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      string(254) "NCT02418585 - A Randomized, Double-blind, Multicenter, Active-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Flexible Doses of Intranasal Esketamine Plus an Oral Antidepressant in Adult Subjects With Treatment-resistant Depression"
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      string(251) "NCT02417064 - A Randomized, Double-blind, Multicenter, Active-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Fixed Doses of Intranasal Esketamine Plus an Oral Antidepressant in Adult Subjects With Treatment-resistant Depression"
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  ["project_title"]=>
  string(113) "Personalized Ketamine Dosing: A Population PK/Pharmacogenomic Model Using Participant-Level Esketamine Trial Data"
  ["project_narrative_summary"]=>
  string(769) "Major depressive disorder and treatment-resistant depression remain leading causes of disability. Ketamine and esketamine offer rapid antidepressant effects but show wide variability in clinical response and acute adverse events, largely driven by pharmacokinetic and pharmacogenomic differences. This project will use participant-level data from esketamine clinical trials to build a predictive model linking dose, CYP2B6/CYP3A4 activity, patient characteristics, and exposure–response outcomes. The goal is to develop a transparent, evidence-based framework for individualized ketamine dosing that enhances safety and effectiveness. This work may ultimately inform precision-medicine approaches and improve outcomes for patients receiving ketamine-based treatments."
  ["project_learn_source"]=>
  string(9) "colleague"
  ["principal_investigator"]=>
  array(7) {
    ["first_name"]=>
    string(4) "Sai "
    ["last_name"]=>
    string(3) "Sun"
    ["degree"]=>
    string(3) "PhD"
    ["primary_affiliation"]=>
    string(17) "Tohoku University"
    ["email"]=>
    string(23) "sun.sai.e2@tohoku.ac.jp"
    ["state_or_province"]=>
    string(6) "Miyagi"
    ["country"]=>
    string(5) "Japan"
  }
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  ["project_ext_grants"]=>
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    ["value"]=>
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    ["label"]=>
    string(65) "External grants or funds are being used to support this research."
  }
  ["project_date_type"]=>
  string(18) "full_crs_supp_docs"
  ["property_scientific_abstract"]=>
  string(1323) "Background: Esketamine is an FDA-approved treatment for TRD, yet patients exhibit substantial heterogeneity in exposure, dissociation, BP elevations, and antidepressant response. Pharmacokinetic variation—including contributions from CYP2B6, CYP3A4, and patient covariates—plays a major role.

Objective: To evaluate exposure–response relationships and develop a personalized ketamine/esketamine dosing model based on participant-level data.

Study Design: Retrospective individual-participant analysis of esketamine clinical trials requested from the YODA Project.

Participants: Adult subjects enrolled in the selected esketamine randomized or open-label trials.

Primary Outcome Measures: (1) Exposure metrics (Cmax, AUC) generated from population PK modeling; (2) antidepressant response at 24h and 7 days; (3) acute safety outcomes (BP, dissociation, adverse events).

Secondary Outcome Measures: Associations between CYP2B6/CYP3A4 genotypes, covariates, and PK parameters.

Statistical Analysis: Develop a population PK model incorporating demographic, clinical, and genotypic covariates. Fit multivariable models (logistic, linear, or hierarchical) to relate exposure to efficacy/safety outcomes. Validate using cross-validation within the secure YODA computing environment."
  ["project_brief_bg"]=>
  string(1494) "Ketamine and esketamine represent major advances for treatment-resistant depression, yet clinical outcomes vary markedly across individuals. Key drivers of variability include differences in hepatic metabolism—particularly via CYP2B6 and CYP3A4—body weight, age, sex, co-medications, and comorbidities. Understanding how these factors alter ketamine exposure and downstream pharmacodynamic effects is essential for designing safer and more effective dosing strategies.

While several population pharmacokinetic (PopPK) models have been published for esketamine, these models were developed either in healthy volunteers or within limited clinical contexts. Few studies integrate patient-level PK/PD outcomes, genetic variation, and safety signals simultaneously. As ketamine and esketamine usage expands clinically, clinicians lack a validated framework to tailor dosing to individual risk and expected benefit.

The proposed study directly addresses this gap. Using participant-level data from esketamine trials made available through the YODA Project, we will (1) quantify covariate effects on exposure, (2) map exposure to antidepressant response, and (3) characterize the risk of dissociation and BP elevations. This information will be used to construct a precision-dosing model to improve individualized ketamine/esketamine treatment strategies. Findings will materially advance scientific understanding of ketamine pharmacology and support safer real-world implementation."
  ["project_specific_aims"]=>
  string(959) "Aim 1: Develop a population PK model for esketamine using participant-level data, estimating typical clearance, volume, and covariate effects (CYP2B6, CYP3A4, weight, age, sex, co-medications).

Aim 2: Quantify exposure–response relationships by relating predicted exposure metrics (Cmax, AUC) to antidepressant response at 24h and 7 days.

Aim 3: Quantify exposure–safety relationships linking exposure to dissociation, BP changes, and adverse events.

Aim 4: Integrate PK, pharmacogenomic, and clinical covariates into an individualized dosing framework to estimate safe and effective dose ranges.



Hypotheses:

1.CYP2B6/CYP3A4 activity significantly alters esketamine exposure.

2.Higher exposure is associated with increased dissociation but also greater likelihood of antidepressant response. (Hypertension)

3.A combined PK-PGx model can meaningfully stratify patients by predicted benefit and risk."
  ["project_study_design"]=>
  array(2) {
    ["value"]=>
    string(14) "indiv_trial_an"
    ["label"]=>
    string(25) "Individual trial analysis"
  }
  ["project_purposes"]=>
  array(4) {
    [0]=>
    array(2) {
      ["value"]=>
      string(56) "new_research_question_to_examine_treatment_effectiveness"
      ["label"]=>
      string(114) "New research question to examine treatment effectiveness on secondary endpoints and/or within subgroup populations"
    }
    [1]=>
    array(2) {
      ["value"]=>
      string(49) "new_research_question_to_examine_treatment_safety"
      ["label"]=>
      string(49) "New research question to examine treatment safety"
    }
    [2]=>
    array(2) {
      ["value"]=>
      string(37) "develop_or_refine_statistical_methods"
      ["label"]=>
      string(37) "Develop or refine statistical methods"
    }
    [3]=>
    array(2) {
      ["value"]=>
      string(50) "research_on_clinical_prediction_or_risk_prediction"
      ["label"]=>
      string(50) "Research on clinical prediction or risk prediction"
    }
  }
  ["project_research_methods"]=>
  string(642) "Data Source: Participant-level data from selected esketamine trials requested via the YODA Project.

Inclusion Criteria:

All adult participants enrolled in the selected YODA-provided esketamine clinical trials.

Participants with available dosing, clinical outcomes, and covariate data.

Exclusion Criteria:

Participants missing key PK-relevant variables (e.g., dose or outcome).

Participants withdrawn prior to receiving any esketamine dose.

No external datasets will be uploaded unless allowed under the YODA Data Use Agreement and accompanied by documented rights to use that data."
  ["project_main_outcome_measure"]=>
  string(475) "Primary Outcomes:

1.Exposure metrics: model-predicted Cmax and AUC for esketamine.

2.Antidepressant response: change in MADRS or similar scale at 24 hours.

3.Acute safety reactions: dissociation scores, maximum systolic/diastolic BP, adverse events.

Secondary Outcomes:

Response at 7 days.

Exposure–covariate interactions.

PK parameter variability attributable to CYP2B6/CYP3A4 genotype, weight, and co-medications."
  ["project_main_predictor_indep"]=>
  string(247) "Esketamine dose (mg and mg/kg)

CYP2B6 genotype/activity score

CYP3A4 genotype/activity score

PopPK-derived exposure metrics (Cmax, AUC)

Definitions will align with trial variable formats in the YODA dataset."
  ["project_other_variables_interest"]=>
  string(353) "Age, sex, weight, BMI

Baseline depression severity

Co-medications (SSRIs/SNRIs, benzodiazepines, CYP inducers/inhibitors)

Comorbidities (hypertension, anxiety disorders)

Ethnicity

Prior treatment history

Baseline vital signs

All variables will be coded using standardized categories."
  ["project_stat_analysis_plan"]=>
  string(946) "Descriptive statistics will summarize baseline characteristics.

PopPK modeling will use nonlinear mixed-effects methods (FOCEI, SAEM, or equivalent). Models will assess covariate effects using forward-addition/backward-elimination guided by AIC/BIC and clinical plausibility.

Exposure–response analyses will use:

Linear or logistic regression (ΔMADRS at 24h/7d).

Mixed-effects models accounting for repeated measurements when applicable.

Nonlinear Emax models for exposure–dissociation relationships.

Interaction terms for genotype × dose and genotype × exposure.

Exposure–safety analyses will use logistic regression for acute risks (e.g., BP > threshold, dissociation above prespecified scale cutoffs). Model performance will be assessed using AUROC, calibration curves, and sensitivity analyses. All modeling will be conducted within the YODA secure environment using R."
  ["project_software_used"]=>
  array(3) {
    [0]=>
    array(2) {
      ["value"]=>
      string(6) "python"
      ["label"]=>
      string(6) "Python"
    }
    [1]=>
    array(2) {
      ["value"]=>
      string(1) "r"
      ["label"]=>
      string(1) "R"
    }
    [2]=>
    array(2) {
      ["value"]=>
      string(7) "rstudio"
      ["label"]=>
      string(7) "RStudio"
    }
  }
  ["project_timeline"]=>
  string(435) "Project Start: Within 4 weeks of data access approval

Data Exploration & Cleaning: Months 1–2

PK Modeling: Months 2–4

Exposure–Response Modeling: Months 4–6

Manuscript Drafting: Months 7–9

Submission to Journal: Month 10

Reporting Results to YODA Project: Month 11–12

All work completed within the 12-month data access window (extensions if needed)."
  ["project_dissemination_plan"]=>
  string(476) "Findings will be disseminated via a peer-reviewed manuscript and presented at relevant psychiatry, pharmacology, and clinical pharmacometrics conferences. Target journals include: American Journal of Psychiatry, Clinical Pharmacology & Therapeutics, and Journal of Clinical Psychopharmacology. Results will also be shared with the YODA Project according to the Data Use Agreement and made available to the research community to support safe, evidence-based esketamine use."
  ["project_bibliography"]=>
  string(6414) "
Medeiros, G. C., Demo, I., Goes, F. S., Zarate Jr, C. A., & Gould, T. D. (2024). Personalized use of ketamine and esketamine for treatment-resistant depression. Translational psychiatry, 14(1), 481.
Sampogna, G., Toni, C., Catapano, P., Della Rocca, B., Di Vincenzo, M., Luciano, M., & Fiorillo, A. (2024). New trends in personalized treatment of depression. Current Opinion in Psychiatry, 37(1), 3-8.
Elmaadawi, A. Z., Naha, I., Prabhudesai, S., & Eltohami, M. (2025). Personalizing Ketamine Therapy: Real-World Predictors of Response to IV Ketamine and Intranasal Esketamine in Treatment-Resistant Depression. Psychiatry Research, 116821.
Veraart, J. K., Smith-Apeldoorn, S. Y., van der Meij, A., Spijker, J., Schoevers, R. A., & Kamphuis, J. (2025). Oral esketamine for patients with severe treatment-resistant depression: Effectiveness, safety, and tolerability of a six-week open-label treatment program. Journal of Psychopharmacology, 02698811251332831.
Janik, A., Qiu, X., Lane, R., Popova, V., Drevets, W. C., Canuso, C. M., … & Fu, D. J. (2025). Esketamine Monotherapy in Adults With Treatment-Resistant Depression: A Randomized Clinical Trial. JAMA psychiatry.
Swainson, J., Thomas, R. K., Archer, S., Chrenek, C., MacKay, M. A., Baker, G., … & Demas, M. L. (2019). Esketamine for treatment resistant depression. Expert review of neurotherapeutics, 19(10), 899-911.
Vasiliu, O. (2023). Esketamine for treatmentresistant depression: A review of clinical evidence. Experimental and therapeutic medicine, 25(3), 111.
Tonhajzerova, I., Visnovcova, Z., Ferencova, N., Kovacova, V., Farsky, I., & Ondrejka, I. (2025). Esketamine treatment: advances in personalized clinical monitoring. Bratislava Medical Journal, 1-8.
Huang, C., Hu, L., Liu, W., Geng, F., Wong, G. T. C., Zhang, Y., … & Lu, L. (2025). Efficacy and safety of esketamine on major depression, postpartum depression and perioperative depression: a systematic review and meta-analysis. Molecular Psychiatry, 1-14.
Bozymski, K. M., Crouse, E. L., Titus-Lay, E. N., Ott, C. A., Nofziger, J. L., & Kirkwood, C. K. (2020). Esketamine: a novel option for treatment-resistant depression. Annals of Pharmacotherapy, 54(6), 567-576.
Medeiros, G. C., Gould, T. D., Prueitt, W. L., Nanavati, J., Grunebaum, M. F., Farber, N. B., … & Goes, F. S. (2022). Blood-based biomarkers of antidepressant response to ketamine and esketamine: A systematic review and meta-analysis. Molecular psychiatry, 27(9), 3658-3669.
Nikayin, S., Murphy, E., Krystal, J. H., & Wilkinson, S. T. (2022). Long-term safety of ketamine and esketamine in treatment of depression. Expert opinion on drug safety, 21(6), 777-787.
Fountoulakis, K. N., Saitis, A., & Schatzberg, A. F. (2025). Esketamine treatment for depression in adults: a PRISMA systematic review and meta-analysis. American Journal of Psychiatry, 182(3), 259-275.
McIntyre, R. S., Rosenblat, J. D., Nemeroff, C. B., Sanacora, G., Murrough, J. W., Berk, M., … & Stahl, S. (2021). Synthesizing the evidence for ketamine and esketamine in treatment-resistant depression: an international expert opinion on the available evidence and implementation. American Journal of Psychiatry, 178(5), 383-399.
Reif, A., Bitter, I., Buyze, J., Cebulla, K., Frey, R., Fu, D. J., … & Godinov, Y. (2023). Esketamine nasal spray versus quetiapine for treatment-resistant depression. New England Journal of Medicine, 389(14), 1298-1309.
Daly, E. J., Singh, J. B., Fedgchin, M., Cooper, K., Lim, P., Shelton, R. C., … & Drevets, W. C. (2018). Efficacy and safety of intranasal esketamine adjunctive to oral antidepressant therapy in treatment-resistant depression: a randomized clinical trial. JAMA psychiatry, 75(2), 139-148.
Lima, T. D. M., Visacri, M. B., & Aguiar, P. M. (2022). Use of ketamine and esketamine for depression: an overview of systematic reviews with meta-analyses. European journal of clinical pharmacology, 78(3), 311-338.
Daly, E. J., Trivedi, M. H., Janik, A., Li, H., Zhang, Y., Li, X., … & Singh, J. B. (2019). Efficacy of esketamine nasal spray plus oral antidepressant treatment for relapse prevention in patients with treatment-resistant depression: a randomized clinical trial. JAMA psychiatry, 76(9), 893-903.
Yang, S., Wang, J., Li, X., Wang, T., Xu, Z., Xu, X., … & Chen, G. (2022). Adverse effects of esketamine for the treatment of major depression disorder: findings from randomized controlled trials. Psychiatric Quarterly, 93(1), 81-95.
Janik, A., Qiu, X., Lane, R., Popova, V., Drevets, W. C., Canuso, C. M., … & Fu, D. J. (2025). Esketamine Monotherapy in Adults With Treatment-Resistant Depression: A Randomized Clinical Trial. JAMA psychiatry.
Singh, J. B., Fedgchin, M., Daly, E., Xi, L., Melman, C., De Bruecker, G., … & Van Nueten, L. (2016). Intravenous esketamine in adult treatment-resistant depression: a double-blind, double-randomization, placebo-controlled study. Biological psychiatry, 80(6), 424-431.
Liu, P., Zhang, S. S., Liang, Y., Gao, Z. J., Gao, W., & Dong, B. H. (2022). Efficacy and safety of esketamine combined with antidepressants for treatment-resistant depression: a meta-analysis. Neuropsychiatric Disease and Treatment, 2855-2865.
Oraee, S., Alinejadfard, M., Golsorkh, H., Sadeghian, M., Fanaei, M., Centis, R., … & Nasiri, M. J. (2024). Intranasal esketamine for patients with major depressive disorder: A systematic review and meta-analysis. Journal of Psychiatric Research, 180, 371-379.
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