OBJECTIVE: To identify predictors of remission with placebo treatment in double-blind randomized controlled trials (RCTs) in major depressive disorder (MDD). METHOD:A total of 1017 placebo-treated patients with baseline Hamilton Depression rating scale (HAMD) total ≥15 from eight duloxetine RCTs were included. Remission was defined as endpoint (7-8 weeks) HAMD total ≤7. Data were randomly split into training data (N = 813, 80%) for model selection and test data (N = 204, 20%) for validation. Logistic regression and classification and regression tree (CART) methods were used to identify predictors of remission. Predictive accuracy of models was assessed by Receiver Operator Characteristic (ROC) curves. RESULTS: Baseline predictors for remission with placebo consistently identified with the logistic regression and CART analysis were less severe depressive symptoms (based on HAMD core symptoms), younger age, less anxiety (based on HAMD anxiety/somatization), and shorter current MDD episode duration. Associated cut-off values from the CART method characterized patient groups according to their remission likelihood. However, the predictive accuracy was modest for both methods with areas under the ROC curve of 0.6-0.65 based on test data. CONCLUSION: The derived models, although of limited value for predicting remission in individual patients, may be useful for adjusting for placebo effects in clinical trials.
RCT Entities:
OBJECTIVE: To identify predictors of remission with placebo treatment in double-blind randomized controlled trials (RCTs) in major depressive disorder (MDD). METHOD: A total of 1017 placebo-treated patients with baseline Hamilton Depression rating scale (HAMD) total ≥15 from eight duloxetine RCTs were included. Remission was defined as endpoint (7-8 weeks) HAMD total ≤7. Data were randomly split into training data (N = 813, 80%) for model selection and test data (N = 204, 20%) for validation. Logistic regression and classification and regression tree (CART) methods were used to identify predictors of remission. Predictive accuracy of models was assessed by Receiver Operator Characteristic (ROC) curves. RESULTS: Baseline predictors for remission with placebo consistently identified with the logistic regression and CART analysis were less severe depressive symptoms (based on HAMD core symptoms), younger age, less anxiety (based on HAMD anxiety/somatization), and shorter current MDD episode duration. Associated cut-off values from the CART method characterized patient groups according to their remission likelihood. However, the predictive accuracy was modest for both methods with areas under the ROC curve of 0.6-0.65 based on test data. CONCLUSION: The derived models, although of limited value for predicting remission in individual patients, may be useful for adjusting for placebo effects in clinical trials.
Authors: Stephen F Smagula; Meredith L Wallace; Stewart J Anderson; Jordan F Karp; Eric J Lenze; Benoit H Mulsant; Meryl A Butters; Daniel M Blumberger; Breno S Diniz; Francis E Lotrich; Mary Amanda Dew; Charles F Reynolds Journal: J Psychiatr Res Date: 2016-07-07 Impact factor: 4.791
Authors: Rajapillai L I Pillai; Chuan Huang; Andrew LaBella; Mengru Zhang; Jie Yang; Madhukar Trivedi; Myrna Weissman; Patrick McGrath; Maurizio Fava; Benji Kurian; Crystal Cooper; Melvin McInnis; Maria A Oquendo; Diego A Pizzagalli; Ramin V Parsey; Christine DeLorenzo Journal: J Affect Disord Date: 2019-05-28 Impact factor: 4.839
Authors: Ian Joel; Amy E Begley; Benoit H Mulsant; Eric J Lenze; Sati Mazumdar; Mary Amanda Dew; Daniel Blumberger; Meryl Butters; Charles F Reynolds Journal: Am J Geriatr Psychiatry Date: 2013-02-06 Impact factor: 4.105
Authors: R C Kessler; H M van Loo; K J Wardenaar; R M Bossarte; L A Brenner; D D Ebert; P de Jonge; A A Nierenberg; A J Rosellini; N A Sampson; R A Schoevers; M A Wilcox; A M Zaslavsky Journal: Epidemiol Psychiatr Sci Date: 2016-01-26 Impact factor: 6.892
Authors: Shaunna L Clark; Mohammad W Hattab; Robin F Chan; Andrey A Shabalin; Laura K M Han; Min Zhao; Johannes H Smit; Rick Jansen; Yuri Milaneschi; Lin Ying Xie; Gerard van Grootheest; Brenda W J H Penninx; Karolina A Aberg; Edwin J C G van den Oord Journal: Mol Psychiatry Date: 2019-09-09 Impact factor: 15.992
Authors: K J Wardenaar; H M van Loo; T Cai; M Fava; M J Gruber; J Li; P de Jonge; A A Nierenberg; M V Petukhova; S Rose; N A Sampson; R A Schoevers; M A Wilcox; J Alonso; E J Bromet; B Bunting; S E Florescu; A Fukao; O Gureje; C Hu; Y Q Huang; A N Karam; D Levinson; M E Medina Mora; J Posada-Villa; K M Scott; N I Taib; M C Viana; M Xavier; Z Zarkov; R C Kessler Journal: Psychol Med Date: 2014-07-17 Impact factor: 7.723
Authors: Hanna M van Loo; Tianxi Cai; Michael J Gruber; Junlong Li; Peter de Jonge; Maria Petukhova; Sherri Rose; Nancy A Sampson; Robert A Schoevers; Klaas J Wardenaar; Marsha A Wilcox; Ali Obaid Al-Hamzawi; Laura Helena Andrade; Evelyn J Bromet; Brendan Bunting; John Fayyad; Silvia E Florescu; Oye Gureje; Chiyi Hu; Yueqin Huang; Daphna Levinson; Maria Elena Medina-Mora; Yoshibumi Nakane; Jose Posada-Villa; Kate M Scott; Miguel Xavier; Zahari Zarkov; Ronald C Kessler Journal: Depress Anxiety Date: 2014-01-14 Impact factor: 6.505