This also could help to eliminate patients who have been chronica

This also could help to eliminate patients who have been http://www.selleckchem.com/products/bgj398-nvp-bgj398.html chronically symptomatic and have not had a recent exacerbation. In this context, it is also important to consider the presence and potential duration of a washout period (which may or may not be placebo-controlled, double- or single-blind). In some cases, investigators might use this not only to eliminate the adverse effects of

other Inhibitors,research,lifescience,medical drugs, but also to see the severity of untreated symptoms. It is important from an ethical and scientific standpoint that it is clear what the expectations from a washout period really are. In addition, as we will discuss subsequently, we do not have good data on the time course of potential symptom worsening among those patients who are partially treated and who then have their medication discontinued. There are a number of practical

constraints on drug washout, which include increased length of trial duration, hospital Inhibitors,research,lifescience,medical stay, staff requirements, etc. Without an adequate washout, however, it can be difficult to establish a true baseline for both psychopathology and adverse effects. In addition, there might be withdrawal effects from the prior agent,62 which could complicate interpretation of data on a newly instituted medication. The use of a concurrent placebo group can help to mitigate Inhibitors,research,lifescience,medical some of these concerns, and this is one important argument for the use of placebos in such trials Documentation of response to previous treatment in prior episodes can be difficult to obtain on a retrospective basis; however, this can also be important in eliminating potential poor or partial responders. Many current trials stipulate this exclusion criterion, but Inhibitors,research,lifescience,medical little is done to validate these assumptions and, given the pressure to enter subjects, there is likely some slippage in this domain. There is increasing focus on studying patients who have poor or partially responsive symptoms in specific domains of psychopathology, Inhibitors,research,lifescience,medical such as negative, positive, or cognitive dysfunction. The selection of such patients is also a challenge, as the retrospective documentation of the stability- and

persistence of symptoms very despite adequate trials (and with some evidence of treatment adherence) can also be difficult and requires special effort in both the design and execution of appropriate RCTs. In addition, cross-sectionally, negative symptoms can be difficult to differentiate from drug-induced Parkinsonism, depression, demoralization or guardedness. Negative symptoms may also be a secondary (possibly adaptive) response to positive symptoms. Therefore, a longitudinal, prospective approach might be necessary to identify eligible patients for such studies The presence of comorbid substance abuse and/or other psychiatric conditions is often an exclusion criterion in efficacy trials, but not in practical trials.

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