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      string(244) "NCT04599855 - A Randomized, Double-blind, Multicenter, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Esketamine Nasal Spray, Administered as Monotherapy, in Adult Participants With Treatment-resistant Depression"
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      string(191) "nct04599855-a-randomized-double-blind-multicenter-placebo-controlled-study-to-evaluate-the-efficacy-safety-and-tolerability-of-esketamine-nasal-spray-administered-as-monotherapy-in-adult-part"
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  ["project_title"]=>
  string(51) "Nocebo effect in an esketamine trial for depression"
  ["project_narrative_summary"]=>
  string(856) "Several randomized controlled trials and real-world practices have established the effectiveness of esketamine’s antidepressant effects. Despite the evidence surrounding pharmacological effects of ketamine and esketamine, the influence of the placebo effect driving therapeutic effects is a popular topic of discussion. However, the inverse of the placebo effect, the expectation of a negative outcome from a treatment, also known as the “nocebo effect,” receives little attention yet potentially carries substantial clinical relevance. This project aims to examine the presence of the nocebo effect within an esketamine monotherapy trial for treatment-resistant depression, identify demographic and clinical variables associated with higher nocebo rates, and examine the association between nocebo effect, blinding integrity, and the placebo effect."
  ["project_learn_source"]=>
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    ["first_name"]=>
    string(5) "Peter"
    ["last_name"]=>
    string(8) "Giacobbe"
    ["degree"]=>
    string(2) "MD"
    ["primary_affiliation"]=>
    string(56) "University of Toronto, Sunnybrook Health Sciences Centre"
    ["email"]=>
    string(28) "peter.giacobbe@sunnybrook.ca"
    ["state_or_province"]=>
    string(7) "Ontario"
    ["country"]=>
    string(6) "Canada"
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      string(4) "Syed"
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      ["p_pers_pr_affil"]=>
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  ["project_ext_grants"]=>
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    ["label"]=>
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  ["property_scientific_abstract"]=>
  string(1641) "Background: Ketamine and esketamine are gaining interest for treatment-resistant depression. Studies implicate the placebo response in mediating therapeutic effects, but little attention has been given to the nocebo effect. The nocebo effect refers to negative effects following a treatment due to negative expectations, and has been observed across interventional psychiatry approaches like TMS, ECT and DBS, indicating that patients’ psychological states can influence treatment tolerability and response. Nevertheless, it remains unexplored for ketamine or esketamine.

Objective:1) Quantify the nocebo effect in an esketamine monotherapy trial for depression, defined as treatment-emergent adverse events and tolerability-related discontinuation in the placebo versus esketamine arm. 2) identify demographic and clinical variables associated with greater nocebo effect. 3) examine mediating relationships between blinding integrity, nocebo effect, and placebo effect

Study design: Secondary analysis on a randomized clinical trial

Participants: MDD patients aged ≥18 years

Primary and secondary outcome measures: Primary outcome is the proportion of participants reporting ≥1 AEs and proportion of study discontinuation due to AEs. Secondary outcomes include baseline characteristics and blinding integrity

Statistical analysis: Analyses will be conducted in R. Descriptive analysis include proportions and 95% Clopper Pearson intervals. Inferential analyses include chi-squared tests, linear regressions, causal mediation analysis, and Benjamini-Hochberg false discovery rate for multiple testing"
  ["project_brief_bg"]=>
  string(3237) "Ketamine and esketamine are effective for difficult-to-treat depression (Mathai et al., 2020; Huang et al., 2026). While studies link dissociation intensity to ketamine’s antidepressant efficacy (Niciu et al., 2018; Mello et al., 2021; Echegaray et al., 2025), others suggest that there is a considerable placebo effect underlying ketamine’s therapeutic effects (Matsingos et al., 2024). Although the placebo effect is a widely studied phenomenon in psychiatry and in the context of ketamine as well, little attention has been given to the nocebo effect. The nocebo effect is the case of experiencing negative effects following a treatment due to negative expectations surrounding the treatment (Colloca & Miller, 2011). Nocebo effects have been characterized across interventional psychiatry (Mestre et al., 2016; Zis et al., 2020; Braga et al., 2021). For instance, Zis and colleagues (2020) observed that the treatment discontinuation due to adverse events for TMS randomized controlled trials (RCTs) occurred at similar rates between sham and active groups. Our group has found that higher pre-TMS positive expectancy scores were significantly associated with greater antidepressant effects at the end of acute treatment, but negative expectations were not associated with decreased odds of remission or treatment discontinuation (Mollica et al., 2024). Reports have also discussed the presence of nocebo effects surrounding ECT within severely depressed patients and among those with negative expectations surrounding cognitive side effects (Krech et al., 2017; Sigström et al., 2020). Therefore, patient expectations can influence the treatment tolerability and response to neuromodulation treatments for depression, and may play a similar role for ketamine and esketamine treatments.



To study the nocebo effect, a trial must have an inactive placebo control and an active treatment arm with records of study discontinuation and treatment-emergent adverse events across both groups. First, the use of an inactive placebo is crucial, since the treatment-emergent adverse events following an inactive substance are reasonably assumed to occur due to psychological factors instead of pharmacological effects of an active placebo. Most RCTs for ketamine use a midazolam control, and thus are not ideal to study the nocebo effect. Additionally, clinical trials of esketamine initially paired the intervention with a newly initiated oral antidepressant, which also influences the accuracy of the observed nocebo effect. Finally, individual participant-level data is required in order to investigate the risk of nocebo effect across various demographic and baseline clinical presentations, and to identify relationships between participant-level blinding integrity, nocebo effect, and the strength of the placebo effect.



The YODA Project provides an ideal avenue for accessing the unique esketamine monotherapy clinical trial to conduct group- and participant-level analyses examining the nocebo effect, risk factors predisposing individuals to nocebo responses, and the potential interplay between nocebo and placebo effects, particularly as this relationship may be mediated by blinding integrity."
  ["project_specific_aims"]=>
  string(947) "The aim of this study is to examine the incidence of nocebo effect, defined as the reports of treatment-emergent adverse events among placebo receiving participants, in a placebo-controlled esketamine monotherapy trial for treatment-resistant depression.  Next, quantifying the proportion of adverse events reported by individuals in the placebo arm (i.e., nocebo effect) will then provide an estimate for the proportion of adverse events reported within the esketamine-receiving group which can be attributed to the nocebo, termed as the nocebo-attributable fraction.  Secondly, this project aims to examine whether any demographic or baseline clinical characteristics are linked to higher rates of experiencing the nocebo effect.  Thirdly, we aim to discern a relationship between blinding integrity and the nocebo effect, and investigate whether there is an interrelationship between these two variables and the placebo antidepressant response."
  ["project_study_design"]=>
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    ["label"]=>
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  ["project_purposes"]=>
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      ["value"]=>
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      ["label"]=>
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    [1]=>
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      ["label"]=>
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    [2]=>
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      ["label"]=>
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      ["label"]=>
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  ["project_research_methods"]=>
  string(350) "The data source is a placebo-controlled randomized clinical trial of esketamine monotherapy for treatment-resistant depression (NCT04599855).  Inclusion criteria for participants with MDD that have been enrollment in the selected trial, randomly assigned to either placebo or esketamine group, and are 18 years or older in age. No exclusion criteria."
  ["project_main_outcome_measure"]=>
  string(2030) "There are two primary outcomes for this study.  First, the nocebo effect will be measured as the proportion of participants in the placebo arm reporting ≥1 treatment-emergent adverse event reports and proportion of participants that drop-out of the study due to adverse effects.  Additionally, the nocebo-attributable factor for treatment-emergent adverse events within the esketamine group will be calculated as the proportion of placebo group participants with ≥1 adverse events divided by the proportion of esketamine group participants with ≥1 adverse events.  



Second, the presence and strength (i.e., greater number of reported adverse events) of the nocebo effect within the placebo arm will be examined in relation to the blinding integrity assessed through the Patient’s Awareness of Treatment-Arm Assignment Scale, which asks “Which medication did you receive?”  The correct response would be the participant stating “Placebo” and an incorrect response would be “Esketamine.”  Next, the presence and strength of the nocebo effect within the placebo arm will be examined in relation to the placebo effect (i.e., the extent of reduction in Montgomery–Åsberg Depression Rating Scale (MADRS) and the Quick Inventory of Depressive Symptomatology – Self-Report (QIDS-SR) scores from baseline to day 2 and day 28 of the study).  The interaction between nocebo and placebo response will be assessed by including blinding integrity response as a mediator variable.



The secondary outcome measures include the number of adverse events reported within the placebo arm examined in relation to baseline characteristics such as participant sex (categorical), age (continuous), and continuous clinical variables such as baseline depression symptom severity and duration of illness. Additional exploratory outcomes include quantifying the nocebo effect and the nocebo-attributable factor for specific adverse events such as dissociation, headaches, nausea, blurry vision and others."
  ["project_main_predictor_indep"]=>
  string(206) "The main independent variable is the treatment assignment (i.e., Placebo, 56 mg esketamine, or 84 mg esketamine).  The treatment-emergent adverse event burden will be analyzed based on treatment assignment."
  ["project_other_variables_interest"]=>
  string(781) "The main outcome variables are the proportion of individuals reporting ≥1 treatment-emergent adverse event, and the total treatment-emergent adverse event count within the placebo arm.  Study discontinuation/ drop-out due to adverse events will be recorded as a binary outcome.  The placebo antidepressant response is defined as the change in depression symptom scores from baseline to Day 2 and Day 28, as assessed by the MADRS and QIDS-SR.  The treatment-arm belief is assessed using the question posed to the participants “Which medication did you receive?”  Secondary analyses also include demographic (e.g., sex, age, ethnicity) and baseline clinical characteristics (e.g., depression severity, duration of illness) as independent variables predicting the nocebo burden."
  ["project_stat_analysis_plan"]=>
  string(1365) "All statistical analyses will be conducted in R.  The nocebo prevalence will be estimated as the proportion of treatment-emergent adverse events in the placebo arm, and the proportion of participants discontinuing the study due to adverse events.  Proportions and 95% Clopper Pearson intervals will be computed.  Chi-squared tests will be conducted to assess between-group differences in adverse events.  The nocebo-attributable fraction will be calculated as the ratio of placebo-arm to esketamine arm adverse events prevalence.  The nocebo-attributable fraction will be calculated separately for both esketamine dose groups (56 mg and 84 mg), and then a pooled esketamine arm.  Multiple testing will be corrected for using the Benjamini-Hochberg false discovery rate across all AE-specific comparisons.  Linear regressions will be conducted to examine the predictors of nocebo burden and results will be provided as odds ratios with 95% confidence intervals.  Among participants of the placebo arm, a causal mediation analysis will be conducted to investigate the relationship between nocebo burden (i.e., number of treatment-emergent adverse events in placebo group), treatment-arm belief (i.e., blinding integrity), and the placebo response (i.e., change in MADRS and QIDS-SR scores from baseline to Day 2 and Day 28), with treatment-arm belief as the mediator."
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  ["project_timeline"]=>
  string(318) "Assuming YODA Project proposal is approved by September 15th 2026:



Project start date: September 16th 2026

Anticipated analysis completion date: November 1st 2026

Anticipated manuscript complete draft date: December 15th 2026

Anticipated manuscript submission date: January 1st 2027"
  ["project_dissemination_plan"]=>
  string(286) "The results of this project are planned to be disseminated as presentations at academic conferences and events as well as an original research article publication in a biomedical journal. Potential journals include Neuropsychopharmacology, Psychological Medicine, and JAMA Network Open."
  ["project_bibliography"]=>
  string(3987) "
Braga, M., Barbiani, D., Emadi Andani, M., Villa-Sánchez, B., Tinazzi, M., & Fiorio, M. (2021). The role of expectation and beliefs on the effects of non-invasive brain stimulation. Brain Sciences, 11(11), 1526.
Colloca, L., & Miller, F. G. (2011). The nocebo effect and its relevance for clinical practice. Biopsychosocial Science and Medicine, 73(7), 598-603.
Echegaray, M. V., Mello, R. P., Magnavita, G. M., Leal, G. C., Correia-Melo, F. S., Jesus-Nunes, A. P., … & Quarantini, L. C. (2025). Does the intensity of dissociation predict antidepressant effects 24 hours after infusion of racemic ketamine or esketamine in treatment-resistant depression? A secondary analysis from a randomized controlled trial. Trends in Psychiatry and Psychotherapy, 47, e20220593.
Huang, C., Hu, L., Liu, W., Geng, F., Wong, G. T. C., Zhang, Y., … & Lu, L. (2026). Efficacy and safety of esketamine on major depression, postpartum depression and perioperative depression: a systematic review and meta-analysis. Molecular Psychiatry, 31(1), 545-558.
Krech, L., Belz, M., Besse, M., Methfessel, I., Wedekind, D., & Zilles, D. (2018). Influence of depressed patients’ expectations prior to electroconvulsive therapy on its effectiveness and tolerability (Exp-ECT): a prospective study. European Archives of Psychiatry and Clinical Neuroscience, 268(8), 809-817.
Mathai, D. S., Meyer, M. J., Storch, E. A., & Kosten, T. R. (2020). The relationship between subjective effects induced by a single dose of ketamine and treatment response in patients with major depressive disorder: a systematic review. Journal of Affective Disorders, 264, 123-129.
Matsingos, A., Wilhelm, M., Noor, L., Yildiz, C., Rief, W., Hofmann, S. G., … & Kircher, T. (2024). Hype or hope? High placebo response in major depression treatment with ketamine and esketamine: a systematic review and meta-analysis. Frontiers in Psychiatry, 15, 1346697.
Mello, R. P., Echegaray, M. V., Jesus-Nunes, A. P., Leal, G. C., Magnavita, G. M., Vieira, F., … & Quarantini, L. C. (2021). Trait dissociation as a predictor of induced dissociation by ketamine or esketamine in treatment-resistant depression: secondary analysis from a randomized controlled trial. Journal of Psychiatric Research, 138, 576-583.
Mestre, T. A., Lang, A. E., & Okun, M. S. (2016). Factors influencing the outcome of deep brain stimulation: placebo, nocebo, lessebo, and lesion effects. Movement Disorders, 31(3), 290-298.
Mollica, A., Ng, E., Burke, M. J., Nestor, S. M., Lee, H., Rabin, J. S., … & Giacobbe, P. (2024). Treatment expectations and clinical outcomes following repetitive transcranial magnetic stimulation for treatment-resistant depression. Brain Stimulation, 17(4), 752-759.
Niciu, M. J., Shovestul, B. J., Jaso, B. A., Farmer, C., Luckenbaugh, D. A., Brutsche, N. E., … & Zarate Jr, C. A. (2018). Features of dissociation differentially predict antidepressant response to ketamine in treatment-resistant depression. Journal of affective disorders, 232, 310-315.
Sigström, R., Nordenskjöld, A., Juréus, A., Clements, C., Joas, E., Pålsson, E., & Landén, M. (2020). Long-term subjective memory after electroconvulsive therapy. BJPsych Open, 6(2), e26.
Zis, P., Shafique, F., Hadjivassiliou, M., Blackburn, D., Venneri, A., Iliodromiti, S., … & Sarrigiannis, P. G. (2020). Safety, tolerability, and nocebo phenomena during transcranial magnetic stimulation: a systematic review and meta-analysis of placebo-controlled clinical trials. Neuromodulation: Technology at the Neural Interface, 23(3), 291-300.
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    string(7) "inherit"
    ["uploaded_to"]=>
    int(19234)
    ["date"]=>
    string(19) "2026-09-29 20:09:03"
    ["modified"]=>
    string(19) "2026-09-29 20:09:03"
    ["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) ""
  ["request_data_partner"]=>
  string(0) ""
}
data partner
array(1) {
  [0]=>
  string(0) ""
}


pi country
array(0) {
}


pi affil
array(0) {
}


products
array(0) {
}


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


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