Association of End Point Definition and Randomized Clinical Trial Duration in Clinical Trials of Schizophrenia Medications

Analysis of 32 RCTs (n=14,219) submitted to FDA in past 15 years suggests combination of modified version of Positive and Negative Syndrome Scale (19-item) and shortened drug trial duration may provide alternative regulatory pathway to development of new drugs for schizophrenia.

SPS commentary:

An editorial notes that the Positive and Negative Syndrome Scale (PANSS) has been the criterion standard outcome instrument for antipsychotic drug trials for more than 30 years and numerous proposals have been made in the past to modify this scale, but only a few have gained traction. Following this analysis validation studies must be conducted to fully appreciate the value of the modified PANSS, not only to meet the standards of regulatory agencies, but also to ensure that it can function as a distinct and valid instrument.


JAMA Psychiatry

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