Conducting Clinical Trials For Novel Treatments In Psychiatry: A Global Perspective

The last decade of the 20th century and the first decade of the 21st was a period of near-frenzied expansion of clinical trials in psychiatry as the second-generation antipsychotics, selective serotonin reuptake inhibitors (SSRIs) and sero­tonin-norepinephrine reuptake inhibitors (SNRIs) demon­strated their efficacy and safety relative to both placebo and other drugs in their therapeutic classes. These compounds, which are now largely generic, have established a standard of care for the treatment of schizophrenia, depression and all phases of bipolar disorder. Any new therapy must show a meaningful clinical advantage over existing treatments to achieve both regulatory approval and commercial success.