Placebo response in bipolar disorder trials is more likely to occur in patients who are mildly ill , bipolar II , mixed-episode , first-episode , rapid cycling , atypical , non-psychotic , substance abusers and medically ill .
The use of concomitant medication such as benzodiazepines , a high frequency of visits , a high number of treatment groups and sites , fixed-dose design s , and the concomitant use of psychotherapy are likely to increase placebo response .
There are a number of clinical and method ological variables that are associated with placebo response
Background :  Placebo response is high in bipolar disorder trials .
This is a challenge for research ers and an enigma for clinicians .
This article will attempt to aid in the comprehension of the ethical questions and method ologies related to the use of placebo in bipolar disorder .
Results : Placebo has a very important role in the study of bipolar disorders .
From a method ological point of view , and given the limitations of non-inferiority design s , the use of placebo is necessary to evaluate the sensitivity of the study and ensure that the drug under investigation is really effective .
Maintenance clinical trials in bipolar disorder: design implications of the divalproex-lithium-placebo study.
Maintenance studies in bipolar disorder have received increased attention in recent years . The interest is driven by apparent contradictions between results of early placebo-controlled trials of lithium and recent open studies , as well as interest in a new group of drugs with mood-stabilizing properties . The multiple outcome indices that require attention in prophylactic bipolar disorder studies add a dimension not present in acute studies of bipolar disorder . We present the methodology of a recently completed r and omized , double-blind , placebo-controlled , parallel-group comparison of divalproex and lithium . We examine the consequences of salient design features , along with their implication s for future studies . A fundamental conclusion is that such maintenance studies should be design ed and executed to emphasize enrollment of patients with relatively active , severe forms of the illness . This goal is not achieved simply , as inherent features of long-term , placebo-controlled studies drive recruitment and enrollment in the direction of patients with milder forms of bipolar disorder . Attention to the frequency of both manic and depressive episodes and the severity of an index manic episode may aid in the selection of patients most suitable for studies design ed to achieve adequate statistical power
Placebo response in bipolar disorder trials is more likely to occur in patients who are mildly ill , bipolar II , mixed-episode , first-episode , rapid cycling , atypical , non-psychotic , substance abusers and medically ill .
The use of concomitant medication such as benzodiazepines , a high frequency of visits , a high number of treatment groups and sites , fixed-dose design s , and the concomitant use of psychotherapy are likely to increase placebo response .
There are a number of clinical and method ological variables that are associated with placebo response
Background :  Placebo response is high in bipolar disorder trials .
This is a challenge for research ers and an enigma for clinicians .
This article will attempt to aid in the comprehension of the ethical questions and method ologies related to the use of placebo in bipolar disorder .
Results : Placebo has a very important role in the study of bipolar disorders .
From a method ological point of view , and given the limitations of non-inferiority design s , the use of placebo is necessary to evaluate the sensitivity of the study and ensure that the drug under investigation is really effective .