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  ["project_title"]=>
  string(147) "The Role of Placebo in Suicidal Ideation Outcomes in Ketamine and Esketamine Trials: Meta-Analyses of Comparative Effects, Active and Placebo Arms "
  ["project_narrative_summary"]=>
  string(707) "Ketamine and Esketamine are promising rapid-acting drugs studied for reducing suicidal thoughts in people with various psychiatric disorders. Both have demonstrated acute efficacy in prior clinical trials and meta-analyses, though their comparative effectiveness remains unclear. Direct head-to-head trials are lacking, and differences in observed effects may partly reflect variability in placebo response, which is known to be high in psychiatric trials and may vary with administration route or blinding quality. This study will conduct three meta-analyses: one comparing active drugs to placebo, one assessing only active arms, and one analyzing only placebo arms, to better interpret treatment effects."
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    ["first_name"]=>
    string(6) "Albino"
    ["last_name"]=>
    string(13) "Oliveira-Maia"
    ["degree"]=>
    string(12) "MD, PhD, MPH"
    ["primary_affiliation"]=>
    string(23) "Champalimaud Foundation"
    ["email"]=>
    string(35) "albino.maia@neuro.fchampalimaud.org"
    ["state_or_province"]=>
    string(6) "Lisbon"
    ["country"]=>
    string(8) "Portugal"
  }
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      ["p_pers_l_name"]=>
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      ["p_pers_degree"]=>
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      ["p_pers_pr_affil"]=>
      string(27) "Sapienza University of Rome"
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      ["p_pers_l_name"]=>
      string(7) "Seybert"
      ["p_pers_degree"]=>
      string(3) "PhD"
      ["p_pers_pr_affil"]=>
      string(23) "Champalimaud Foundation"
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      ["requires_data_access"]=>
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  ["project_ext_grants"]=>
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    ["label"]=>
    string(68) "No external grants or funds are being used to support this research."
  }
  ["project_date_type"]=>
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  ["property_scientific_abstract"]=>
  string(1607) "Background:

Ketamine and esketamine are emerging fast-acting treatment for reducing suicidal ideation across various psychiatric disorders. Multiple meta-analyses and systematic reviews have examined their efficacy, but none have directly analyzed how placebo effects may influence outcomes. Placebo responses are known to be high in psychiatric trials and may vary depending on factors like route of administration and unblinding. These variations may partly account for differences in observed treatment efficacy.

Objective: To evaluate the efficacy of ketamine and esketamine for suicidal ideation and investigate how placebo effects may contribute to observed treatment outcomes.

Study Design: 

Systematic review and three separate meta-analyses of RCTs:

(1) Active treatment (ketamine/esketamine) vs. placebo;

(2) Within-group effects in active arms only;

(3) Within-group effects in placebo arms only.

Participants:

Adults with DSM/ICD psychiatric diagnoses enrolled in RCTs comparing ketamine or esketamine to placebo.

Primary and Secondary Outcome Measures:

The primary outcome is change in suicidal ideation severity using validated scales (e.g., BSS, C-SSRS). Secondary outcomes include overall treatment response, incidence of adverse events in the placebo and active arms.

Statistical Analysis:

Random-effects meta-analyses using Hedge’s g for continuous outcomes. Between-study heterogeneity will be assessed using I2. Meta-regressions will examine drug , placebo type and study-level characteristics."
  ["project_brief_bg"]=>
  string(3133) "Ketamine and its S-enantiomer, esketamine, have been considered promising agents for suicide prevention in individuals with psychiatric disorders. Those compounds share a similar pharmacologic profiles and are generally administrated by different routes, and both have demonstrated rapid anti-suicidal effects within hours in clinical trials. Esketamine is integrated into clinical practice for treatment resistant depression with acute suicidal ideation, following FDA approval. Recent systematic reviews and meta-analyses have confirmed significant short-term efficacy for both agents compared to placebo [1][2]. However, esketamine appears to have a weaker efficacy than ketamine, decreasing after 24 hours. Evidence on long-term outcomes remains limited, due to substantial variability across trials and methodological concerns in existing RCTs, such as enrolling participants selected based on prior treatment response, which may overestimate effectiveness [3]. This uncertainty is compounded by the lack of randomized controlled trials (RCTs) that directly compare ketamine and esketamine for suicidal ideation, and difference in placebo response may contribute to variability in observed efficacy. Placebo effects vary across different psychiatric diagnosis [4] and are known to be particularly high for depressive symptoms in ketamine and esketamine studies [5]. Non-specific factors, such as patient expectation, frequency of provider interactions (that varies across inpatient and outpatient settings) may influence the outcomes. A participant-level meta-analysis focused on intravenous ketamine trials [6] found that placebo was associated with greater reductions in suicidal ideation than in other symptoms, suggesting that the placebo effect in suicidality may be particularly strong and mechanistically distinct. The difficulty in maintaining blinding, due to ketamine's dissociative effects, can lead to overestimate the drug's effects. In the case of ketamine and esketamine trials, these differences may contribute meaningfully to the apparent efficacy of the intervention, especially when comparing different intravenous vs. intranasal administration. This project will discuss these gaps by conducting three meta-analyses using data from RCTs of ketamine or esketamine for suicidal ideation: (1) comparing both active treatment to placebo, (2) analyzing only active treatment arms to estimate within-group change, and (3) analyzing only placebo arms to estimate the magnitude and variability of placebo response. Meta-regression techniques will be used to examine how drug, placebo characteristics and other variables influence observed treatment effects. By isolating and quantifying placebo response in these trials, this study aims to clarify the true clinical effect of ketamine and esketamine, improve interpretation of past and future RCTs, and support better design of trials that investigate rapid-acting treatments for suicidality. This work will generate generalizable scientific knowledge relevant to clinical trial methodology and the evaluation of psychiatric interventions with rapid onset of action."
  ["project_specific_aims"]=>
  string(1260) "The primary aim of this project is to evaluate the efficacy of ketamine and esketamine in reducing suicidal ideation (S.I.) in individuals with psychiatric disorders by disentangling drug-related effects from placebo responses.

Specific objectives include: (1) To compare both active vs placebo in reducing S.I. using data from randomized controlled trials. (2) To estimate treatment effects within active arms only (3) and placebo arms only. (4) To explore potential moderators of efficacy, such as drug-type, dosing, placebo type, number of sessions, setting (e.g. inpatient, outpatient), characteristics of the population (e.g. diagnosis, presence of S.I. baseline) (5) To estimate treatment response, side effects and dissociative effects across placebo and active arms.

Hypotheses: (1) Ketamine and esketamine will both show significant reductions in S.I. compared to placebo within 24 hours and their efficacy will decrease over time, especially for esketamine (2) Within-group changes will be observed in both active and placebo arms, but placebo responses will vary substantially across studies. (3)Placebo characteristics will moderate effect sizes and may explain some of the differences observed between ketamine and esketamine trials."
  ["project_study_design"]=>
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    ["label"]=>
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      ["label"]=>
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    }
    [1]=>
    array(2) {
      ["value"]=>
      string(52) "summary_level_data_meta_analysis_from_yoda_and_other"
      ["label"]=>
      string(69) "Meta-analysis using data from the YODA Project and other data sources"
    }
    [2]=>
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      ["value"]=>
      string(28) "research_on_comparison_group"
      ["label"]=>
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    }
  }
  ["project_research_methods"]=>
  string(1765) "The study was conducted in accordance with the recommendations of the Cochrane Handbook for Systematic Reviews of Interventions and the PRISMA reporting guidelines for systematic reviews. Searches were conducted in PubMed/MEDLINE, Embase, Web of Science, Cochrane Central, PsycINFO, and Scopus from database inception to November 2022 (with an updated search on September 2025), applying restrictions for human studies, adults, and language (English, Italian, Portuguese, German, and Spanish).



Inclusion criteria: (1) randomized controlled trials (RCTs) double or single blinded. Cross-over trials if pre-crossover data are available. When multiple publications report data from the same clinical trial, the version with the most complete outcome data will be selected. In multi-phase trials, only results from the unrestricted/randomized phase will be included. (2) Adult participants (≥18 years). (3) Diagnosis of a psychiatric disorder according to DSM / ICD criteria (any edition), confirmed trough structured/semi-structured interviews or trained clinicians. (4) Measure of suicidal ideation severity for baseline and at least one time point post-treatment with validated scales (e.g., MADRS item 10, C-SSRS) (5) Assignment to either active or placebo-controlled arms.

Interventions included ketamine or esketamine at subanesthetic doses, administered via any route.

Exclusion criteria: (1) Conference abstracts, letters, dissertations. (2) Healthy volunteers. (2) Trials not including a placebo arm. (4) Concomitant neuromodulatory or anesthetic treatments (e.g. ECT, TMS, DBS) (5) Studies focused solely on population of responders/remitters.

The screening was conducted using the platform Rayyan for systematic reviews "
  ["project_main_outcome_measure"]=>
  string(618) "Primary outcome: Change in suicidal ideation, from baseline to different timepoints, measured using validated clinician-administered scales (e.g. C-SSRS, MADRS-SI,HDRS-3, or SSI) and self-report scales (e.g. BSS, QIDS-SR16-12, SIDAS, others). Continuous scores will be extracted or derived (e.g., from SE, IQR, or graphical data) and standardized as standardized mean differences (SMD) across studies.

Secondary outcome: Response, defined as a ≥50% reduction from baseline in suicidal ideation score. Incidence of adverse effects, including dissociative symptoms, sedation, nausea, and cardiovascular changes."
  ["project_main_predictor_indep"]=>
  string(1115) "The main independent variable in this study is treatment assignment, defined by randomization to ketamine, esketamine, or placebo in eligible trials. This variable will be categorized as follows: (1) Ketamine (active): Patients randomized to receive ketamine via any route, regardless of dose, timing, or frequency. (2) Esketamine (active): Patients randomized to receive esketamine, typically via intranasal administration, according to trial protocol. Placebo: Patients randomized to receive an inert or active placebo control (e.g., saline IV, intranasal spray, or psychoactive comparator like midazolam used for blinding).

In analyses comparing treatment arms (meta-analysis #1), treatment assignment will be modeled as a categorical predictor (ketamine vs placebo; esketamine vs placebo). In indirect comparisons across studies, drug type (ketamine vs esketamine) will be included as a study-level moderator in meta-regression. In within-group meta-analyses (meta-analyses #2 and #3), treatment assignment will define which group-level estimates are pooled (e.g., active arms only vs placebo arms only)."
  ["project_other_variables_interest"]=>
  string(464) "In meta-regression, we will further explore treatment as a predictor of response while adjusting for moderators: dose, number of sessions, administration route, setting (inpatient or outpatient), diagnosis, presence of suicidal ideation baseline (acute or chronic, with or without intent), concomitant treatments, start of concomitant treatments (stable or newly initiated), prior exposure to ketamine or esketamine in other trials, presence of comorbid diagnosis."
  ["project_stat_analysis_plan"]=>
  string(2166) "The statistical analysis will be structured into three planned meta-analyses using randomized controlled trials (RCTs) data: (1) Comparative efficacy analysis (active drug vs placebo). (2) Within-group analysis of active arms. (3) Within-group analysis of placebo arms. We will describe baseline characteristics of participants in each trial and study arm, including age, sex, psychiatric diagnosis, baseline severity of suicidal ideation, comorbidities. Continuous variables will be summarized using means and standard deviations. Categorical variables will be summarized using frequencies and percentages. We will assess baseline balance between arms within each study using t-tests, chi-square tests, or non-parametric equivalents.

Comparative Meta-Analysis

For the primary analysis, we will calculate between-group effect sizes (SMD, Hedges’ g) for suicidal ideation change scores from baseline to different end-points, comparing ketamine or esketamine to placebo within each study. These will be pooled using a random-effects model (REML or DerSimonian–Laird) to account for between-study heterogeneity. Forest plots will be generated to visualize effect sizes, and heterogeneity will be assessed using I2, τ2, and Cochran’s Q statistics. We will analyze ketamine and esketamine trials both combined and separately, and perform an indirect comparison performing subgroup analyses and meta-regression.

Within-Group Meta-Analyses

Two separate random-effects meta-analyses will estimate pre–post effect sizes within active arms and placebo arms. These analyses will help quantify the absolute change in suicidal ideation in each condition. Meta-

regression models will assess the impact of moderators on observed effect sizes (for both comparative and within-arm analyses). Meta-regression will be performed using mixed-effects models, with robust variance estimation where appropriate. Sensitivity analyses will include alternative estimators, exclusion of trials at high risk of bias (based on Cochrane RoB tool) and fixed-effect models. We will assess potential publication bias using funnel plots and Egger’s test."
  ["project_software_used"]=>
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      ["label"]=>
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  ["project_timeline"]=>
  string(512) "The study is part of a larger project on clinical efficacy and effectiveness of classic and non-classic psychedelics with and without psychological support. Project start date: November 2022; meta-analysis already in progress and at the data extraction stage. Authors were contacted to request access to the missing data. Literature update: September 2025. Requesting data from additional studies trough YODA Project: October 2025. Data Analysis and results interpretation: 1 month. Manuscript Drafting: 1 month."
  ["project_dissemination_plan"]=>
  string(128) "This article will be submitted to high-impact medical journals,  such as Lancet Psychiatry and Jama Psychiatry, and conferences."
  ["project_bibliography"]=>
  string(1649) "
[1] Jollant F, Colle R, Nguyen TML et al. Ketamine and esketamine in suicidal thoughts and behaviors: a

systematic review. Ther Adv Psychopharmacol. 2023 Feb 7;13:20451253231151327. doi:

10.1177/20451253231151327.

[2] Feng W, Chen C, Zeng Y, Zhang B. Efficacy of single and repeated ketamine administration for suicidal

ideation in adults with psychiatric disorders: A meta-analysis. Prog Neuropsychopharmacol Biol Psychiatry.

2025 Jan 10;136:111152. doi: 10.1016/j.pnpbp.2024.111152.

[3] Plöderl, Martin & Cooper, Ruth & Walker et al. (2025). Effects of ketamine and esketamine on death,

suicidal behaviour, and suicidal ideation in psychiatric disorders: A systematic review and meta-analysis (Pre

print).

[4] Bschor T, Nagel L, Unger J et al. Differential Outcomes of Placebo Treatment Across 9 Psychiatric

Disorders: A Systematic Review and Meta-Analysis. JAMA Psychiatry. 2024 Aug 1;81(8):757-768. doi:

10.1001/jamapsychiatry.2024.0994.

[5] Matsingos A, Wilhelm M, Noor L et al. Hype or hope? High placebo response in major depression

treatment with ketamine and esketamine: a systematic review and meta-analysis. Front Psychiatry. 2024 Mar

8;15:1346697. doi: 10.3389/fpsyt.2024.1346697.

[6] Bloomfield-Clagett B, Ballard ED, Greenstein DK et al. A Participant-Level Integrative Data Analysis of

Differential Placebo Response for Suicidal Ideation and Nonsuicidal Depressive Symptoms in Clinical Trials of

Intravenous Racemic Ketamine. Int J Neuropsychopharmacol. 2022 Oct 25;25(10):827-838. doi: 10.1093/

ijnp/pyac055.
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    ["ID"]=>
    int(18891)
    ["id"]=>
    int(18891)
    ["title"]=>
    string(46) "YODA Project Protocol - 2025-0728 - 2026-03-09"
    ["filename"]=>
    string(46) "YODA-Project-Protocol-2025-0728-2026-03-09.pdf"
    ["filesize"]=>
    int(149714)
    ["url"]=>
    string(95) "https://yoda.yale.edu/wp-content/uploads/2025/10/YODA-Project-Protocol-2025-0728-2026-03-09.pdf"
    ["link"]=>
    string(88) "https://yoda.yale.edu/data-request/2025-0728/yoda-project-protocol-2025-0728-2026-03-09/"
    ["alt"]=>
    string(0) ""
    ["author"]=>
    string(4) "1885"
    ["description"]=>
    string(0) ""
    ["caption"]=>
    string(0) ""
    ["name"]=>
    string(42) "yoda-project-protocol-2025-0728-2026-03-09"
    ["status"]=>
    string(7) "inherit"
    ["uploaded_to"]=>
    int(18117)
    ["date"]=>
    string(19) "2026-03-10 14:54:33"
    ["modified"]=>
    string(19) "2026-03-10 14:54:33"
    ["menu_order"]=>
    int(0)
    ["mime_type"]=>
    string(15) "application/pdf"
    ["type"]=>
    string(11) "application"
    ["subtype"]=>
    string(3) "pdf"
    ["icon"]=>
    string(62) "https://yoda.yale.edu/wp/wp-includes/images/media/document.png"
  }
  ["project_review_link"]=>
  array(21) {
    ["ID"]=>
    int(18892)
    ["id"]=>
    int(18892)
    ["title"]=>
    string(36) "YODA Project Review - 2025-0728_site"
    ["filename"]=>
    string(38) "YODA-Project-Review-2025-0728_site.pdf"
    ["filesize"]=>
    int(1331827)
    ["url"]=>
    string(87) "https://yoda.yale.edu/wp-content/uploads/2025/10/YODA-Project-Review-2025-0728_site.pdf"
    ["link"]=>
    string(80) "https://yoda.yale.edu/data-request/2025-0728/yoda-project-review-2025-0728_site/"
    ["alt"]=>
    string(0) ""
    ["author"]=>
    string(4) "1885"
    ["description"]=>
    string(0) ""
    ["caption"]=>
    string(0) ""
    ["name"]=>
    string(34) "yoda-project-review-2025-0728_site"
    ["status"]=>
    string(7) "inherit"
    ["uploaded_to"]=>
    int(18117)
    ["date"]=>
    string(19) "2026-03-10 14:55:22"
    ["modified"]=>
    string(19) "2026-03-10 14:55:22"
    ["menu_order"]=>
    int(0)
    ["mime_type"]=>
    string(15) "application/pdf"
    ["type"]=>
    string(11) "application"
    ["subtype"]=>
    string(3) "pdf"
    ["icon"]=>
    string(62) "https://yoda.yale.edu/wp/wp-includes/images/media/document.png"
  }
  ["project_highlight_button"]=>
  string(0) ""
}
data partner
array(1) {
  [0]=>
  string(15) "johnson-johnson"
}


pi country
array(0) {
}


pi affil
array(0) {
}


products
array(1) {
  [0]=>
  string(8) "spravato"
}


num of trials
array(1) {
  [0]=>
  string(2) "13"
}


res
array(1) {
  [0]=>
  string(1) "3"
}