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  string(148) "Effects of ketamine and esketamine on death, suicidal behavior and suicidal ideation in psychiatric disorders: A systematic review and meta-analysis"
  ["project_narrative_summary"]=>
  string(677) "Ketamine and esketamine have been considered as innovative and powerful means to reduce depression and suicide risk in many studies. An updated review of the literature is lacking, however. In this research project we want to study the suicide preventive effect of ketamine and esketamine. Therefore, we systemtically search and review the results of randomized controlled clinical trials where ketamine or esketamine were compared to placebo or another control condition. We will analyze if patients who are treated with ketamine/esketamine have lower levels of suicide ideation, suicide attempts, suicides,  and all-cause mortality compared to patients in the control group. "
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    ["first_name"]=>
    string(6) "Joanna"
    ["last_name"]=>
    string(9) "Moncrieff"
    ["degree"]=>
    string(5) "Prof."
    ["primary_affiliation"]=>
    string(25) "University College London"
    ["email"]=>
    string(21) "j.moncrieff@ucl.ac.at"
    ["state_or_province"]=>
    string(6) "London"
    ["country"]=>
    string(14) "United Kingdom"
  }
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      ["p_pers_f_name"]=>
      string(6) "Martin"
      ["p_pers_l_name"]=>
      string(8) "Plöderl"
      ["p_pers_degree"]=>
      string(3) "PhD"
      ["p_pers_pr_affil"]=>
      string(30) "Paracelsus Medical University "
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      ["requires_data_access"]=>
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    ["label"]=>
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  ["property_scientific_abstract"]=>
  string(1204) "Background: Esketamine and ketamine are considered to have rapid and clinically meaningful effects on depression and suicidality and are considered as novel strategies to mitigate suicide risk. Whereas some systematic reviews have been done already, several important new studies were published in the meantime, requiring an updated review. Moreover, reviews often lack a closer look at the timing of the effects and also on important moderators of the effects  (dosing, application, drug-type, self-report vs. clinician assessment).

Objective: to provide and updated systematic review of the effects of esketamine and ketamine on suicidality and moderators of these effects. 

Study design: Systematic review and meta-analysis of randomized clinical trials.

Participants: Patients from randomized clinical esketamine/ketamine trials with any psychiatric disorders.

Primary and secondary outcome measures: primary outcome is suicidal behavior (suicides and suicide attempts) and all cause mortality. Secondary outcome will be suicide ideation based on clinician ratings or patient self-reports. 

Statistical Analysis: random effects meta-analyses and subgroup analysis. "
  ["project_brief_bg"]=>
  string(1061) "Esketamine and ketamine are considered to have rapid and clinically meaningful effects on depression and also suicidality and are considered as novel strategies to mitigate suicide risk [1]. Whereas some systematic reviews have been done already [2,3], several important new studies were published in the meantime, requiring an updated review is lacking. Moreover, reviews often lack a closer look at the timing of the effects, which is important as the efficacy varies with time, at least for single administration of ketamine/esketamine. Moreover, there is a lack of meta-analytic research on potential moderators, such as dosing (single vs. repeated), application (intravenous vs. intranasal), drug-type (esketamine vs. ketamine) etc. Finally, we are not aware of a systematic review which also investigated at suicidal behavior. Thus, a updated systematic review is necessary that also accounts for the characteristics for the interventions and also to provide evidence if esketamine and ketamine have an impact on suicidal ideation/behavior and mortality. "
  ["project_specific_aims"]=>
  string(506) "The aim is to provide an updated systematic review an meta-analysis of the suicide-preventive efficacy (suicide ideation, suicidal behavior, all-cause-mortality) of ketamine and esketamine based on randomized controlled clinical trials. The analysis will account for temporal effects (immediate, short-term, longer-term effects) and also will explore potential moderators of efficacy, such as dosing (single vs. repeated), application (intravenous vs. intranasal), drug-type (esketamine vs. ketamine) etc. "
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    ["label"]=>
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      ["label"]=>
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    }
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      ["label"]=>
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    }
    [2]=>
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      ["value"]=>
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      ["label"]=>
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      ["value"]=>
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      ["label"]=>
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  string(1271) "Inclusion criteria

- RCTs (either double-blind, single-blind) comparing the effect of ketamine or esketamine with placebo or active placebo for the treatment of any primary psychiatric disorder 

- Cross over trial data from the period prior to the cross-over will be included (data from the second period is excluded to protect against the carry -over effect) 

- Trials comparing ketamine or esketamine in combination with an antidepressant, psychotherapy or other intervention will be included as long as other interventions are equally available to those in



Exclusion criteria

Trials where Ketamine was used as an analgesic agent eg. within an ECT or surgical protocol.



Pooling with other studies

We will not pool IPD but instead use aggregated data (means, standard deviations, percentages etc) from the YODA data and from other studies. Thus, we will only use the YODA platform to get the aggregated results for suicide ideation and suicidal behavior for the Esketamine trials. We then use these aggregated data in meta-analysis, together with aggregated non-YODA data



We will base our meta-analysis on summary results (effect size) of each study and not on individual participant data. "
  ["project_main_outcome_measure"]=>
  string(158) "Primary Outcome: suicide attempts, suicides, all-cause-mortality

Secondary Outcome: suicide ideation (based on self-reports and clinician interviews). "
  ["project_main_predictor_indep"]=>
  string(87) "Main Predictor: treatment (esketamine/ketamine vs. placebo or active control). 

"
  ["project_other_variables_interest"]=>
  string(290) "Moderators: time (rapid/short-longer), mode of application (intravenous/nasal etc), drug-type (esketamine/ketamine), dosing (single vs. multiple dosing), primary diagnosis, suicidality as inclusion/exclusion criterion,  active vs. non-active placebo,  assessment (clinician vs. self-report)"
  ["project_stat_analysis_plan"]=>
  string(84) "Random effects meta-analysis, with subgroup analysis to investigate the moderators. "
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      ["value"]=>
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      ["label"]=>
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  ["project_timeline"]=>
  string(72) "Data extraction and analysis: End of 2024. Manuscript draft: Spring 2025"
  ["project_dissemination_plan"]=>
  string(95) "Publication in psychiatric/medical journal and perhaps also in suicide prevention conferences. "
  ["project_bibliography"]=>
  string(816) "
McIntyre RS, Rosenblat JD, Nemeroff CB, et al. Synthesizing the Evidence for Ketamine and Esketamine in Treatment-Resistant Depression: An International Expert Opinion on the Available Evidence and Implementation. Am J Psychiatry. 2021;appiajp202020081251. doi: 10.1176/appi.ajp.2020.20081251
Witt K, Potts J, Hubers A, et al. Ketamine for suicidal ideation in adults with psychiatric disorders: A systematic review and meta-analysis of treatment trials. Aust N Z J Psychiatry. 2020;54:29–45. doi: 10.1177/0004867419883341
Dean RL, Hurducas C, Hawton K, et al. Ketamine and other glutamate receptor modulators for depression in adults with unipolar major depressive disorder. Cochrane Database Syst Rev. 2021;2021. doi: 10.1002/14651858.CD011612.pub3
"
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