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  ["project_title"]=>
  string(110) "Placebo Response Magnitude and Associated Factors in Randomized Double-Blind Trials of Ketamine for Depression"
  ["project_narrative_summary"]=>
  string(808) "Currently, studies on the placebo effect in depression mostly focus on traditional oral antidepressants. Little is known about how strong this effect is for new treatments like ketamine, which works differently and can have powerful rapid effects.  This study will analyze data from existing high-quality randomized double-blind trials, comparing ketamine to a placebo. The aims as follows:  first, to measure the exact size of the improvement seen in the placebo groups in larger samples of those ketamine trials; second, to explore what factors, including patient demographics, severity of depression and study sites, are associated with larger placebo effects. Thus,  this study is vital to accurately measure ketamine's true benefits and conduct better design in future studies for noval antidepressants."
  ["project_learn_source"]=>
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  ["principal_investigator"]=>
  array(7) {
    ["first_name"]=>
    string(8) "Shanshan"
    ["last_name"]=>
    string(4) "Tian"
    ["degree"]=>
    string(6) "Doctor"
    ["primary_affiliation"]=>
    string(51) "Beijing Anding Hospital, Capital Medical University"
    ["email"]=>
    string(29) "tianshanshan@mail.ccmu.edu.cn"
    ["state_or_province"]=>
    string(7) "Beijing"
    ["country"]=>
    string(5) "China"
  }
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    ["label"]=>
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  string(18) "full_crs_supp_docs"
  ["property_scientific_abstract"]=>
  string(1350) "Background: 

     Although placebo effects in oral antidepressants are well-studied, the extent and influencing factors of placebo effects in clinical trials of ketamine, a rapid-acting antidepressant with dissociative properties, remain unclear. This gap impedes accurate effect size estimation for novel rapid-acting antidepressants like ketamine.

Objective: 

      First, to quantify the extent of placebo effects in randomized double-blind trials of ketamine for depression. Second, to identify participant-level and trial-level influencing factors of placebo effects.

Study Design: 

    Secondary analysis of high-quality data from randomized double-blind trials of ketamine for depression.

Participants: 

    Adults (≥18 years) with major depressive disorder receiving placebo in clinical trials of ketamine.

Primary Outcome: 

    Standardized effect sizes of placebo effects from baseline to different endpoints, including day 1, week 1, week 4 and week 6.

Secondary Outcomes: 

    Influencing factors including baseline demographics, depression severity, number of inhalations, and trial design features.

Statistical Analysis: 

    Quantify effect size using Cohen’s d or Hedges’ g for outcomes, and multivariable regression to identify factors."
  ["project_brief_bg"]=>
  string(2622) "    Depression is the leading cause of mental-health-related disability worldwide, with an estimated global prevalence of 3.8%. It is prospectively associated with social dysfunctions, severe physical illness and suicide. As far, although antidepressants are still first-choice treatments for major depressive disorder (MDD), current antidepressants are limited by sole mechanism, slow-acting, and insufficient efficacy. Thus, the urgent clinical need, in combination with scientific advancements, government incentives and regulatory reforms, has driven robust development of novel antidepressants.

    The R&D process of new drug development is expensive and time-consuming, and the most cost and time-consuming process belong to the clinical trial phase. As we have known, it is an essential process to confirm the efficacy and safety of new drug. Thus, finding challenges of new drug and strategic solutions can be a method to successfully develop new drugs. In 1955, when the article entitled The Powerful Placebo was published, the placebo effect was acknowledged in its own right. The effects could mimic drug action, which obscure “true” drug effects and threaten to confound scientific research. That means that placebo effects often compromising the ability to detect statistically significant differences between active treatment and placebo conditions. Therefore, placebo effects are worthy of scientific investigation and those effects must be controlled through appropriate experimental design.

Placebo response varies significantly across different diseases, which is particularly pronounced in clinical trials for mental disorders. Recently, this meta-analysis compared placebo effects in 9 major psychiatric diagnoses with the strongest symptom reductions in MDD. In addition, placebo response rates over recent decades in clinical trials for MDD has progressively increasing at a rate of approximately 7% per decade, which become a critical challenge in psychopharmacology research.

    Ketamine is a rapid-acting antidepressant with dissociative properties, which is approved by FDA. In recent years, increasing number of clinical studies and trials have indicated that psychedelics may offer effective treatment for depression. Yet it remains unclear whether the observed effect sizes truly reflect the drugs’ pharmacological action. To date, there is no investigations have directly compared the magnitude of the placebo effect in psychedelic trials with that seen in conventional oral-antidepressant trials, making the present study both timely and significant.

"
  ["project_specific_aims"]=>
  string(530) "Our research has two primary aims. First, we will quantify the strength of the placebo response associated with psychedelic-based investigational drugs-ketamine. Second, we will identify the key factors, such as baseline characteristics, that influence this placebo response. By analyzing these variables, the study will provide empirical guidance for designing future psychedelic-antidepressant trials with more robust placebo controls, thereby facilitating the regulatory approval and safe introduction of novel antidepressants."
  ["project_study_design"]=>
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    ["label"]=>
    string(25) "Individual trial analysis"
  }
  ["project_purposes"]=>
  array(1) {
    [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"
    }
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  ["project_research_methods"]=>
  string(1550) "Inclusion Criteria:

1. Participants must have major depressive disorders with the diagnosis verified by a psychiatrist, according to the Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 diagnostic criteria.

2. Participants must have used at least one dose esketamine and was assessed at least one time after using esketamine.

3. Participants must have moderate to severe depression per clinical judgment.

Exclusion Criteria:

1. The participant's depressive symptoms have previously demonstrated nonresponse to Esketamine Nasal Spray or ketamine in the current major depressive episode per clinical judgment.

2. Participant has a current or prior DSM-5 diagnosis of a psychotic disorder or MDD with psychosis, bipolar or related disorders, comorbid obsessive- compulsive disorder, intellectual disability, borderline personality disorder, antisocial personality disorder, histrionic personality disorder, or narcissistic personality disorder.

3. Participant has a history of moderate or severe substance or alcohol use disorder according to DSM-5 criteria, except nicotine or caffeine, within 6 months before the start of the first dose.

4. A history (lifetime) of ketamine, phencyclidine (PCP), lysergic acid diethylamide (LSD), or 3, 4-methylenedioxy-methamphetamine (MDMA) hallucinogen-related use disorder is exclusionary.

5. Participants with a current or past history of seizures (uncomplicated childhood febrile seizures with no sequelae are not exclusionary).

"
  ["project_main_outcome_measure"]=>
  string(696) "Primary outcomes:

1. Change From Baseline to Day 1: 4-Hour, 1-Day, 1-Week, 2-Week, 3-Week, 4-week Post-dose in Montgomery Asberg Depression Rating Scale (MADRS) Total Score of placebo group.

2. Percentage of Participants With Response Based on MADRS Total Score at 4-Hour, 1-Day, 1-Week, 2-Week, 3-Week, 4-week Post-dose in placebo group.

Secondary outcomes:

1. The results of the relationship between all baseline characteristics and response rate (greater than or equal to (>=) 50% improvement from baseline in MADRS total score) in placebo group. 

2. Change From Baseline to Day 2 in Suicide Ideation and Behavior Assessment Tool in placebo group.

"
  ["project_main_predictor_indep"]=>
  string(101) "Baseline characteristics, like age, sex, MADRS score, suicide ideation and behavior,  race and so on."
  ["project_other_variables_interest"]=>
  string(112) "Number of study sites, doses, time of treatment, the method of allocation, blinding, analysis method and so on. "
  ["project_stat_analysis_plan"]=>
  string(2611) "Descriptive Analyses:

1. Participant Characteristics: Frequencies and percentages for categorical variables (e.g., sex, comorbidities, trial design features). Means and standard deviations (or medians and interquartile ranges for skewed data) for continuous variables (e.g., age, baseline MADRS score, number of inhalations) within the placebo group across all included trials.

2. Outcome Summaries: For each endpoint:

3. Mean (SD) / Median (IQR) of MADRS change from baseline (CFB) in the placebo group.

4. Proportion of placebo responders (≥50% MADRS reduction) with 95% confidence intervals (CIs).

5. Mean (SD) / Median (IQR) of Suicide Ideation and Behavior Assessment Tool CFB (Day 2).

6. Missing Data: Report the frequency and patterns of missing data for key variables and outcomes at each timepoint. 

Quantifying Placebo Effect Size

1. Effect Size Calculation: The standardized placebo effect (Hedges' *g*) will be calculated for the primary outcome at each pre-specified endpoint.

2. To account for repeated measures within participants and clustering within trials, Linear Mixed-Effects Models (LMMs) will be the primary analytical approach:

Multivariable Analyses:

1. Predictors: Variables showing suggestive association (p<0.10) in bivariate analyses or deemed clinically/theoretically relevant a priori (e.g., Baseline MADRS, Age, Sex, Number of Sessions/Inhalations, and others will be included. Interaction terms (e.g., Baseline_MADRS * Timepoint) will be explored.

2. Assessing if early placebo response (e.g., Day1 MADRS CFB) predicts later response (e.g., Wk4) using logistic regression within the placebo group.

3. Analysis of Baseline Factors and Response Rate Correlation, 

3.1 Categorical Baseline Variables (e.g., sex, race, comorbid diagnoses, prior medication history): Chi-square tests or Fisher's exact tests (if expected cell counts <5) will assess associations with response status (Responder/Non-responder) at each endpoint. Results will include odds ratios (OR) with 95% confidence intervals (CI).

3.2 Continuous Baseline Variables (e.g., age, baseline MADRS score, BMI, number of prior antidepressants): Point-biserial correlation or independent samples t-tests (for normally distributed variables) / Mann-Whitney U tests (for non-normal variables) will compare the distribution of continuous factors between Responders and Non-responders at each endpoint. Results will include correlation coefficients (r_pb) or difference in means/medians with 95% CI.

"
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      ["label"]=>
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  ["project_timeline"]=>
  string(435) "Project Start Date: Within 2 weeks of formal data receipt from YODA.

Data Preparation & Descriptive Analysis Completion: Month 2.

Primary & Secondary Analyses Completion: Month 5.

Advanced Analyses Completion: Month 7.

Manuscript First Draft Completed: Month 8.

Manuscript First Submitted for Publication: Month 9.

Summary Results Reported to YODA Project: Month 10-12.



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  string(852) "Primary Manuscript: Quantifying placebo effects and influencing factors in ketamine trials for depression.

Conference Presentations: Key findings at major psychiatry meetings (e.g., CSP, CPA).

Target Audiences:

1. Researchers (psychopharmacology, clinical trial design).

2. Regulatory agencies, pharmaceutical developers.

3. Clinicians 

Manuscript & Journals:

1. Primary Target: JAMA Psychiatry (scope: mechanistic clinical trials, high impact).

2. Alternatives: Neuropsychopharmacology (psychedelic mechanisms), Psychological Medicine (methodology/clinical relevance), or Journal of Affective Disorders.

Timeline: Submission within 9 months of data access (per milestone plan).

Open Access: Will comply with funder/YODA requirements; preprint on medRxiv pre-submission.

"
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pi country
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pi affil
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products
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num of trials
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res
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