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      string(270) "NCT03434041 - A Randomized, Double-blind, Multicenter Active-controlled Study to Evaluate the Efficacy, Pharmacokinetics, 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(194) "nct03434041-a-randomized-double-blind-multicenter-active-controlled-study-to-evaluate-the-efficacy-pharmacokinetics-safety-and-tolerability-of-flexible-doses-of-intranasal-esketamine-plus-an-ora"
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  string(1718) "Background: Ketamine, an N-methyl-D-aspartate receptor (NMDAR) antagonist, is effective in patients with major depressive disorder (MDD) that are resistant to first-line therapies. Ketamine rapidly ameliorates depressive and suicidal symptoms. Preclinical literature suggests that there are sex differences in ketamine's effects, whereas this observation is inconsistent in clinical studies, although there is no meta-analysis.  

The incidence of MDD is much greater in females than males. For example, in Canada, MDD is diagnosed in 5.8% of women and 3.6% of men. Furthermore, suicidality, a common feature of MDD, was also discovered to vary by sex. The risk of suicide attempts is higher for females, but the incidence of completed attempts is higher for males. 

Given the variability in MDD symptomatology in males and females, as well as the disorder's greater frequency in females, it is vital to understand if ketamine's antidepressant and adverse side effects vary by sex.  

Objective: To evaluate whether female and male MDD patients respond differently to ketamine treatments, we aim to perform a meta-analysis of clinical trial data to determine if effectiveness, suicidality and adverse effects differ between male and female patients. 

Study Design: Meta-analysis of randomized clinical trials with data disaggregated by sex. 

Participants: MDD patients 18 years and older. Biological sex needs to be reported to be included in the meta-analysis. 

Primary and Secondary Outcome Measures: Primary outcome measures are the severity of depressive symptoms, suicidality scores and incidence of adverse effects. 

Statistical analyses: Meta-analysis using STATA."
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  string(2257) "Ketamine, an  N-methyl-D-aspartate receptor (NMDAR) antagonist, has been found to relieve depressive and suicidal symptoms in patients with treatment-resistant depression (TRD), a classification of major depressive disorder (MDD). TRD has been associated with greater severity, duration, likelihood of comorbid conditions and risk of recurrence. (Culpepper, 2013) MDD occurred in 5.8% of women and 3.6% of men in Canada in 2012. (Albert, 2015) Furthermore, it has been observed that suicidality, a common feature of MDD, was discovered to vary by sex. The risk of suicide attempts is higher for females but the incidence of completed attempts in higher for males. (DSM?5; American Psychiatric Association, 2013)

A literature review of the preclinical literature (Ponton et al., 2022) suggests that there are sex differences in ketamine's antidepressant effects, with females responding more strongly to ketamine than males in 10 out of 23 studies. This observation is inconsistent in clinical studies. A recent systematic review  of the clinical literature (Benitah et al., 2022) revealed  that only 4 out of 27 studies presented sex differences in ketamine antidepressant response, with females responding somewhat more strongly. Given the variability in suicidality in male and female MDD patients, as well as the disorder's greater frequency in females, it is vital to understand if ketamine's antidepressant features may vary by sex in the clinical framework.

Ketamine rapidly reduces depressive symptoms and suicidal thoughts in MDD and TRD patients, either in its racemic form or as one of its two enantiomers, esketamine (S+) and arketamine (R-). (Abdallah et al., 2015; Tizabi et al., 2012; Saland et al., 2017; Niciu et al., 2019) Nevertheless, there remains more to understand about ketamine, such as its mechanism of action, its effects on select symptoms of depressive disorders and how these features interact with biological sex. Clinical trials with esketamine contributed to the YODA Project are thus excellent data sets to implement in a meta-analysis designed to better understand whether the effectiveness of ketamine on depression scores and suicidality, as well as adverse effects, differ between male and female patients."
  ["project_specific_aims"]=>
  string(698) "The aim of this study is to determine if there are any sex differences in the antidepressant response to ketamine in clinical MDD samples, including suicidality and side effects. A meta-analysis and literature review is being performed to answer this question. Online scientific databases such as PubMed and PsycINFO were searched for studies using ketamine, with the strict requirement that results be split by sex for comparison purposes. Preclinical studies suggest that there is a greater sensitivity to ketamine in females than in males. We thus predict that female participants will have a greater response to ketamine in depressive symptom and suicidality alleviation than male participants."
  ["project_study_design"]=>
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    ["label"]=>
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  string(227) "Inclusion criteria are that ketamine needed to be administered strictly to MDD patients, data needed to be reported by sex, patients needed to be 18 years of age or older, and all studies needed to be randomized control trials."
  ["project_main_outcome_measure"]=>
  string(846) "There are three primary outcome measure for this study. The first is the severity of depressive symptoms following treatment, as assessed by questionnaires such as the Montgomery?sberg Depression Rating Scale (MADRS) and the Quick Inventory of Depressive Symptomatology ? Self-Report (QIDS-SR). The second primary outcome is suicidality scores (e.g., suicidal ideation, suicide attempts) following treatment, assessed by questionnaires like Beck's Scale for Suicidal Ideation (SSI) and the Clinical Global Impression of Severity of Suicidality Revised version (CGI-SS-r). The third primary outcome is the incidence of adverse effects (e.g., drowsiness, psychotomimetic symptoms such as hallucinations), following treatment, also assessed by questionnaires such as the Brief Psychiatric Rating Scale (BPRS) and the Young Mania Rating Scale (YMRS)."
  ["project_main_predictor_indep"]=>
  string(170) "The main independent variable for this study is participant biological sex. We will use self-report information from the original studies to classify participants by sex."
  ["project_other_variables_interest"]=>
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  ["project_stat_analysis_plan"]=>
  string(615) "All aim-relevant data extracted from studies will be graphed in STATA using a forest plot, which is to be disaggregated by sex. Funnel plots and the trim and fill method will then be generated to determine the severity of publication bias across all included studies. Afterwards, study influence will be assessed using the metainf command to discover which studies may be responsible for skewed meta-analysis outcomes. A new sex-disaggregated forest plot will then be generated excluding studies with high publication bias. All procedures listed will be performed three times for each of the three primary outcomes."
  ["project_timeline"]=>
  string(682) "Project start date: September 1, 2022; meta-analysis already in progress and at the data extraction stage. Eligible studies did not all disaggregate findings by sex and authors were contacted to request access to the data. One of these authors referred us to the YODA Project for requesting data from additional studies. The data requested from the YODA Project is to be included in the present meta-analysis.

Anticipated analysis completion date: April 15, 2023

Anticipated date manuscript drafted: May 31, 2023

Anticipated first submission for publication: July 1, 2023

Anticipated date for reporting results back to the YODA Project: September 1, 2023"
  ["project_dissemination_plan"]=>
  string(176) "We plan to write a manuscript with the meta-analysis results. This manuscript will be reposited in bioRxiv, then submitted for publication to an open access biomedical journal."
  ["project_bibliography"]=>
  string(2369) "
Abdallah, C. G., Salas, R., Jackowski, A., Baldwin, P., Sato, J. R., & Mathew, S. J. (2015). Hippocampal volume and the rapid antidepressant effect of ketamine. Journal of Psychopharmacology, 29(5), 591?595. https://doi.org/10.1177/0269881114544776

Albert, P. R. (2015). Why is depression more prevalent in women? Journal of Psychiatry and Neuroscience, 40(4), 219?221. https://doi.org/10.1503/jpn.150205

American Psychiatric Association. (2013). Diagnostic and statistical manual of mental disorders (5th ed.). https://doi.org/10.1176/appi.books.9780890425596

Benitah, K., Siegel, A. N., Lipsitz, O., Rodrigues, N. B., Meshkat, S., Lee, Y., Mansur, R. B., Nasri, F., Lui, L. M. W., McIntyre, R. S., & Rosenblat, J. D. (2022). Sex differences in ketamine?s therapeutic effects for mood disorders: A systematic review. Psychiatry Research, 312, 114579. https://doi.org/10.1016/j.psychres.2022.114579

Culpepper, L. (2013). Reducing the Burden of Difficult-to-Treat Major Depressive Disorder: Revisiting Monoamine Oxidase Inhibitor Therapy. The Primary Care Companion For CNS Disorders. https://doi.org/10.4088/PCC.13r01515

Niciu, M. J., Shovestul, B. J., Jaso, B. A., Farmer, C., Luckenbaugh, D. A., Brutsche, N. E., Park, L. T., Ballard, E. D., & Zarate, C. A. (2018). Features of dissociation differentially predict antidepressant response to ketamine in treatment-resistant depression. Journal of Affective Disorders, 232, 310?315. https://doi.org/10.1016/j.jad.2018.02.049

Ponton, E., Turecki, G., & Nagy, C. (2022). Sex Differences in the Behavioral, Molecular, and Structural Effects of Ketamine Treatment in Depression. International Journal of Neuropsychopharmacology, 25(1), 75?84. https://doi.org/10.1093/ijnp/pyab082

Saland, S. K., & Kabbaj, M. (2018). Sex Differences in the Pharmacokinetics of Low-dose Ketamine in Plasma and Brain of Male and Female Rats. Journal of Pharmacology and Experimental Therapeutics, 367(3), 393?404. https://doi.org/10.1124/jpet.118.251652

Tizabi, Y., Bhatti, B. H., Manaye, K. F., Das, J. R., & Akinfiresoye, L. (2012). Antidepressant-like effects of low ketamine dose is associated with increased hippocampal AMPA/NMDA receptor density ratio in female Wistar?Kyoto rats. Neuroscience, 213, 72?80. https://doi.org/10.1016/j.neuroscience.2012.03.052
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