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      string(251) "NCT02713282 - A 52-Week, Open-Label, Prospective, Multicenter, International Study of a Transition to the Paliperidone Palmitate 3-Month Formulation In Patients With Schizophrenia Previously Stabilized on the Paliperidone Palmitate 1-Month Formulation"
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  ["project_date_type"]=>
  string(91) "Individual Participant-Level Data, which includes Full CSR and all supporting documentation"
  ["property_scientific_abstract"]=>
  string(1290) "Background: Current epidemiologic literature is limited regarding age of onset of psychosis and duration of untreated psychosis. In particular, information on the variability in the distribution, and impact of any demographic or regional factors are lacking. 

Objective: to estimate the age of onset based on a pooled sample of patients with confirmed schizophrenia from large scale worldwide clinical trials. 

Study design: This is a retrospective pooled analysis of clinical trial data from patients with schizophrenia. In this analysis, we hope to verify the distribution for age of onset of psychosis. Baseline data only will be used, so treatment effect will not be analyzed. 

Participants: Patient level data from 24 clinical trials comprising 11,740 patients will be pooled. 

Main outcome measure: age of onset of schizophrenia (distribution). 

Statistical Analyses: Descriptive statistics and histograms for distribution of average age of onset and duration of untreated psychosis (DUP) will be estimated (mean, median, and 95% CI). Exploratory analyses for differences by potential explanatory factors (gender, substance use and region) will also be performed. Assumptions for normality will be examined (histograms, QQ Plots, Shapiro-Wilk test, etc.)"
  ["project_brief_bg"]=>
  string(3004) "Epidemiological data on the age of onset of psychosis, and duration of untreated psychosis (DUP) are limited (Kessler 2008). To date, most of the estimates from epidemiologic literature are based on individual patient and family interviews. Large scale epidemiologic surveys on mental illness have been performed in the past (Bourdon 1992). But these datasets are limited because participants are mainly North American and estimates from other countries are limited in scope. These surveys have limited generalizability by the fact that they rely on participants to willingly provide information. Due to stigmatization of mental illness, it is possible that estimates obtained by interview are underreported. The validity of the diagnoses obtained from these interviews are also subject to scrutiny because they are based on self-report, or family report. Diagnoses confirmed by a psychiatrist or using standardized criteria (APA 2013) would be preferred. Information on variation by age, sex, or geographic region are also not well characterized.

The age of onset in schizophrenia differs for males and females. Based on past literature, the age of onset for schizophrenia approximates a bimodal distribution for males at 21.4 and 39.2 years old, whereas for females a trimodal distribution is seen at 22.4, 36.6, and 61.5 years old (Castle 1998). The findings of bimodal and trimodal distributions are unusual and could simply be due to chance, skewness of data, improper binning technique or too small of a sample size. It is important to understand if these age distributions for schizophrenia still hold true for both male and female patients. The clinical significance behind this research will help provide quantifiable predictors for when the prevalence of schizophrenia is most common based on the statistical analysis. 

Several large global clinical trial programs in schizophrenia have recently been completed and access to the underlying datasets have been made available to the public through the Yale Open Data Initiative (YODA). These clinical trial datasets each contain information on the demographic information of each patient enrolled in large scale worldwide clinical trials. During trial entry procedures the diagnosis of each patient was verified by a mental health professional according to the Diagnostic and Statistical Manual of mental disorders (DSM) (APA 2013). The demographic information contained within these datasets could be of vital importance to future efforts to understand the origins and typical clinical presentations of patients with newly developed psychosis. Reduction of DUP has positive effects on long-term outcomes, and so any factors to help clinicians understand the natural course of the disease would be important for the scientific community. Similarly, estimation of the average age of onset, with understanding of the low and high ends of distribution would be useful from a clinician?s perspective as part of the differential diagnosis."
  ["project_specific_aims"]=>
  string(1283) "Primary Hypothesis: The average age of onset of schizophrenia is in late teens or early adulthood

Objective: Estimate age of onset of psychosis from a pooled sample of global clinical trial data in patients with diagnosis confirmed schizophrenia

Endpoints: Diagnosis age, Descriptive statistics (n, mean, median, SD, SE) and histograms

Secondary: The average age of onset of schizophrenia varies among geographic region

Objective: Estimate age of onset by geographic region (N America, Latin America, Europe, Asia-Pac)

Endpoints: Diagnosis age. Descriptive statistics (n, mean, median, SD, SE) and histograms along with 95% confidence intervals

Secondary: The average age of onset of schizophrenia varies by sex

Objective: Estimate age of onset by sex (male vs female). Verify whether bimodal or trimodal distributions exist.

Endpoints: Diagnosis age, Descriptive statistics (n, mean, median, SD, SE) and histograms along with 95% confidence intervals

Secondary: Cannabis use is associated with earlier onset of psychosis and longer DUP

Objective: Estimate age of onset by prior cannabis use

Endpoints: Diagnosis age, descriptive statistics (n, mean, median, SD, SE) and histograms along with 95% confidence intervals"
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  ["project_purposes"]=>
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    [0]=>
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      ["value"]=>
      string(32) "Summary-level data meta-analysis"
      ["label"]=>
      string(32) "Summary-level data meta-analysis"
    }
    [1]=>
    array(2) {
      ["value"]=>
      string(66) "Summary-level data meta-analysis using only data from YODA Project"
      ["label"]=>
      string(66) "Summary-level data meta-analysis using only data from YODA Project"
    }
    [2]=>
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      ["value"]=>
      string(36) "Participant-level data meta-analysis"
      ["label"]=>
      string(36) "Participant-level data meta-analysis"
    }
    [3]=>
    array(2) {
      ["value"]=>
      string(66) "Summary-level data meta-analysis using only data from YODA Project"
      ["label"]=>
      string(66) "Summary-level data meta-analysis using only data from YODA Project"
    }
    [4]=>
    array(2) {
      ["value"]=>
      string(37) "Develop or refine statistical methods"
      ["label"]=>
      string(37) "Develop or refine statistical methods"
    }
    [5]=>
    array(2) {
      ["value"]=>
      string(34) "Research on clinical trial methods"
      ["label"]=>
      string(34) "Research on clinical trial methods"
    }
    [6]=>
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      ["value"]=>
      string(28) "Research on comparison group"
      ["label"]=>
      string(28) "Research on comparison group"
    }
  }
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  string(0) ""
  ["project_software_used"]=>
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    string(7) "RStudio"
    ["label"]=>
    string(7) "RStudio"
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  ["project_research_methods"]=>
  string(475) "The data source for this study will be from the aforementioned studies that are posted on YODA. All available YODA studies with schizophrenia patients were reviewed. Studies with adolescent, pediatric, or phase 1 studies were excluded. Only studies with access to patient-level data were included, as we need to pool the samples together for an accurate estimate of the sample distribution. Studies with only access to the clinical study report were excluded for this reason."
  ["project_main_outcome_measure"]=>
  string(1199) "The main outcome measured will be the age of onset for schizophrenia in male and females. The proposed research objectives do not involve any statistical modeling, summary statistics will be provided for each of the primary and secondary endpoints. Variables of interest for the primary and secondary endpoints will be combined. Pooled summary statistics will be generated after combining the patient level datasets together. Duplicate patients will be removed (based on patient identification number). Assumptions underlying normal distribution for each of the continuous variables will be examined graphically. If normality conditions are met, then for continuous variables, histograms and summary statistics (n,mean, median,SD,SE) along with 95% confidence intervals will be presented. No adjustments of alpha for multiple comparisons will be performed. For ordinal or binary variables percentages or proportions within each category (along with a total %) will be calculated and presented. If skewed data are found, these will be presented accordingly in the manuscript and publications as a limitation. Patient level data from the clinical trial datasets will be pooled together using R Studio."
  ["project_main_predictor_indep"]=>
  string(22) "No predictor variables"
  ["project_other_variables_interest"]=>
  string(63) "Other variables of interest: age, sex, substance abuse, region."
  ["project_stat_analysis_plan"]=>
  string(1790) "Since the proposed research objectives do not involve any statistical modeling, summary statistics will be provided for each of the primary and secondary endpoints. Variables of interest for the primary and secondary endpoints will be combined. Pooled summary statistics will be generated after combining the patient level datasets together. Duplicate patients will be removed (based on patient identification number). Assumptions underlying normal distribution for each of the continuous variables will be examined graphically. If normality conditions are met, then for continuous variables, histograms and summary statistics (n, mean, median, SD, SE) along with 95% confidence intervals will be presented. No adjustments of alpha for multiple comparisons will be performed. For ordinal or binary variables percentages or proportions within each category (along with a total %) will be calculated and presented. If skewed data are found, these will be presented accordingly in the manuscript and publications as a limitation.

Patient level data from the clinical trial datasets will be pooled together using R Studio. Due to the nature of the objectives, no formal statistical hypothesis testing or p values will be generated. Since the research objectives are descriptive in nature, no adjustment using propensity score matching is needed; other more advanced modeling methods (logistic regression, multivariable regression, non-linear methods, non-parametric) are not necessary.

Information regarding patient identifying variables will not be examined including: name, initials, zip code, address, primary treating physician or other factors. The anonymized patient identification number from the clinical trial will be used to pool patients together and to avoid duplicates."
  ["project_timeline"]=>
  string(695) "Apr 16, 2021: Start Date -- Gather authors, agree upon analysis plan, present plan to YODA

Apr 30, 2021: Start Analysis -- Obtain datasets from YODA, perform analyses

May 28, 2021: Complete Analyses -- Perform statistical analyses, quality control check

June 30, 2021: Draft manuscript and posters -- Draft manuscript and posters. Submit abstracts to conferences

July 30, 2021: Submit manuscript -- Submit manuscript to first journal choice

Aug 30, 2021	Revise/resubmit	Revise manuscript based on reviewers? comments and/or submit to second choice journal

Dec 30, 2021	Results reported back to YODA	Results of primary manuscript and abstracts reported to YODA"
  ["project_dissemination_plan"]=>
  string(373) "Submission as Abstract/Poster: US Psych Congress Oct 2021; American Psychiatric Association Annual Meeting 2022; Society for Biological Psychiatry Annual Meeting; Schizophrenia International Research Society 2022

Publication: Peer reviewed journal options include: Neuropsychiatric Disease & Treatment, Schizophrenia Bulletin, Journal of Psychopharmacology, CNS Drugs"
  ["project_bibliography"]=>
  string(10187) "
1.	Kessler, R. C., Amminger, G. P., Aguilar-Gaxiola, S., Alonso, J., Lee, S., & Ustn, T. B. (2007). Age of onset of mental disorders: a review of recent literature. Current opinion in psychiatry, 20(4), 359?364. https://doi.org/10.1097/YCO.0b013e32816ebc8c

2.	Bourdon, K. H., Rae, D. S., Locke, B. Z., Narrow, W. E., & Regier, D. A. (1992). Estimating the prevalence of mental disorders in U.S. adults from the Epidemiologic Catchment Area Survey. Public health reports (Washington, D.C. : 1974), 107(6), 663?668.

3.	American Psychiatric Association. (2013). Cautionary statement for forensic use of DSM-5. In Diagnostic and statistical manual of mental disorders (5th ed.). doi:10.1176/appi.books.9780890425596.744053

4.	Castle, D., Sham, P., & Murray, R. (1998). Differences in distribution of ages of onset in males and females with schizophrenia. Schizophrenia research, 33(3), 179?183. https://doi.org/10.1016/s0920-9964(98)00070

5.	Davidson, M., Emsley, R., Kramer, M., Ford, L., Pan, G., Lim, P., & Eerdekens, M. (2007). Efficacy, safety and early response of paliperidone extended-release tablets (paliperidone ER): results of a 6-week, randomized, placebo-controlled study. Schizophrenia research, 93(1-3), 117?130. https://doi.org/10.1016/j.schres.2007.03.003

6.	Tzimos, A., Samokhvalov, V., Kramer, M., Ford, L., Gassmann-Mayer, C., Lim, P., & Eerdekens, M. (2008). Safety and tolerability of oral paliperidone extended-release tablets in elderly patients with schizophrenia: a double-blind, placebo-controlled study with six-month open-label extension. The American journal of geriatric psychiatry : official journal of the American Association for Geriatric Psychiatry, 16(1), 31?43. https://doi.org/10.1097/JGP.0b013e31815a3e7a

7.	Kramer, M., Simpson, G., Maciulis, V., Kushner, S., Vijapurkar, U., Lim, P., & Eerdekens, M. (2007). Paliperidone extended-release tablets for prevention of symptom recurrence in patients with schizophrenia: a randomized, double-blind, placebo-controlled study. Journal of clinical psychopharmacology, 27(1), 6?14. https://doi.org/10.1097/JCP.0b013e31802dda4a

8.	Canuso, C. M., Dirks, B., Carothers, J., Kosik-Gonzalez, C., Bossie, C. A., Zhu, Y., Damaraju, C. V., Kalali, A. H., & Mahmoud, R. (2009). Randomized, double-blind, placebo-controlled study of paliperidone extended-release and quetiapine in inpatients with recently exacerbated schizophrenia. The American journal of psychiatry, 166(6), 691?701. https://doi.org/10.1176/appi.ajp.2009.08040613

9.	Schreiner, A., Lahaye, M., Peuskens, J., Naber, D., Dilbaz, N., Millet, B., Franco, M. A., Rancans, E., Turczynski, J., Smeraldi, E., Lara, E., & Neznanov, N. G. (2014). Paliperidone extended-release in patients with non-acute schizophrenia previously unsuccessfully treated with other oral antipsychotics. Expert opinion on pharmacotherapy, 15(5), 593?603. https://doi.org/10.1517/14656566.2014.884071

10.	Coppola, D., Melkote, R., Lannie, C., Singh, J., Nuamah, I., Gopal, S., Hough, D., & Palumbo, J. (2011). Efficacy and Safety of Paliperidone Extended Release 1.5 mg/day-A Double-blind, Placebo- and Active-Controlled, Study in the Treatment of Patients with Schizophrenia. Psychopharmacology bulletin, 44(2), 54?72.

11.	Rui, Q., Wang, Y., Liang, S., Liu, Y., Wu, Y., Wu, Q., Nuamah, I., & Gopal, S. (2014). Relapse prevention study of paliperidone extended-release tablets in Chinese patients with schizophrenia. Progress in neuro-psychopharmacology & biological psychiatry, 53, 45?53. https://doi.org/10.1016/j.pnpbp.2014.02.007

12.	Kramer, M., Litman, R., Hough, D., Lane, R., Lim, P., Liu, Y., & Eerdekens, M. (2010). Paliperidone palmitate, a potential long-acting treatment for patients with schizophrenia. Results of a randomized, double-blind, placebo-controlled efficacy and safety study. The international journal of neuropsychopharmacology, 13(5), 635?647. https://doi.org/10.1017/S1461145709990988

13.	Nasrallah, H. A., Gopal, S., Gassmann-Mayer, C., Quiroz, J. A., Lim, P., Eerdekens, M., Yuen, E., & Hough, D. (2010). A controlled, evidence-based trial of paliperidone palmitate, a long-acting injectable antipsychotic, in schizophrenia. Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology, 35(10), 2072?2082. https://doi.org/10.1038/npp.2010.7

14.	Hough, D., Gopal, S., Vijapurkar, U., Lim, P., Morozova, M., & Eerdekens, M. (2010). Paliperidone palmitate maintenance treatment in delaying the time-to-relapse in patients with schizophrenia: a randomized, double-blind, placebo-controlled study. Schizophrenia research, 116(2-3), 107?117. https://doi.org/10.1016/j.schres.2009.10.026

15.	Hough, D., Lindenmayer, J. P., Gopal, S., Melkote, R., Lim, P., Herben, V., Yuen, E., & Eerdekens, M. (2009). Safety and tolerability of deltoid and gluteal injections of paliperidone palmitate in schizophrenia. Progress in neuro-psychopharmacology & biological psychiatry, 33(6), 1022?1031. https://doi.org/10.1016/j.pnpbp.2009.05.014

16.	Hough, D., Lindenmayer, J. P., Gopal, S., Melkote, R., Lim, P., Herben, V., Yuen, E., & Eerdekens, M. (2009). Safety and tolerability of deltoid and gluteal injections of paliperidone palmitate in schizophrenia. Progress in neuro-psychopharmacology & biological psychiatry, 33(6), 1022?1031. https://doi.org/10.1016/j.pnpbp.2009.05.014

17.	Gopal, S., Hough, D. W., Xu, H., Lull, J. M., Gassmann-Mayer, C., Remmerie, B. M., Eerdekens, M. H., & Brown, D. W. (2010). Efficacy and safety of paliperidone palmitate in adult patients with acutely symptomatic schizophrenia: a randomized, double-blind, placebo-controlled, dose-response study. International clinical psychopharmacology, 25(5), 247?256. https://doi.org/10.1097/YIC.0b013e32833948fa

18.	Fleischhacker, W. W., Gopal, S., Lane, R., Gassmann-Mayer, C., Lim, P., Hough, D., Remmerie, B., & Eerdekens, M. (2012). A randomized trial of paliperidone palmitate and risperidone long-acting injectable in schizophrenia. The international journal of neuropsychopharmacology, 15(1), 107?118. https://doi.org/10.1017/S1461145711001076

19.	Pandina, G., Lane, R., Gopal, S., Gassmann-Mayer, C., Hough, D., Remmerie, B., & Simpson, G. (2011). A double-blind study of paliperidone palmitate and risperidone long-acting injectable in adults with schizophrenia. Progress in neuro-psychopharmacology & biological psychiatry, 35(1), 218?226. https://doi.org/10.1016/j.pnpbp.2010.11.008

20.	Pandina, G. J., Lindenmayer, J. P., Lull, J., Lim, P., Gopal, S., Herben, V., Kusumakar, V., Yuen, E., & Palumbo, J. (2010). A randomized, placebo-controlled study to assess the efficacy and safety of 3 doses of paliperidone palmitate in adults with acutely exacerbated schizophrenia. Journal of clinical psychopharmacology, 30(3), 235?244. https://doi.org/10.1097/JCP.0b013e3181dd3103

21.	Li, H., Rui, Q., Ning, X., Xu, H., & Gu, N. (2011). A comparative study of paliperidone palmitate and risperidone long-acting injectable therapy in schizophrenia. Progress in neuro-psychopharmacology & biological psychiatry, 35(4), 1002?1008. https://doi.org/10.1016/j.pnpbp.2011.02.001

22.	Schreiner, A., Adamsoo, K., Altamura, AC., Franco, M., Gorwood, P., Nezanov, NG., Schronen, J., Ucok, A., Zink, M., Janik, A., Cherubin, P., Lahaye, M., & Hargarter, L. (2015). Paliperidone palmitate versus oral antipsychotics in recently diagnosed schizophrenia. Schizophrenia Research, 169(1-3), 393-399.

23.	Takahashi, N., Takahashi, M., Saito, T., Izumi, M., Imai, Y., Saito, Y., Shimizu, H., & Matsumura, T. (2013). A Long-Term, Open ? Label Study of Paliperidone Palmitate in Patients with Schizophrenia. J-Global, 33(11), 2393-2412.

24.	Zhang F, Si T, Chiou CF, Harris AW, Kim CY, Jahagirdar P, Ascher S. Efficacy, safety, and impact on hospitalizations of paliperidone palmitate in recent-onset schizophrenia. Neuropsychiatr Dis Treat. 2015 Mar 11;11:657-68. doi: 10.2147/NDT.S77778. PMID: 25792835; PMCID: PMC4362974.

25.	Schreiner, A., Bergmans, P., Cherubin, P., Keim, S., Rancans, E., Bez, Y., Parellada, E., Carpiniello, B., Vidailhet, P., & Hargarter, L. (2014). A prospective flexible-dose study of paliperidone palmitate in nonacute but symptomatic patients with schizophrenia previously unsuccessfully treated with oral antipsychotic agents. Clinical therapeutics, 36(10), 1372?88.e1. https://doi.org/10.1016/j.clinthera.2014.08.014

26.	Wakamatsu, A., Takahashi, N., Takahashi, M., Saito, T., Izumi, M., Saito, Y., Shimizu, H., & Matsumara, T. (2013). Evaluation of Efficacy and Safety of Paliperidone with Schizophrenia: Subpopulation Analysis of Japanese Patients in the 13-Week, Double-Blind, Randomized, Placebo-Controlled Asian Study. J-Global, 33(11), 2377-2392.

27.	Savitz, A. J., Xu, H., Gopal, S., Nuamah, I., Ravenstijn, P., Janik, A., Schotte, A., Hough, D., & Fleischhacker, W. W. (2016). Efficacy and Safety of Paliperidone Palmitate 3-Month Formulation for Patients with Schizophrenia: A Randomized, Multicenter, Double-Blind, Noninferiority Study. The international journal of neuropsychopharmacology, 19(7), pyw018. https://doi.org/10.1093/ijnp/pyw018

28.	Berwaerts, J., Liu, Y., Gopal, S., Nuamah, I., Xu, H., Savitz, A., Coppola, D., Schotte, A., Remmerie, B., Maruta, N., & Hough, D. W. (2015). Efficacy and Safety of the 3-Month Formulation of Paliperidone Palmitate vs Placebo for Relapse Prevention of Schizophrenia: A Randomized Clinical Trial. JAMA psychiatry, 72(8), 830?839. https://doi.org/10.1001/jamapsychiatry.2015.0241

29.	Pungor, K., Bozikas, V. P., Emsley, R., Llorca, P.-M., Gopal, S., Mathews, M., Wooller, A., & Bergmans, P. (2020). Stable patients with schizophrenia switched to paliperidone palmitate 3-monthly formulation in a naturalistic setting: impact of patient age and disease duration on outcomes. Therapeutic Advances in Psychopharmacology. https://doi.org/10.1177/2045125320981500
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data partner
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pi country
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}


pi affil
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}


products
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}


num of trials
array(1) {
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}


res
array(1) {
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}