Lessons learned from clinical trials investigating minor depressive BGJ398 molecular weight disorder One can use randomized clinical trials in minor depressive disorder as a case study to emphasize some of the challenges faced in trial design and possibly some solutions to these challenges. Minor depressive disorder is an area where there is no consensus about its conceptualization or definition. Some individuals Inhibitors,research,lifescience,medical believe that minor

depression is merely a segue into major depressive disorder, while others consider minor depression an entity in itself.15-17 Some individuals worry that investigating minor depression trivializes the core concept of major depressive disorder, while others consider Inhibitors,research,lifescience,medical it an important part of the spectrum of depressive syndromes.18 Even among those who believe that minor depression is a valid concept that requires rigorous investigation, there is considerable debate about what the definition of minor depression is or should be.19 Furthermore, there is little empirical evidence to support any of the currently employed definitions. Many of the older clinical trials investigating minor depression actually grouped patients into cohorts that contained individuals with major depressive disorder described as being mild in severity. Some of these trials did not differentiate between major depressive disorder

and Inhibitors,research,lifescience,medical a diagnosis of minor depression, but merely stated that those with lower Hamilton Depression Rating Scale (HAMD) scores should be considered as having minor depression. Other trials combined patients with major depression of a milder form with Research Inhibitors,research,lifescience,medical Diagnostic Criteria (RDC) patients with minor depression. Older trials employed either tricyclic antidepressant medications or antipsychotic medications. It is not surprising, based on the side-effect profiles of these agents and the weighting of the HAMD towards somatic concerns, that it was difficult to differentiate an active treatment response from a placebo response. A second Inhibitors,research,lifescience,medical challenge that studies of

minor depression emphasize is the use of rating scales that were developed at another time and for another diagnostic entity to assess minor depression. All of the older studies used the HAMD 17 as a primary outcome measure:20 As discussed above, this rating scale, developed to assess inpatients with endogenous depression, is heavily Vasopressin Receptor weighted toward somatic and/or vegetative factors. This makes the HAMD a ver>’ coarse instrument to use for individuals with milder forms of depression or minor depression, since neither somatic nor vegetative symptoms are highly prominent in such patients. Furthermore, these less highly prominent symptoms tend to be transient in presentation and thus may vary greatly from week to week on a rating scale. This emphasizes the importance of carefully ensuring that the methods of assessment fit the most relevant signs of the syndrome being studied.