drevets, Wayne C., additional, Sanacora, Gerard, additional, Adler, Caleb, additional, McShane, Rupert, additional, Gaillard, Raphaël, additional, and Singh, Jaskaran B., additional

Published
2019
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32. POST HOC ANALYSES OF ESKETAMINE NASAL SPRAY PLUS AN ORAL ANTIDEPRESSANT IN ELDERLY PATIENTS WITH TREATMENT-RESISTANT DEPRESSION

Author

Ochs-Ross, Rachel, primary, Daly, Ella J., additional, Zhang, Yun, additional, Lane, Rosanne, additional, Lim, Pilar, additional, Foster, Karen, additional, Hough, David, additional, Manji, Husseini, additional, Drevets, Wayne C., additional, Sanacora, Gerard, additional, Adler, Caleb, additional, McShane, Rupert, additional, Gaillard, Raphaël, additional, and Singh, Jaskaran B., additional

Published
2019
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33. Efficacy and Safety of Intranasal Esketamine for the Rapid Reduction of Symptoms of Depression and Suicidality in Patients at Imminent Risk for Suicide: Results of a Double-Blind, Randomized, Placebo-Controlled Study

Author

Canuso, Carla M., primary, Singh, Jaskaran B., additional, Fedgchin, Maggie, additional, Alphs, Larry, additional, Lane, Rosanne, additional, Lim, Pilar, additional, Pinter, Christine, additional, Hough, David, additional, Sanacora, Gerard, additional, Manji, Husseini, additional, and Drevets, Wayne C., additional

Published
2019
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34. Efficacy and Safety of Intranasal Esketamine for the Rapid Reduction of Symptoms of Depression and Suicidality in Patients at Imminent Risk for Suicide: Results of a Double-Blind, Randomized, Placebo-Controlled Study

Author

Canuso, Carla M., primary, Singh, Jaskaran B., additional, Fedgchin, Maggie, additional, Alphs, Larry, additional, Lane, Rosanne, additional, Lim, Pilar, additional, Pinter, Christine, additional, Hough, David, additional, Sanacora, Gerard, additional, Manji, Husseini, additional, and Drevets, Wayne C., additional

Published
2018
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36. S114. Efficacy and Safety of Intranasal Esketamine Plus an Oral Antidepressant in Elderly Patients With Treatment-Resistant Depression

Author

Ochs-Ross, Rachel, primary, Daly, Ella J., additional, Zhang, Yun, additional, Lane, Rosanne, additional, Lim, Pilar, additional, Foster, Karen, additional, Hough, David, additional, Manji, Husseini, additional, Drevets, Wayne C., additional, Sanacora, Gerard, additional, Adler, Caleb, additional, McShane, Rupert, additional, Gaillard, Raphaël, additional, and Singh, Jaskaran B., additional

Published
2018
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37. Intravenous Esketamine in Adult Treatment-Resistant Depression: A Double-Blind, Double-Randomization, Placebo-Controlled Study

Author

Singh, Jaskaran B., primary, Fedgchin, Maggie, additional, Daly, Ella, additional, Xi, Liwen, additional, Melman, Caroline, additional, De Bruecker, Geert, additional, Tadic, Andre, additional, Sienaert, Pascal, additional, Wiegand, Frank, additional, Manji, Husseini, additional, Drevets, Wayne C., additional, and Van Nueten, Luc, additional

Published
2016
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38. A Double-Blind, Randomized, Placebo-Controlled, Dose-Frequency Study of Intravenous Ketamine in Patients With Treatment-Resistant Depression

Author

Singh, Jaskaran B., primary, Fedgchin, Maggie, additional, Daly, Ella J., additional, De Boer, Peter, additional, Cooper, Kimberly, additional, Lim, Pilar, additional, Pinter, Christine, additional, Murrough, James W., additional, Sanacora, Gerard, additional, Shelton, Richard C., additional, Kurian, Benji, additional, Winokur, Andrew, additional, Fava, Maurizio, additional, Manji, Husseini, additional, Drevets, Wayne C., additional, and Van Nueten, Luc, additional

Published
2016
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41. Comparison of Long-Term Efficacy and Safety of Esketamine Nasal Spray Plus Oral Antidepressant in Younger Versus Older Patients With Treatment-Resistant Depression: Post-Hoc Analysis of SUSTAIN-2, a Long-Term Open-Label Phase 3 Safety and Efficacy Study

Author

Ochs-Ross, Rachel, Wajs, Ewa, Daly, Ella J., Zhang, Yun, Lane, Rosanne, Lim, Pilar, Drevets, Wayne C., Steffens, David C., Sanacora, Gerard, Jamieson, Carol, Hough, David, Manji, Husseini, and Singh, Jaskaran B.

Abstract

•What is the primary question addressed by this study?•Is there a difference in the response and safety profile of esketamine nasal spray treatment in younger (18–64 years) versus older (≥65 years) patients with treatment-resistant depression (TRD) within a long-term open-label study?•What is the main finding of the study?•This post-hoc analysis of SUSTAIN-2, a long-term, open-label, phase 3 study of esketamine nasal spray plus an oral antidepressant, showed comparable efficacy outcomes including change from baseline in MADRS total scores, and response and remission rates between younger and older patients with TRD. Safety and tolerability findings were also consistent between younger and older patients with TRD.•What is the meaning of the finding?•In this post-hoc analysis, treatment with esketamine nasal spray showed similar improvement in depression between younger and older adult patients with TRD, with consistent safety outcomes between the two age groups. Further controlled studies are warranted to substantiate these findings.

Published
2021
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43. Effects of the selective AMPA modulator NBI-1065845 on the pharmacokinetics of midazolam or ethinyl estradiol-levonorgestrel in healthy adults.

Author

Lin S, Ionescu A, Maynard-Scott J, Kennedy M, Walling DP, Furey M, and Singh JB

Subjects
Humans, Female, Adult, Male, Young Adult, Drug Interactions, Drug Combinations, Healthy Volunteers, Adolescent, Cytochrome P-450 CYP3A metabolism, Middle Aged, Area Under Curve, Cytochrome P-450 CYP3A Inducers administration & dosage, Cytochrome P-450 CYP3A Inducers pharmacology, Midazolam pharmacokinetics, Midazolam administration & dosage, Ethinyl Estradiol pharmacokinetics, Ethinyl Estradiol administration & dosage, Ethinyl Estradiol adverse effects, Contraceptives, Oral, Combined administration & dosage, Contraceptives, Oral, Combined pharmacokinetics, Levonorgestrel pharmacokinetics, Levonorgestrel administration & dosage, Levonorgestrel adverse effects
Abstract

This parallel-arm, phase I study investigated the potential cytochrome P450 (CYP)3A induction effect of NBI-1065845 (TAK-653), an investigational α-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid receptor potentiator in phase II development for major depressive disorder. The midazolam treatment arm received the sensitive CYP3A substrate midazolam on Day 1, followed by NBI-1065845 alone on Days 5-13; on Day 14, NBI-1065845 was administered with midazolam, then NBI-1065845 alone on Day 15. The oral contraceptive treatment arm received ethinyl estradiol-levonorgestrel on Day 1, then NBI-1065845 alone on Days 5-13; on Day 14, NBI-1065845 was administered with ethinyl estradiol-levonorgestrel, then NBI-1065845 alone on Days 15-17. Blood samples were collected for pharmacokinetic analyses. The midazolam treatment arm comprised 14 men and 4 women, of whom 16 completed the study. Sixteen of the 17 healthy women completed the oral contraceptive treatment arm. After multiple daily doses of NBI-1065845, the geometric mean ratios (GMRs) (90% confidence interval) for maximum observed concentration were: midazolam, 0.94 (0.79-1.13); ethinyl estradiol, 1.00 (0.87-1.15); and levonorgestrel, 0.99 (0.87-1.13). For area under the plasma concentration-time curve (AUC) from time 0 to infinity, the GMRs were as follows: midazolam, 0.88 (0.78-0.98); and ethinyl estradiol, 1.01 (0.88-1.15). For levonorgestrel, the GMR for AUC from time 0 to the last quantifiable concentration was 0.87 (0.78-0.96). These findings indicate that NBI-1065845 is not a CYP3A inducer and support its administration with CYP3A substrates. NBI-1065845 was generally well tolerated, with no new safety signals observed after coadministration of midazolam, ethinyl estradiol, or levonorgestrel., (© 2024 The Authors. Clinical and Translational Science published by Wiley Periodicals LLC on behalf of American Society for Clinical Pharmacology and Therapeutics.)

Published
2024
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