C H Mallinckrodt

Summary

Affiliation: Eli Lilly and Company
Country: USA

Publications

  1. ncbi Assessing and interpreting treatment effects in longitudinal clinical trials with missing data
    Craig H Mallinckrodt
    Eli Lilly and Company, Lilly Corporate Center, Indianapolis, Indiana 46285, USA
    Biol Psychiatry 53:754-60. 2003
  2. ncbi Duloxetine 60 mg once-daily in the treatment of painful physical symptoms in patients with major depressive disorder
    Stephen K Brannan
    Cyberonics, Houston, TX 77058, USA
    J Psychiatr Res 39:43-53. 2005
  3. pmc Duloxetine in the treatment of major depressive disorder: comparisons of safety and efficacy
    Rahn K Bailey
    National Medical Association, League City, TX, USA
    J Natl Med Assoc 98:437-47. 2006
  4. ncbi Duloxetine versus escitalopram and placebo in the treatment of patients with major depressive disorder: onset of antidepressant action, a non-inferiority study
    Andrew A Nierenberg
    Depression Clinical and Research Program, Massachusetts General Hospital, Boston, MA, USA
    Curr Med Res Opin 23:401-16. 2007
  5. ncbi Signal detection and placebo response in schizophrenia: parallels with depression
    Craig H Mallinckrodt
    Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN, USA
    Psychopharmacol Bull 43:53-72. 2010
  6. doi A structured approach to choosing estimands and estimators in longitudinal clinical trials
    C H Mallinckrodt
    Eli Lilly and Co, Lilly Corporate Center, Indianapolis, IN 46285, USA
    Pharm Stat 11:456-61. 2012
  7. doi A structured framework for assessing sensitivity to missing data assumptions in longitudinal clinical trials
    C H Mallinckrodt
    Eli Lilly and Co, Lilly Corporate Center, Indianapolis, IN, USA
    Pharm Stat 12:1-6. 2013
  8. doi A portfolio-based approach to optimize proof-of-concept clinical trials
    Craig Mallinckrodt
    Eli Lilly and Company, Indianapolis, IN 46285, USA
    J Biopharm Stat 22:596-607. 2012
  9. pmc Evaluating dose response from flexible dose clinical trials
    Ilya Lipkovich
    Lilly Research Laboratories, Eli Lilly and Company, Indianapolis Indiana, USA
    BMC Psychiatry 8:3. 2008
  10. ncbi Differential antidepressant symptom efficacy: placebo-controlled comparisons of duloxetine and SSRIs (fluoxetine, paroxetine, escitalopram)
    Craig H Mallinckrodt
    Lilly Research Laboratories, Indianapolis, Ind 46285, USA
    Neuropsychobiology 56:73-85. 2007

Detail Information

Publications47

  1. ncbi Assessing and interpreting treatment effects in longitudinal clinical trials with missing data
    Craig H Mallinckrodt
    Eli Lilly and Company, Lilly Corporate Center, Indianapolis, Indiana 46285, USA
    Biol Psychiatry 53:754-60. 2003
    ..We illustrate how repeated-measures analyses can be used to enhance decision-making, and we review the caveats that remain regarding the use of LOCF as a composite measure...
  2. ncbi Duloxetine 60 mg once-daily in the treatment of painful physical symptoms in patients with major depressive disorder
    Stephen K Brannan
    Cyberonics, Houston, TX 77058, USA
    J Psychiatr Res 39:43-53. 2005
    ..The efficacy of duloxetine, a balanced and potent dual reuptake inhibitor of 5-HT and NE, was evaluated within a cohort of depressed patients with associated painful physical symptoms...
  3. pmc Duloxetine in the treatment of major depressive disorder: comparisons of safety and efficacy
    Rahn K Bailey
    National Medical Association, League City, TX, USA
    J Natl Med Assoc 98:437-47. 2006
    ..Pooled data from double-blind, placebo-controlled studies were utilized to compare the safety and efficacy of duloxetine in the treatment of major depressive disorder (MDD) in African-American and Caucasian patients...
  4. ncbi Duloxetine versus escitalopram and placebo in the treatment of patients with major depressive disorder: onset of antidepressant action, a non-inferiority study
    Andrew A Nierenberg
    Depression Clinical and Research Program, Massachusetts General Hospital, Boston, MA, USA
    Curr Med Res Opin 23:401-16. 2007
    ..The purpose of this non-inferiority study was to compare the speed of onset of antidepressant efficacy for duloxetine (a dual serotonin and norepinephrine reuptake inhibitor) and escitalopram (a selective serotonin reuptake inhibitor)...
  5. ncbi Signal detection and placebo response in schizophrenia: parallels with depression
    Craig H Mallinckrodt
    Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN, USA
    Psychopharmacol Bull 43:53-72. 2010
    ..These limitations prevent definitive conclusions. However, results are consistent with previous findings in depression where having a higher percent of patients randomized to placebo increased drug-placebo differences...
  6. doi A structured approach to choosing estimands and estimators in longitudinal clinical trials
    C H Mallinckrodt
    Eli Lilly and Co, Lilly Corporate Center, Indianapolis, IN 46285, USA
    Pharm Stat 11:456-61. 2012
    ..Controlled imputation approaches, such as placebo multiple imputation, can be a flexible and transparent framework for formulating primary analyses of effectiveness estimands and sensitivity analyses for efficacy estimands...
  7. doi A structured framework for assessing sensitivity to missing data assumptions in longitudinal clinical trials
    C H Mallinckrodt
    Eli Lilly and Co, Lilly Corporate Center, Indianapolis, IN, USA
    Pharm Stat 12:1-6. 2013
    ....
  8. doi A portfolio-based approach to optimize proof-of-concept clinical trials
    Craig Mallinckrodt
    Eli Lilly and Company, Indianapolis, IN 46285, USA
    J Biopharm Stat 22:596-607. 2012
    ..However, the present work also highlighted the need to consider cost structure using realistic input parameters relevant to the question of interest...
  9. pmc Evaluating dose response from flexible dose clinical trials
    Ilya Lipkovich
    Lilly Research Laboratories, Eli Lilly and Company, Indianapolis Indiana, USA
    BMC Psychiatry 8:3. 2008
    ..The true dose effect in flexible-dose clinical trials may be obscured and even reversed because dose and outcome are related...
  10. ncbi Differential antidepressant symptom efficacy: placebo-controlled comparisons of duloxetine and SSRIs (fluoxetine, paroxetine, escitalopram)
    Craig H Mallinckrodt
    Lilly Research Laboratories, Indianapolis, Ind 46285, USA
    Neuropsychobiology 56:73-85. 2007
    ....
  11. ncbi Duloxetine for the treatment of major depressive disorder: a closer look at efficacy and safety data across the approved dose range
    Craig H Mallinckrodt
    Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN 46285, USA
    J Psychiatr Res 40:337-48. 2006
    ..This analysis focuses on efficacy and safety data obtained from studies of duloxetine for the treatment of major depressive disorder (MDD) within the approved dose range of 40-60 mg/day...
  12. pmc Duloxetine in the treatment of Major Depressive Disorder: a comparison of efficacy in patients with and without melancholic features
    Craig H Mallinckrodt
    Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN 46285, USA
    BMC Psychiatry 5:1. 2005
    ..Pooled data from double-blind, placebo-controlled studies were utilized to compare the efficacy of duloxetine in depressed patients with and without melancholic features...
  13. ncbi The effect of correlation structure on treatment contrasts estimated from incomplete clinical trial data with likelihood-based repeated measures compared with last observation carried forward ANOVA
    Craig H Mallinckrodt
    Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN 46285, USA
    Clin Trials 1:477-89. 2004
    ....
  14. ncbi Simple options for improving signal detection in antidepressant clinical trials
    Craig H Mallinckrodt
    Eli Lilly and Company, Lilly Corporate Center, Indianapolis, Indiana, USA
    Psychopharmacol Bull 40:101-14. 2007
    ..Researchers may be able to take advantage of these easy-to-implement methods while we wait for further improvements in other areas...
  15. doi The enrichment window approach as a means of dealing with placebo response in antidepressant clinical trials
    C H Mallinckrodt
    Lilly Research Labs, Indianapolis, Indiana, USA
    Clin Pharmacol Ther 88:592-4. 2010
    ..The method appears to increase the signal in situations in which the test drug is better than placebo. However, confirmation of its impact on the rate of false-positive results is needed before the method can be used prospectively...
  16. ncbi The test of public scrutiny
    Craig H Mallinckrodt
    Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN 46285, USA
    Pharm Stat 5:249-52. 2006
  17. pmc The efficacy of duloxetine: a comprehensive summary of results from MMRM and LOCF_ANCOVA in eight clinical trials
    Craig H Mallinckrodt
    Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, USA
    BMC Psychiatry 4:26. 2004
    ..We compared results from MMRM and LOCF_ANCOVA analyses across eight clinical trials of duloxetine in order to investigate how the choice of primary analysis may influence interpretations of efficacy...
  18. ncbi A case study comparing a randomized withdrawal trial and a double-blind long-term trial for assessing the long-term efficacy of an antidepressant
    Craig Mallinckrodt
    Eli Lilly and Company, Indianapolis, IN 46285, USA
    Pharm Stat 6:9-22. 2007
    ..Our case study suggests that the DBLE design can provide definitive answers to important questions and may be a useful design for assessing long-term treatment effects...
  19. ncbi Recent developments in improving signal detection and reducing placebo response in psychiatric clinical trials
    Craig H Mallinckrodt
    Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN 46285, USA
    J Psychiatr Res 45:1202-7. 2011
    ..Utilizing appropriate analytic techniques and randomizing an adequate fraction of patients to placebo are perhaps the most broadly applicable approaches...
  20. pmc The impact of analytic method on interpretation of outcomes in longitudinal clinical trials
    A Prakash
    Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN 46285, USA
    Int J Clin Pract 62:1147-58. 2008
    ..In this investigation, we compare results from MMRM, LOCF and OC in order to illustrate the potential biases and problems in interpretation...
  21. ncbi Accounting for dropout bias using mixed-effects models
    C H Mallinckrodt
    Eli Lilly and Co, Lilly Corporate Center, Indianapolis, Indiana 46285, USA
    J Biopharm Stat 11:9-21. 2001
    ..Standard errors and confidence intervals from MMRM accurately reflected the uncertainty of the estimates, whereas standard errors and confidence intervals from LOCF underestimated uncertainty...
  22. ncbi Duloxetine in the treatment of major depressive disorder: a placebo- and paroxetine-controlled trial
    D G S Perahia
    Lilly Research Center, Erl Wood, Sunninghill Road, Windlesham, Surrey GU20 6PH, UK
    Eur Psychiatry 21:367-78. 2006
    ..Duloxetine doses of 80 and 120 mg/day were assessed for efficacy and safety in the treatment of major depressive disorder (MDD)...
  23. ncbi Duloxetine in the treatment of major depressive disorder: a double-blind clinical trial
    David J Goldstein
    Eli Lilly and Company, and Department of Pharmacology and Toxicology, Indiana University Medical School, Indianapolis 46285, USA
    J Clin Psychiatry 63:225-31. 2002
    ..Duloxetine hydrochloride, a dual reuptake inhibitor of serotonin and norepinephrine, was evaluated for therapeutic efficacy and safety/tolerability in the treatment of major depression...
  24. ncbi A local influence sensitivity analysis for incomplete longitudinal depression data
    Shuyi Shen
    Eli Lilly and Company, Indianapolis, Indiana, USA
    J Biopharm Stat 16:365-84. 2006
    ..In this article, we apply the local influence sensitivity tool (Verbeke et al., 2001) to a longitudinal depression trial, thereby applying it to continuous outcomes from clinical trials...
  25. ncbi Duloxetine in the treatment of depression: a double-blind placebo-controlled comparison with paroxetine
    David J Goldstein
    PRN Consulting, Indianapolis, IN, USA
    J Clin Psychopharmacol 24:389-99. 2004
    ..Major depressive disorder causes significant morbidity and mortality. Current therapies fail to fully treat both emotional and physical symptoms of major depressive disorder...
  26. doi Selective muscarinic receptor agonist xanomeline as a novel treatment approach for schizophrenia
    Anantha Shekhar
    Department of Psychiatry, Indiana University School of Medicine, 1111 West 10th St, Suite 313, Indianapolis, IN 46202, USA
    Am J Psychiatry 165:1033-9. 2008
    ..The authors studied xanomeline, a relatively selective muscarinic type 1 and type 4 (M(1) and M(4)) receptor agonist, to determine if this agent is effective in the treatment of schizophrenia...
  27. ncbi A comparison of initial duloxetine dosing strategies in patients with major depressive disorder
    Virgil G Whitmyer
    Lilly Research Laboratories, Eli Lilly and Co, Indianapolis, Ind, USA
    J Clin Psychiatry 68:1921-30. 2007
    ..To compare the effects of starting doses of duloxetine taken with or without food on tolerability and efficacy in patients with major depressive disorder (MDD)...
  28. ncbi The effect of duloxetine on painful physical symptoms in depressed patients: do improvements in these symptoms result in higher remission rates?
    Maurizio Fava
    Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA
    J Clin Psychiatry 65:521-30. 2004
    ..It was hypothesized that resolution of both psychological and physical symptoms of depression would predict a higher percentage of patients achieving remission...
  29. ncbi Duloxetine versus escitalopram and placebo: an 8-month, double-blind trial in patients with major depressive disorder
    Teresa A Pigott
    Department of Psychiatry, University of Florida, Gainesville, FL, USA
    Curr Med Res Opin 23:1303-18. 2007
    ..The current paper focuses on the longer-term (8-month) comparisons of efficacy and safety between duloxetine and escitalopram...
  30. ncbi Evidence for the efficacy of duloxetine in treating mild, moderate, and severe depression
    Richard C Shelton
    Department of Psychiatry, Vanderbilt University School of Medicine, Nashville, Tennessee, USA
    Int Clin Psychopharmacol 22:348-55. 2007
    ....
  31. ncbi Duloxetine in the treatment of major depressive disorder: comparisons of safety and efficacy in U.S. Hispanic and majority Caucasian patients
    Roberto Lewis-Fernandez
    Columbia University College of Physicians and Surgeons, New York State Psychiatric Institute, New York, NY 10032, USA
    J Clin Psychiatry 67:1379-90. 2006
    ..To evaluate new pharmacotherapies for the treatment of major depressive disorder (MDD) in Hispanic Americans, the largest ethnic minority group in the United States...
  32. ncbi Duloxetine for the treatment of major depressive disorder: safety and tolerability associated with dose escalation
    Madelaine M Wohlreich
    Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, Indiana
    Depress Anxiety 24:41-52. 2007
    ..Time course profiles of body weight and heart rate showed modest increases during 2 years of treatment [ClinicalTrials.gov number, NC T000 42575]...
  33. ncbi Duloxetine efficacy for major depressive disorder in male vs. female patients: data from 7 randomized, double-blind, placebo-controlled trials
    Susan G Kornstein
    Department of Psychiatry, Medical College of Virginia Campus, Virginia Commonwealth University, Richmond, USA
    J Clin Psychiatry 67:761-70. 2006
    ..Pooled data from double-blind, placebo-controlled studies were utilized to compare the efficacy of duloxetine in the treatment of major depressive disorder (MDD) in male and female patients...
  34. ncbi Assessing response profiles from incomplete longitudinal clinical trial data under regulatory considerations
    Craig H Mallinckrodt
    Eli Lilly and Co, Lilly Corporate Center, Indianapolis, Indiana 46285, USA
    J Biopharm Stat 13:179-90. 2003
    ..It is further reasoned that in acute phase clinical trials, unstructured modeling of time trends and within-subject error correlations may be preferred...
  35. ncbi Duloxetine in the long-term treatment of major depressive disorder
    Joel Raskin
    Lilly Research Laboratories, Eli Lilly Canada, 3650 Danforth Avenue, Scarborough, Ontario, Canada M1N 2E8
    J Clin Psychiatry 64:1237-44. 2003
    ..This clinical trial evaluated the long-term (1 year) safety and efficacy of duloxetine, a dual reuptake inhibitor of serotonin and norepinephrine, in patients with DSM-IV major depressive disorder...
  36. ncbi Incidence and duration of antidepressant-induced nausea: duloxetine compared with paroxetine and fluoxetine
    John Greist
    Healthcare Technology Systems, Madison, Wisconsin 53717, USA
    Clin Ther 26:1446-55. 2004
    ..This analysis assessed the incidence, severity, onset, and duration of nausea among patients with major depressive disorder (MDD) treated with the new antidepressant duloxetine...
  37. ncbi Duloxetine in the acute and long-term treatment of major depressive disorder: a placebo- and paroxetine-controlled trial
    Michael J Detke
    Lilly Research Laboratories, Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN 46285, USA
    Eur Neuropsychopharmacol 14:457-70. 2004
    ..This placebo-controlled study assesses the safety and efficacy of duloxetine (80 or 120 mg/day) and paroxetine (20 mg QD) during an initial 8-week acute phase and subsequent 6-month continuation phase treatment of MDD...
  38. ncbi Onset of action for duloxetine 60 mg once daily: double-blind, placebo-controlled studies
    Stephen K Brannan
    Cyberonics, Houston, TX, USA
    J Psychiatr Res 39:161-72. 2005
    ..Thus, time to onset of effect is an important attribute of a new pharmacotherapy. We assessed the onset of effect for duloxetine, utilizing analytical methods previously recommended in the literature...
  39. ncbi Duloxetine for the treatment of major depressive disorder in older patients
    J Craig Nelson
    Department of Psychiatry, University of California at San Francisco, San Francisco, CA, USA
    Am J Geriatr Psychiatry 13:227-35. 2005
    ..The efficacy and safety of duloxetine, a dual reuptake inhibitor of serotonin (5-HT) and norepinephrine (NE), were evaluated in the treatment of major depressive disorder (MDD) and associated pain symptoms in patients age 55 and older...
  40. ncbi Safety and tolerability of duloxetine in the treatment of major depressive disorder: analysis of pooled data from eight placebo-controlled clinical trials
    James I Hudson
    McLean Hospital, Belmont, MA, USA
    Hum Psychopharmacol 20:327-41. 2005
    ..To examine the safety and tolerability of the antidepressant duloxetine across multiple studies for major depressive disorder (MDD)...
  41. ncbi Sexual functioning assessed in 4 double-blind placebo- and paroxetine-controlled trials of duloxetine for major depressive disorder
    Pedro L Delgado
    Department of Psychiatry, Case Western Reserve University, Cleveland, Ohio, USA
    J Clin Psychiatry 66:686-92. 2005
    ..Post hoc analyses of pooled data from placebo-controlled studies were utilized to assess sexual functioning in patients receiving duloxetine or paroxetine...
  42. ncbi Duloxetine for the treatment of major depressive disorder in women ages 40 to 55 years
    Vivien K Burt
    Department of Psychiatry and Behavioral Sciences, UCLA School of Medicine, Los Angeles, CA, USA
    Psychosomatics 46:345-54. 2005
    ..Duloxetine (60 mg/day) was demonstrated to be an effective treatment for major depressive disorder in this cohort of women ages 40-55 years...
  43. ncbi An open-label study of duloxetine for the treatment of major depressive disorder: comparison of switching versus initiating treatment approaches
    Madelaine M Wohlreich
    Lilly Research Laboratories, Eli Lilly and Co, Indianapolis, IN 46285, USA
    J Clin Psychopharmacol 25:552-60. 2005
    ..Immediate switching from a selective serotonin reuptake inhibitor or venlafaxine to duloxetine (60 mg QD) was well tolerated...
  44. ncbi Immediate switching of antidepressant therapy: results from a clinical trial of duloxetine
    Madelaine M Wohlreich
    Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN 46285, USA
    Ann Clin Psychiatry 17:259-68. 2005
    ..We examined the efficacy and tolerability associated with a switch from a selective serotonin reuptake inhibitor (SSRI) or venlafaxine to duloxetine...
  45. ncbi Duloxetine in the treatment of major depressive disorder: comparisons of safety and tolerability in male and female patients
    Donna E Stewart
    University Health Network, University of Toronto, Ontario, Canada
    J Affect Disord 94:183-9. 2006
    ..Pooled data from double-blind, placebo-controlled studies were utilized to assess the safety and tolerability of duloxetine in the treatment of major depressive disorder (MDD) in male and female patients...
  46. ncbi Comparing onset of antidepressant action using a repeated measures approach and a traditional assessment schedule
    Craig H Mallinckrodt
    Eli Lilly and Co, Lilly Corporate Center, Indianapolis, IN 46285, USA
    Stat Med 25:2384-97. 2006
    ..The present study assessed the feasibility of comparing onset of action between treatments using a categorical repeated measures approach with a traditional assessment schedule...
  47. ncbi Attrition in randomized controlled clinical trials: methodological issues in psychopharmacology
    Andrew C Leon
    Department of Psychiatry, Weill Medical College, Cornell University, New York, New York 10021, USA
    Biol Psychiatry 59:1001-5. 2006
    ..This information can be used to eliminate some of the very obstacles that lead to attrition, and can be incorporated in data analyses to reduce bias, but it will not eliminate all attrition bias...