메뉴 건너뛰기




Volumn 91, Issue 5, 2012, Pages 863-871

Joint modeling of efficacy, dropout, and tolerability in flexible-dose trials: A case study in depression

Author keywords

[No Author keywords available]

Indexed keywords

ANTIDEPRESSANT AGENT;

EID: 84859983690     PISSN: 00099236     EISSN: 15326535     Source Type: Journal    
DOI: 10.1038/clpt.2011.322     Document Type: Article
Times cited : (9)

References (26)
  • 2
    • 49149092360 scopus 로고    scopus 로고
    • Sensitivity of the individual items of the Hamilton depression rating scale to response and its consequences for the assessment of efficacy
    • Santen, G., Gomeni, R., Danhof, M. & Della Pasqua, O. Sensitivity of the individual items of the Hamilton depression rating scale to response and its consequences for the assessment of efficacy. J. Psychiatr. Res. 42, 1000-1009 (2008).
    • (2008) J. Psychiatr. Res. , vol.42 , pp. 1000-1009
    • Santen, G.1    Gomeni, R.2    Danhof, M.3    Della Pasqua, O.4
  • 3
    • 84859938128 scopus 로고    scopus 로고
    • Modeling placebo response in depression using a mechanistic longitudinal model approach
    • Abstract 818
    • Cosson, V. & Gomeni, R. Modeling placebo response in depression using a mechanistic longitudinal model approach. Population Approach Group in Europe (PAGE) 14th Meeting, Abstract 818. 〈http://www.page-meeting.org/?abstract= 818〉 (2005).
    • (2005) Population Approach Group in Europe (PAGE) 14th Meeting
    • Cosson, V.1    Gomeni, R.2
  • 4
    • 34250675992 scopus 로고    scopus 로고
    • Using disease progression models as a tool to detect drug effect
    • Mould, D.R., Denman, N.G. & Duffull, S. Using disease progression models as a tool to detect drug effect. Clin. Pharmacol. Ther. 82, 81-86 (2007).
    • (2007) Clin. Pharmacol. Ther. , vol.82 , pp. 81-86
    • Mould, D.R.1    Denman, N.G.2    Duffull, S.3
  • 5
    • 58049191296 scopus 로고    scopus 로고
    • Modeling placebo response in depression trials using a longitudinal model with informative dropout
    • Gomeni, R., Lavergne, A. & Merlo-Pich, E. Modeling placebo response in depression trials using a longitudinal model with informative dropout. Eur. J. Pharm. Sci. 36, 4-10 (2009).
    • (2009) Eur. J. Pharm. Sci. , vol.36 , pp. 4-10
    • Gomeni, R.1    Lavergne, A.2    Merlo-Pich, E.3
  • 6
    • 61449255220 scopus 로고    scopus 로고
    • Evaluation of structural models to describe the effect of placebo upon the time course of major depressive disorder
    • Shang, E.Y. et al. Evaluation of structural models to describe the effect of placebo upon the time course of major depressive disorder. J. Pharmacokinet. Pharmacodyn. 36, 63-80 (2009).
    • (2009) J. Pharmacokinet. Pharmacodyn. , vol.36 , pp. 63-80
    • Shang, E.Y.1
  • 8
    • 49949094420 scopus 로고    scopus 로고
    • Model-based approach and signal detection theory to evaluate the performance of recruitment centers in clinical trials with antidepressant drugs
    • Merlo-Pich, E. & Gomeni, R. Model-based approach and signal detection theory to evaluate the performance of recruitment centers in clinical trials with antidepressant drugs. Clin. Pharmacol. Ther. 84, 378-384 (2008).
    • (2008) Clin. Pharmacol. Ther. , vol.84 , pp. 378-384
    • Merlo-Pich, E.1    Gomeni, R.2
  • 9
    • 34247325672 scopus 로고    scopus 로고
    • Bayesian modeling and ROC analysis to predict placebo responders using clinical score measured in the initial weeks of treatment in depression trials
    • Gomeni, R. & Merlo-Pich, E. Bayesian modeling and ROC analysis to predict placebo responders using clinical score measured in the initial weeks of treatment in depression trials. Br. J. Clin. Pharmacol. 63, 595-613 (2007).
    • (2007) Br. J. Clin. Pharmacol. , vol.63 , pp. 595-613
    • Gomeni, R.1    Merlo-Pich, E.2
  • 10
    • 68149157300 scopus 로고    scopus 로고
    • Model-based approaches to increase efficiency of drug development in schizophrenia: A can't miss opportunity
    • Nucci, G., Gomeni, R. & Poggesi, I. Model-based approaches to increase efficiency of drug development in schizophrenia: a can't miss opportunity. Expert Opin. Drug Discov. 4, 837-856 (2009).
    • (2009) Expert Opin. Drug Discov. , vol.4 , pp. 837-856
    • Nucci, G.1    Gomeni, R.2    Poggesi, I.3
  • 11
    • 52149120282 scopus 로고    scopus 로고
    • Evaluation of treatment response in depression studies using a Bayesian parametric cure rate model
    • Santen, G., Danhof, M. & Della Pasqua, O. Evaluation of treatment response in depression studies using a Bayesian parametric cure rate model. J. Psychiatr. Res. 42, 1189-1197 (2008).
    • (2008) J. Psychiatr. Res. , vol.42 , pp. 1189-1197
    • Santen, G.1    Danhof, M.2    Della Pasqua, O.3
  • 12
    • 84859938127 scopus 로고    scopus 로고
    • Population Disease Progress Models for the Time Course of HAMD Score in Depressed Patients Receiving Placebo in Anti-Depressant Clinical Trials
    • Abstract 311
    • Holford, N., Li, J., Benincosa, L. & Birath, M. Population Disease Progress Models for the Time Course of HAMD Score in Depressed Patients Receiving Placebo in Anti-Depressant Clinical Trials. Population Approach Group in Europe (PAGE) 11th Meeting, Abstract 311. 〈http://www.page-meeting.org/? abstract=311〉 (2002).
    • (2002) Population Approach Group in Europe (PAGE) 11th Meeting
    • Holford, N.1    Li, J.2    Benincosa, L.3    Birath, M.4
  • 13
    • 0004235298 scopus 로고
    • 4th edn, Text Revision
    • A merican Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders. 4th edn, Text Revision. 〈http://psych.org/MainMenu/ Research/DSMIV.aspx〉 (1994).
    • (1994) Diagnostic and Statistical Manual of Mental Disorders
  • 14
    • 0038014050 scopus 로고    scopus 로고
    • Frequency of positive studies among fixed and flexible dose antidepressant clinical trials: An analysis of the food and drug administration summary basis of approval reports
    • Khan, A., Khan, S.R., Walens, G., Kolts, R. & Giller, E.L. Frequency of positive studies among fixed and flexible dose antidepressant clinical trials: an analysis of the food and drug administration summary basis of approval reports. Neuropsychopharmacology 28, 552-557 (2003).
    • (2003) Neuropsychopharmacology , vol.28 , pp. 552-557
    • Khan, A.1    Khan, S.R.2    Walens, G.3    Kolts, R.4    Giller, E.L.5
  • 15
    • 0038402581 scopus 로고    scopus 로고
    • A joint model for nonlinear longitudinal data with informative dropout
    • Hu, C. & Sale, M.E. A joint model for nonlinear longitudinal data with informative dropout. J. Pharmacokinet. Pharmacodyn. 30, 83-103 (2003).
    • (2003) J. Pharmacokinet. Pharmacodyn. , vol.30 , pp. 83-103
    • Hu, C.1    Sale, M.E.2
  • 16
    • 79956001386 scopus 로고    scopus 로고
    • Informative dropout modeling of longitudinal ordered categorical data and model validation: Application to exposure-response modeling of physician's global assessment score for ustekinumab in patients with psoriasis
    • Hu, C., Szapary, P.O., Yeilding, N. & Zhou, H. Informative dropout modeling of longitudinal ordered categorical data and model validation: application to exposure-response modeling of physician's global assessment score for ustekinumab in patients with psoriasis. J. Pharmacokinet. Pharmacodyn. 38, 237-260 (2011).
    • (2011) J. Pharmacokinet. Pharmacodyn. , vol.38 , pp. 237-260
    • Hu, C.1    Szapary, P.O.2    Yeilding, N.3    Zhou, H.4
  • 17
    • 10644222277 scopus 로고    scopus 로고
    • Analyzing incomplete longitudinal clinical trial data
    • Molenberghs, G. et al. Analyzing incomplete longitudinal clinical trial data. Biostatistics 5, 445-464 (2004).
    • (2004) Biostatistics , vol.5 , pp. 445-464
    • Molenberghs, G.1
  • 19
    • 77149134951 scopus 로고    scopus 로고
    • Proof of concept: A PhRMA position paper with recommendations for best practice
    • Cartwright, M.E. et al. Proof of concept: a PhRMA position paper with recommendations for best practice. Clin. Pharmacol. Ther. 87, 278-285 (2010).
    • (2010) Clin. Pharmacol. Ther. , vol.87 , pp. 278-285
    • Cartwright, M.E.1
  • 20
    • 0006407254 scopus 로고    scopus 로고
    • WinBUGS - A Bayesian modeling framework: Concepts, structure and extensibility
    • Lunn, D.J., Thomas, A., Best, N. & Spiegelhalter, D. WinBUGS - A Bayesian modeling framework: concepts, structure and extensibility. Stat. Comput. 10, 325-337 (2000).
    • (2000) Stat. Comput. , vol.10 , pp. 325-337
    • Lunn, D.J.1    Thomas, A.2    Best, N.3    Spiegelhalter, D.4
  • 22
    • 72349097560 scopus 로고    scopus 로고
    • Joint modeling of dizziness, drowsiness, and dropout associated with pregabalin and placebo treatment of generalized anxiety disorder
    • Frame, B., Miller, R. & Hutmacher, M.M. Joint modeling of dizziness, drowsiness, and dropout associated with pregabalin and placebo treatment of generalized anxiety disorder. J. Pharmacokinet. Pharmacodyn. 36, 565-584 (2009).
    • (2009) J. Pharmacokinet. Pharmacodyn. , vol.36 , pp. 565-584
    • Frame, B.1    Miller, R.2    Hutmacher, M.M.3
  • 23
    • 79955537100 scopus 로고    scopus 로고
    • Modeling dropout from adverse event data: Impact of dosing regimens across pregabalin trials in the treatment of generalized anxiety disorder
    • Lalovic, B., Hutmacher, M., Frame, B. & Miller, R. Modeling dropout from adverse event data: impact of dosing regimens across pregabalin trials in the treatment of generalized anxiety disorder. J. Clin. Pharmacol. 51, 706-718 (2011).
    • (2011) J. Clin. Pharmacol. , vol.51 , pp. 706-718
    • Lalovic, B.1    Hutmacher, M.2    Frame, B.3    Miller, R.4
  • 24
    • 70349972975 scopus 로고    scopus 로고
    • Differences in adverse effect reporting in placebo groups in SSRI and tricyclic antidepressant trials: A systematic review and meta-analysis
    • Rief, W. et al. Differences in adverse effect reporting in placebo groups in SSRI and tricyclic antidepressant trials: a systematic review and meta-analysis. Drug Saf. 32, 1041-1056 (2009).
    • (2009) Drug Saf. , vol.32 , pp. 1041-1056
    • Rief, W.1
  • 25
    • 9144261617 scopus 로고    scopus 로고
    • The Inventory of Depressive Symptomatology, Clinician Rating (IDS-C) and Self-Report (IDS-SR), and the Quick Inventory of Depressive Symptomatology, Clinician Rating (QIDS-C) and Self-Report (QIDS-SR) in public sector patients with mood disorders: A psychometric evaluation
    • Trivedi, M.H. et al. The Inventory of Depressive Symptomatology, Clinician Rating (IDS-C) and Self-Report (IDS-SR), and the Quick Inventory of Depressive Symptomatology, Clinician Rating (QIDS-C) and Self-Report (QIDS-SR) in public sector patients with mood disorders: a psychometric evaluation. Psychol. Med. 34, 73-82 (2004).
    • (2004) Psychol. Med. , vol.34 , pp. 73-82
    • Trivedi, M.H.1
  • 26
    • 70149113077 scopus 로고    scopus 로고
    • R Foundation for Statistical Computing, Vienna, Austria
    • R Development Core Team. R: A Language and Environment for Statistical Computing. (R Foundation for Statistical Computing, Vienna, Austria). 〈http://www.R-project.org〉 2009.
    • (2009) R: A Language and Environment for Statistical Computing


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.