Journal of clinical psychopharmacology
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J Clin Psychopharmacol · Jun 2010
Randomized Controlled Trial Multicenter Study Comparative Study Clinical TrialA pooled MADRS/IDS cross-correlation analysis: clinician and patient self-report assessment of improvement in core depressive symptoms with adjunctive aripiprazole.
These analyses aimed to examine the pattern of improvement in depression symptoms with adjunctive aripiprazole. ⋯ This cross-correlation analysis confirmed that improvement in core depressive symptoms with adjunctive aripiprazole was identified by both clinicians and patients. Clinically, these changes were maintained during the study. Theoretically, these findings lead to important questions regarding neurochemical changes produced by aripiprazole when used in combination with antidepressants.
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J Clin Psychopharmacol · Jun 2010
Comparative StudySurvey of investigators' opinions on the acceptability of interactions with patients participating in clinical trials.
There is growing concern about the ability of clinical trials to reliably detect differences between active drugs and placebo. To date, little attention has focused on how interactions between clinical trial investigators and patients may influence study outcomes. We sought to explore what types of interactions with patients investigators considered to be appropriate during placebo-controlled pharmacotherapy studies of major depressive disorder. ⋯ There is significant variability between PIs in what are considered to be appropriate interactions with patients participating in clinical trials. Greater standardization of these interactions is required to reduce placebo response rates and to strengthen the ethical conduct of clinical trials.