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  ["project_title"]=>
  string(134) "Safety Effect Moderators of Intranasal Esketamine used in Assocation with a SSRI or SNRI: An Individual Participant Data Meta-Analysis"
  ["project_narrative_summary"]=>
  string(798) "Depression that does not improve after at least two antidepressant treatments is called treatment-resistant depression. Intranasal esketamine is an approved treatment for these patients, but some people experience side effects such as dizziness, sedation, dissociation, or increases in blood pressure. This study will combine individual participant data from several high-quality clinical trials to investigate whether these side effects differ according to age, sex, blood pressure, or the type of antidepressant taken alongside esketamine (SSRI or SNRI). By identifying which groups of patients are more likely to experience adverse effects, this research aims to improve treatment safety, support more personalised care, and help clinicians and patients make better-informed treatment decisions."
  ["project_learn_source"]=>
  string(12) "scien_public"
  ["principal_investigator"]=>
  array(7) {
    ["first_name"]=>
    string(7) "Florian"
    ["last_name"]=>
    string(6) "Naudet"
    ["degree"]=>
    string(7) "MD, PhD"
    ["primary_affiliation"]=>
    string(17) "Rennes University"
    ["email"]=>
    string(23) "floriannaudet@gmail.com"
    ["state_or_province"]=>
    string(8) "Bretagne"
    ["country"]=>
    string(6) "France"
  }
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      ["p_pers_f_name"]=>
      string(11) "Mian Haider"
      ["p_pers_l_name"]=>
      string(3) "Ali"
      ["p_pers_degree"]=>
      string(13) "MA / MS / MSc"
      ["p_pers_pr_affil"]=>
      string(26) "LMU (University of Munich)"
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      string(10) "Burgwinkel"
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      string(20) "University of Zurich"
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      string(6) "Ka Hin"
      ["p_pers_l_name"]=>
      string(3) "Tai"
      ["p_pers_degree"]=>
      string(13) "MA / MS / MSc"
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      string(20) "University of Rennes"
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      string(7) "Tobechi"
      ["p_pers_l_name"]=>
      string(9) "Obinwanne"
      ["p_pers_degree"]=>
      string(7) "MA, Msc"
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      string(34) "University of Medicine, Goettingen"
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      ["p_pers_l_name"]=>
      string(4) "Held"
      ["p_pers_degree"]=>
      string(3) "PhD"
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      string(20) "University of Zurich"
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    ["value"]=>
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    ["label"]=>
    string(65) "External grants or funds are being used to support this research."
  }
  ["project_funding_source"]=>
  string(70) "Doctoral network MSCA-DN SHARE-CTD (HORIZON-MSCA-2022-DN-01 101120360)"
  ["project_date_type"]=>
  string(18) "full_crs_supp_docs"
  ["property_scientific_abstract"]=>
  string(1627) "Background: TRD is a severe and disabling condition associated with substantial morbidity, impaired quality of life, and increased mortality.

Objective: To determine whether age, sex, baseline hypertension, and concomitant antidepressant class (SSRI vs SNRI) modify the association between intranasal esketamine treatment and adverse events.

Study Design: Individual participant data meta-analysis (IPDMA) of double-blind, randomised, placebo-controlled clinical trials comparing intranasal esketamine plus an SSRI/SNRI with placebo plus an SSRI/SNRI.

Participants: Adults (≥18 years) with treatment-resistant depression who were esketamine-naïve and enrolled in eligible randomised controlled trials. Trials excluding participants with pre-existing hypertension will be excluded.

Outcome Measures: The primary outcome is the total number of treatment-emergent adverse events during the acute treatment phase, regardless of event type. Prespecified subgroup analyses will evaluate whether sex, age, baseline hypertension, or antidepressant class modify the association between treatment and adverse events.

Statistical Analysis: Separate one-stage individual participant data meta-analyses will be conducted for each prespecified moderator using mixed-effects negative binomial regression. Models will include treatment, moderator, and treatment-by-moderator interaction as fixed effects, trial as a random intercept, and esketamine dose as a covariate. Incidence rate ratios with 95% confidence intervals and interaction p-values will be reported. Age will be used as continuous variable."
  ["project_brief_bg"]=>
  string(2695) "Treatment-resistant depression (TRD) is a severe and disabling condition associated with substantial morbidity, impaired quality of life, and increased mortality. Despite the availability of conventional antidepressants, approximately one-third of patients fail to achieve an adequate response after multiple treatment attempts. Intranasal esketamine, administered in combination with an oral selective serotonin reuptake inhibitor (SSRI) or serotonin and norepinephrine reuptake inhibitor (SNRI), has become an important treatment option for adults with TRD because of its rapid antidepressant effects.



Although the efficacy of esketamine has been extensively studied, its safety profile remains an important clinical consideration. Common treatment-emergent adverse events (TEAEs), including dissociation, dizziness, sedation, nausea, transient increases in blood pressure, and cardiovascular events, may affect treatment acceptability, adherence, and clinical decision-making. Published trial reports and conventional meta-analyses primarily describe average treatment effects and aggregate safety outcomes, providing limited insight into whether the risk of adverse events differs according to patient characteristics such as age, sex, baseline hypertension, or concomitant antidepressant treatment.



Individual participant data meta-analysis (IPDMA) offers a unique opportunity to investigate treatment effect heterogeneity by analysing participant-level data across multiple randomised controlled trials. Previous IPDMAs of esketamine have focused predominantly on moderators of antidepressant efficacy, whereas potential moderators of safety outcomes have received comparatively little attention. Consequently, clinicians currently have limited evidence to identify which patients may be at increased risk of adverse events during acute esketamine treatment.



The proposed research will use participant-level data from randomised controlled trials of intranasal esketamine to evaluate whether age, sex, baseline hypertension, and concomitant antidepressant class (SSRI versus SNRI) modify the association between treatment and treatment-emergent adverse events. By identifying patient subgroups with differing safety profiles, this study will generate clinically relevant evidence to improve risk–benefit assessment, support treatment individualisation, inform clinical guidelines, and enhance shared decision-making between clinicians and patients. More broadly, the study will advance understanding of heterogeneity in treatment safety and contribute generalizable evidence to support the safe use of esketamine in routine clinical practice."
  ["project_specific_aims"]=>
  string(745) "While previous individual participant data meta-analyses (IPDMAs) have examined baseline clinical and demographic characteristics as moderators of esketamine efficacy, important gaps remain regarding whether treatment-emergent adverse events (TEAE) differ across patient subgroups (e.g., by age or sex). Evaluating potential effect moderators for safety outcomes is clinically important, as conventional aggregate safety reporting does not adequately capture individual-level heterogeneity in adverse event profiles or the clustering of therapeutic benefit and acute tolerability (Jones et al. 2022; Ochs-Ross et al. 2022). Our objective is to assess the subgroup-specific safety of intranasal esketamine using individual participant data (IPD)."
  ["project_study_design"]=>
  array(2) {
    ["value"]=>
    string(7) "meta_an"
    ["label"]=>
    string(52) "Meta-analysis (analysis of multiple trials together)"
  }
  ["project_purposes"]=>
  array(3) {
    [0]=>
    array(2) {
      ["value"]=>
      string(49) "new_research_question_to_examine_treatment_safety"
      ["label"]=>
      string(49) "New research question to examine treatment safety"
    }
    [1]=>
    array(2) {
      ["value"]=>
      string(22) "participant_level_data"
      ["label"]=>
      string(36) "Participant-level data meta-analysis"
    }
    [2]=>
    array(2) {
      ["value"]=>
      string(37) "participant_level_data_only_from_yoda"
      ["label"]=>
      string(51) "Meta-analysis using only data from the YODA Project"
    }
  }
  ["project_research_methods"]=>
  string(2016) "Participants, Interventions, Comparators, Outcomes, and Study Design (PICOS)

1	Participants

Studies that include esketamine naive participants with treatment resistant depression (TRD). Participants must be 18 years or older.

TRD refers to a depressive episode with inadequate response to at least two antidepressant trials of adequate doses and duration (i.e., have failed ≥ 2 adequate antidepressant trials).

2	Interventions

Intranasal esketamine in any dosage for the primary treatment of depression, administered with antidepressant.

3	Comparators

Placebo (a solution with a bittering agent added to simulate the taste of the esketamine solution) or active placebo, administered with antidepressant.

4	Study Outcomes

The primary outcome is the total number of TEAEs during the acute treatment phase (described as treatment phase / induction phase / blinded phase in trials), irrespective of event type. TEAEs relevant to the use of esketamine include dissociation, sedation, nausea, dizziness, vertigo, headache, abnormal heart rate (atrial fibrillation, extrasystoles, increased heart rate, palpitations, sinus tachycardia, tachycardia), hypertension (increased diastolic blood pressure, increased systolic blood pressure, increased blood pressure, hypertension, hypertensive crisis, hypertensive heart disease) and cardiovascular events (angina pectoris, cardiac failure acute, chest discomfort, chest pain (Ochs-Ross et al. 2022; Doherty et al. 2020; Nikayin and Sanacora 2022)).

The primary objective is to evaluate whether sex (binary: male/female), age (continuous), pre-existing hypertension condition (binary: normotensive, hypertensive) and associated anti-depressants (binary: SSRI vs. SNRI) moderate the association between treatment and adverse events.

5	Study Design

Double-blind, randomised, placebo-controlled trials. Trials that excluded participants with pre-existing hypertensive conditions will be excluded."
  ["project_main_outcome_measure"]=>
  string(1322) "An IPDMA derived from double-blind, randomised, placebo-controlled trials of esketamine in association with a selective serotonin reuptake inhibitor (SSRI) or a serotonin and norepinephrine reuptake inhibitor (SNRI) in patients with depression.



The primary outcome is the total number of TEAEs during the acute treatment phase (described as treatment phase / induction phase / blinded phase in trials), irrespective of event type. TEAEs relevant to the use of esketamine include dissociation, sedation, nausea, dizziness, vertigo, headache, abnormal heart rate (atrial fibrillation, extrasystoles, increased heart rate, palpitations, sinus tachycardia, tachycardia), hypertension (increased diastolic blood pressure, increased systolic blood pressure, increased blood pressure, hypertension, hypertensive crisis, hypertensive heart disease) and cardiovascular events (angina pectoris, cardiac failure acute, chest discomfort, chest pain (Ochs-Ross et al. 2022; Doherty et al. 2020; Nikayin and Sanacora 2022)).

The primary objective is to evaluate whether sex (binary: male/female), age (continuous), pre-existing hypertension condition (binary: normotensive, hypertensive) and associated anti-depressants (binary: SSRI vs. SNRI) moderate the association between treatment and adverse events.

"
  ["project_main_predictor_indep"]=>
  string(1094) "The primary objective is to evaluate whether sex, age, blood pressure or associated anti-depressants moderate the association between treatment and adverse events. The primary outcome will be analysed separately for each moderator using one-stage IPDMA.



Sex will be evaluated as a binary moderator (Male vs. Female). Baseline cardiovascular status will be evaluated as a binary moderator, classifying participants as hypertensive (Baseline systolic blood pressure ≥140 mmHg, diastolic blood pressure ≥90 mmHg, or documented history) versus normotensive. Concomitant anti-depressants will be evaluated as a binary class moderator (SSRI vs. SNRI), restricting the concomitant medication safety analysis to participants actively receiving these two primary background therapeutic classes at baseline to evaluate the differential impact of noradrenergic versus serotonergic reuptake inhibition on acute post-dose safety signals. Age will be modeled as a continuous moderator to retain maximum statistical power and use data from both adult (18–64) and geriatric (≥65) trials."
  ["project_other_variables_interest"]=>
  string(192) "As the primary outcome is a composite measure, we will also conduct separate analyses by adverse event type, including cardiovascular, neuropsychiatric, and other categories of adverse events."
  ["project_stat_analysis_plan"]=>
  string(2835) "The goal is to perform a secondary analysis of trials assessing the efficacy of esketamine, that is, to address a new research question using this existing dataset. Access to the clinical trial data is granted via the Yale University Open Data Access (YODA) project.



All analyses will be performed using R version 4.3.0 or higher. For the analysis, we will use R packages such as tidyverse, dplyr, meta, metafor, lme4, logistf, stringr, ordinal, lmerTest and ggplot2.



Separate one-stage mixed-effects negative binomial regression models will be fitted for each prespecified moderator. The outcome will be analysed using a one-stage mixed-effects negative binomial regression model. Treatment group, subgroup, i.e. the moderator, and the treatment subgroup interaction term will be included as fixed effects. The trial identifier will be included as a random intercept to account for clustering of participants within studies.

The continuous moderator age will be mean-centred across the pooled dataset prior to modelling. The interaction term ("Treatment"×" Age" ) will assess whether the association between treatment and the number of TEAEs varies with age. Age will be included as a continuous fixed effect together with the treatment group and the ("Treatment"×" Age" ) interaction term in the mixed-effects negative binomial model.

Incidence rate ratios, the corresponding 95% confidence intervals and p-values for the interaction terms will be reported for all moderators.

We will include dosage as a covariate. This covariate differentiates between different fixed dosages of esketamine, e.g. 56mg or 84mg and flexible dosage.

Primary to the analysis, the linearity assumption for continuous age moderator will be verified graphically.



Quality Control

Data extraction will follow a standardized process, including mapping trial-specific variables to harmonized analysis variables, cross-checking against protocols. Quality control procedures include range and consistency checks, verification of randomization assignments, assessment of completeness for key variables. All data cleaning steps will be scripted and documented.



Reproducibility

This statistical analysis plan will be uploaded to OSF. All code will be shared in accordance with the FAIR principles (Findable, Accessible, Interoperable, Reusable) and clear guidance will be made available for researchers seeking access to the data.



Changes from Protocol

Protocol Deviations

All deviations from the original trial protocols relevant to this IPDMA will be documented.



Statistical analysis plan Amendments

Any amendments to this statistical analysis plan will be dated, versioned, and justified prior to analysis."
  ["project_software_used"]=>
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    [0]=>
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      ["value"]=>
      string(1) "r"
      ["label"]=>
      string(1) "R"
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  ["project_timeline"]=>
  string(835) "This project is part of SHARE-CTD Datathon 3, in which three independent teams have developed three distinct research questions. The present submission is made by the Principal Investigator on behalf of the datathon. Each team will conduct its analyses separately and in isolation, ensuring independence of research questions, analytical approaches, and interpretation of results across teams.



This project will be conducted during September 2026 as part of the SHARE-CTD Datathon 3. The main analyses will be carried out between Monday, 7 September 2026, and Friday, 11 September 2026, during the datathon. Additional analyses, quality checks, and finalisation of the statistical analyses may continue later in September, if required. Manuscript preparation is expected to take place between September and October 2026."
  ["project_dissemination_plan"]=>
  string(205) "Results will be disseminated through peer-reviewed scientific publications, presentations at national and international conferences, and communication activities conducted as part of the SHARE-CTD project."
  ["project_bibliography"]=>
  string(1146) "
Doherty, Teodora, Ewa Wajs, Rama Melkote, Janice Miller, Jaskaran B Singh, and Michael A Weber. 2020. “Cardiac Safety of Esketamine Nasal Spray in Treatment-Resistant Depression: Results from the Clinical Development Program.” CNS Drugs 34 (3): 299–310.
Jones, Robyn R, Marlene P Freeman, Susan G Kornstein, et al. 2022. “Efficacy and Safety of Esketamine Nasal Spray by Sex in Patients with Treatment-Resistant Depression: Findings from Short-Term Randomized, Controlled Trials.” Archives of Women’s Mental Health 25 (2): 313–26.
Nikayin, Sina, and Gerard Sanacora. 2022. “Ketamine/Esketamine for Treatment-Resistant Depression.” In Managing Treatment-Resistant Depression. Elsevier.
Ochs-Ross, Rachel, Ewa Wajs, Ella J Daly, et al. 2022. “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.” The American Journal of Geriatric Psychiatry 30 (5): 541–56.
"
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