The people likely to be prescribed antidepressants are very often excluded from antidepressant registration trials, according to Dr. Sheldon H. Preskorn and his associates.
Using the loosest guidelines for antidepressant registration trial (ART) exclusion, 82% of participants in the Sequenced Treatment Alternatives to Relieve Depression (STAR*D) study would not have been eligible had the study been structured like a normal ART. Of the eight normal inclusion/exclusion criteria, five eliminated more than 10% of the study population: age outside 18-65, Hamilton Depression Rating Scale score below 18, more than 2 months’ duration for current depressive episode, lack of appropriate contraception, and presence of a clinically significant or unstable general medical condition.
Other less significant exclusion criteria included use of disallowed concomitant medication, presence of an Axis II disorder, and suicidality.
“Failure to take these facts into consideration in advance before conducting a study can lead to lost revenue because of failure to develop what could be an effective medication as a result of unsuccessful trials, delays in bringing a drug to market, or the abandonment of this needed area of drug development altogether,” the investigators concluded.
Find the full study in the July issue of the Journal of Psychiatric Practice (J. Psychiatr. Pract. 2015;21:267-74).