Prediction of placebo response in 2 clinical trials of @entity23695 for the treatment of XXXX .

@entity1 @entity23695 @entity71 @entity146
OBJECTIVE: To search for predictors of placebo response in clinical trials of @entity23695 for the treatment of DSM-IV-TR-defined @entity71 ( @entity71 ) in @entity1 and adults. METHOD: We used data from 2 clinical trials: (1) a 4-week, phase 3, multicenter, randomized, double-blind, forced-dose, parallel-group study of @entity1 aged 6 to 12 years with @entity71 (n = 290) and (2) a 4-week, randomized, double-blind, placebo-controlled, parallel-group, forced-dose titration study in adult subjects, aged 18-55 years with @entity71 (n = 420). Response and remission were defined using the @entity71 Rating Scale-IV and the Clinical Global Impressions-Improvement scale. RESULTS: Symptom remission was inversely correlated with baseline severity in both @entity1 and adults (P < .001), with less robust effects seen for response. The time to response and remission was delayed in adult subjects prescribed placebo versus @entity23695 , while response time in @entity1 was also significantly slower with placebo versus @entity23695 (P < .01). We found little evidence that demographic factors, prior pharmacotherapy, the emergence of adverse events during the trial, or changes in @entity71 symptoms from the screening to baseline assessments predicted placebo response. Certain comorbid medical symptoms reduced the response and remission rates to placebo in @entity1 (P < .001) and adults (P < .001). CONCLUSIONS: In both @entity1 and adults, baseline symptom severity was the most consistent predictor of remission with placebo while the temporal profile of response reliably differentiated placebo from medication responders. Placebo effects are most likely to be minimized in shorter trials enrolling more severely impaired subjects. The impact of medical and @entity146 comorbidities on placebo response merits further investigation. TRIAL REGISTRATION: clinicaltrials.gov identifiers NCT00556296 and NCT00334880.
